#GLP and Non-GLP Toxicology Studies Services
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Exploring Advanced Techniques in Drug Discovery and Research
In the realm of drug discovery and biomedical research, advanced techniques and specialized services are crucial for obtaining accurate and reliable data. Keywords like Non GLP Toxicology, Spatial Biology FFPE, Drug Discovery Histology, and Animal Tissue Histopathology represent cutting-edge methodologies that drive innovation and improve outcomes in research. This article delves into these key areas, highlighting their significance and applications in modern scientific investigations.
Non GLP Toxicology: Flexibility in Early-Stage Research
Non GLP Toxicology refers to toxicology studies conducted without the stringent compliance to Good Laboratory Practice (GLP) regulations. These studies are typically performed during the early stages of drug development to quickly assess the safety profile of new compounds. Non GLP toxicology offers greater flexibility and faster turnaround times, allowing researchers to make informed decisions about which compounds to advance into more rigorous GLP-compliant testing. This approach is cost-effective and efficient, providing valuable insights into the potential toxic effects of new drug candidates.
Spatial Biology FFPE: Unlocking Cellular Interactions
Spatial Biology FFPE (Formalin-Fixed, Paraffin-Embedded) is a technique that allows researchers to analyze the spatial organization of cells and molecules within preserved tissue samples. By applying spatial biology methods to FFPE samples, scientists can investigate the complex interactions and heterogeneity within tissues at a high resolution. This is particularly useful in oncology, where understanding the tumor microenvironment is critical for developing targeted therapies. Spatial biology FFPE combines the robustness of traditional histopathology with advanced imaging and molecular profiling techniques, providing a comprehensive view of cellular dynamics.
Drug Discovery Histology: Visualizing Cellular Changes
Drug Discovery Histology involves the microscopic examination of tissues to study the effects of new drug candidates. Histological analysis is essential for understanding the mechanisms of action, efficacy, and safety of potential therapies. By staining and examining tissue sections, researchers can identify pathological changes, assess tissue damage, and evaluate therapeutic effects. This detailed visualization of cellular changes helps in the identification of promising drug candidates and the optimization of treatment regimens. Drug discovery histology is a cornerstone of preclinical research, providing critical data to guide further development.
Animal Tissue Histopathology: Insights from Preclinical Models
Animal Tissue Histopathology plays a vital role in preclinical research by providing insights into the effects of drugs on various organs and tissues in animal models. Histopathological analysis of animal tissues helps researchers understand the safety and efficacy of new therapies before they are tested in humans. This process involves detailed examination of tissue samples to detect any adverse effects, tissue damage, or pathological changes induced by the drug. Animal tissue histopathology is crucial for ensuring that potential therapies are safe and effective, thereby reducing the risk of failure in clinical trials.
Integrating Advanced Techniques in Research
Integrating techniques such as non GLP toxicology, spatial biology FFPE, drug discovery histology, and animal tissue histopathology into research workflows enhances the quality and depth of scientific investigations. These methodologies provide comprehensive data that supports the development of safer and more effective therapies. By leveraging advanced histological and toxicological analyses, researchers can make more informed decisions, accelerate drug development, and ultimately improve patient outcomes.
The fields of Non GLP Toxicology, Spatial Biology FFPE, Drug Discovery Histology, and Animal Tissue Histopathology represent essential components of modern biomedical research. Each technique offers unique advantages and insights that contribute to the overall success of drug discovery and development. By embracing these advanced methodologies, researchers can enhance their understanding of disease mechanisms, improve the safety and efficacy of new therapies, and drive innovation in the pursuit of better healthcare solutions.
Explore the potential of these advanced research techniques and discover how they can elevate your scientific investigations. Embrace the future of drug discovery with cutting-edge methodologies that provide deeper insights and more reliable data.
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Understanding Preclinical Research: The Key to Successful Innovative Drug Development
The first challenge in drug development is preclinical research of new drugs, which refers to chemical synthesis or natural product purification studies, drug analysis studies, pharmacodynamics, pharmacokinetics, toxicology, and pharmacology studies performed before a drug enters clinical studies. Preclinical studies of new medicines escort the development of innovative drugs.
To New drug registration, it's vital to conduct preclinical research, including studies on the synthesis process, extraction method, physicochemical properties and purity, dosage form selection, prescription screening, preparation process, testing method, quality standard, stability, pharmacology, toxicology, animal pharmacokinetics, etc. Chinese medicine preparation also includes the original herbs' source, processing, and concoction. Biologics has quality standards, preservation conditions, genetic stability, and immunology studies of starting materials such as strains, cell lines, and biological tissues. Medicilon is a preclinical research outsourcing (CRO) company that can provide customizable preclinical trial service solutions with expertise in drug metabolism, pharmacokinetics, pharmacodynamic studies, and toxicology.
Safety evaluation studies in preclinical studies must implement the "Quality Management Practice for Drug Non-clinical Studies" (GLP), and preclinical studies of new drugs include the following.
1, Medicinal Chemistry
Including:
(1) The study of the physical and chemical properties of new drugs such as properties, molecular formula, structural formula, dissociation degree, PH value, physical constants (melting point, boiling point, freezing point, etc.), osmotic pressure, complexes, etc.;
(2) New drug processes research such as route, reaction conditions, production process, and refining methods;
(3) Antibiotic strains, culture media research;
(4) Chemical raw material specifications research;
(5) Animal and plant raw material sources, scientific names, drug names, or extraction site research;
(6) Preparation of prescriptions, process conditions, and refining process research; compound preparations prescription basis. Excipient specification standards, sources, and other research.
2, Pharmacology and Pharmacodynamics Study
Generally include the leading pharmacodynamic research, general pharmacological research, and research on compounded formulations in three aspects. Preclinical pharmacodynamic evaluation is based on the early analysis of new drugs, further systematically evaluating the efficacy of new drugs, drug in vivo processes, drug safety, and mechanism of action of the critical technology, which is a vital part of new drug development and new drugs before entering clinical research.
However, for a long time, it has been common to pay too much attention to safety and less to efficacy and action characteristics, and pharmacodynamic evaluation still needs to include guiding principles and research specifications.
Therefore, reducing subjective factors, increasing the scientific, standardized, and reproducibility of pharmacodynamic evaluation, drawing on advanced experience, and better guiding clinical research are the main tasks of preclinical pharmacodynamic assessment in the future, and establishing a scientific and standardized pharmacodynamic and evaluation platform that is in line with international standards is critical to promote the R&D of innovative drugs in China.
3, Pharmacokinetic research
It mainly refers to the study of the absorption rate of drugs, the degree of absorption, the distribution of organs in the body, and the speed and degree of excretion. Pharmacokinetics is an essential and indispensable research content in the R&D of innovative drugs and even determines the fate of drug development.
Pharmacokinetics is a multi-interdisciplinary discipline that quantitatively studies drug absorption, distribution, metabolism, and excretion (ADME) in the body. Also, it integrates the relevant knowledge of many fields, such as pharmacology, drug analysis, pharmacy, herbal medicine, cell biology, molecular biology, and experimental zoology. Applied pharmacokinetics research mainly includes preclinical evaluation and declaration of innovative drugs, clinical pharmacokinetic study, evaluation of new medications, pharmacokinetic analysis of traditional Chinese medicine and biomolecule drugs, etc.
4、Toxicology research
It includes toxicity tests of systemic drugs, toxicity tests of local medications, and thorough toxicological research (mutagenicity test, reproductive toxicity test, carcinogenicity test, and drug dependence test). Since the 1990s, after optimizing and improving the absorption and bioavailability of drugs through pharmacokinetics and drug metabolism, the toxicity factor of drugs has become one of the main reasons for the failure of new drug development or withdrawal. According to statistics, most withdrawn drugs are accompanied by severe toxic side effects and must be removed from the market with pain.
Understanding the mechanism of toxicity can solve the problem at the root. From the drug discovery and development perspective, studying the mechanism of the toxic effects of drugs can enhance and improve the relevance of drug safety evaluation. In general, toxicologists often study the molecular mechanisms of harmful effects by analyzing the following fundamental questions: How does the toxicant enter the body or cells? How is it distributed and metabolized in the body? How does it interact with target molecules? How do they exert their toxic effects at the molecular level? How does the organism respond to a deadly attack? What are the downstream biological consequences of a harmful attack?
In the development process of new drugs, the first thing to be tackled is efficacy, and only after that, the safety evaluation in terms of toxicity will be carried out. In the development process of many drug candidates, due to the lack of a pharmacological-toxicological database of a series of drugs in a particular field or the lack of prediction ability of some structural fragments by the person in charge, when a lot of human material and financial resources are invested, and the project is gradually carried out to large animals, sometimes there will be people "painful" toxicity problems, and at this time, for the team, is highly embarrassing.
5、Stability study
It mainly includes chemical stability, physical stability, and microbial stability. Stability studies are based on the systematic study and understanding of APIs or formulations and their production processes and the design of tests to obtain the pattern of changes in the quality characteristics of APIs or formulations over time under the influence of various environmental factors (such as temperature, humidity, light exposure, etc.), and accordingly provide supporting information for the prescription, process, packaging, storage conditions, transportation, use and expiration/review period determination of the drug.
Drug stability studies are the process of applying scientific analytical methods and principles to assess the overall quality of a drug product and play an essential role in the entire life cycle of a drug product.
Preclinical research efforts aim to learn as much as possible about all aspects of drugs before they are used in humans, thereby minimizing risk. No one will want to take a medicine that may or may not contain a toxic excipient, nor will anyone want to take a drug with an undetermined amount of active ingredients. Therefore, even at the preclinical stage, developers must demonstrate that they can produce compositionally precise and identical medications at any point in time, even in the case of mass production.
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Agrochemical Toxicology Studies
Supported by an in-house project management and quality team, we operate to the highest quality standards. Supported by an in-house project management and quality team, we operate to the highest quality standards. BOC Sciences has established GLP-certified laboratories that can provide GLP and non-GLP studies through predictive, exploratory and discovery toxicology. Our novel predictive and mechanical testing services include:
Provide toxicology data for re-registration dossier in accordance with the latest regulatory requirements
Create detailed comparative toxicological risk data across species
Screen candidate compounds
Help to develop products that are most beneficial to humans and the environment
We remain at the forefront of toxicology testing, constantly maintaining standards of excellence and innovation to improve research results and efficiency. BOC Sciences supports state-of-the-art infrastructure to ensure reliable, robust toxicology data for your agricultural compound products.
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InflaRx Initiates First-in-Human Study with Small Molecule C5aR Inhibitor INF904
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InflaRx Initiates First-in-Human Study with Small Molecule C5aR Inhibitor INF904
InflaRx N.V.
Randomized, double-blind, placebo-controlled Phase I trial of orally administered complement inhibitor INF904 initiated
Study designed as single ascending dose to determine safety, tolerability and pharmacokinetics in healthy volunteers
Future development in complement-mediated chronic diseases
JENA, Germany, Nov. 09, 2022 (GLOBE NEWSWIRE) — InflaRx N.V. (Nasdaq: IFRX), a clinical-stage biopharmaceutical company developing anti-inflammatory therapeutics by targeting the complement system, today announced that it has dosed its first healthy volunteer in a randomized, double-blind, placebo-controlled Phase I trial of orally administered, small molecule C5aR inhibitor INF904. This single ascending dose Phase I trial aims to evaluate the safety, tolerability and pharmacokinetics of INF904 in healthy volunteers.
“Our preclinical studies with our new orally administered, small molecule C5aR inhibitor INF904 have shown potential for INF904 to inhibit C5a-induced signaling through its receptor C5aR. We are excited to enter clinical development of this new drug candidate,” said Renfeng Guo, M.D., Chief Scientific Officer and Founder of InflaRx. “INF904 is a promising addition to our pipeline of candidates controlling the terminal complement C5a / C5aR pathway. As an orally administered compound, we plan to study if INF904 is especially suitable for patients suffering from complement-mediated chronic autoimmune and inflammatory diseases requiring ongoing long-term treatment,” he added.
In the Phase I first-in-human trial, InflaRx plans to initially enroll approximately 62 healthy volunteers who will be randomly assigned to receive INF904 or placebo. The study will assess single ascending doses under fasted conditions. The main objective of the trial is to assess safety and tolerability. Secondary endpoints include several pharmacokinetic parameters. The effect of INF904 on C5a-induced downstream activity will also be explored.
Story continues
As reported in January 2022, INF904 showed anti-inflammatory therapeutic effects in several preclinical disease models and there were no obvious toxicological findings in investigational new drug (IND)-enabling (preclinical) studies, including required good laboratory practice (GLP) toxicity analyses. In these preclinical studies, oral INF904 showed higher plasma exposure in animals, including non-human primates, and improved neutrophil-inhibitory activity in a hamster model compared to a marketed C5aR inhibitor. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has substantially less inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. InflaRx plans to study INF904 for the treatment of complement-mediated, chronic autoimmune and inflammatory diseases where oral administration is the preferred choice for patients.
About InflaRx N.V.:
InflaRx (Nasdaq: IFRX) is a clinical-stage biopharmaceutical company focused on applying its proprietary anti-C5a and C5aR technologies to discover and develop first-in-class or best-in-class, potent and specific inhibitors of the complement activation factor known as C5a and its receptor known as C5aR. Complement C5a and its receptor C5aR are powerful inflammatory mediators involved in the progression of a wide variety of autoimmune and other inflammatory diseases. InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de.
Contacts:
InflaRx N.V.
e-mail: [email protected]
MC Services AG
Katja Arnold, Laurie Doyle, Dr. Regina Lutz e-mail: [email protected] Europe: +49 89-210 2280 US: +1-339-832-0752
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential” or “continue” and similar expressions. Forward-looking statements appear in a number of places throughout this release and may include statements regarding InflaRx’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the Company’s ongoing and planned preclinical development and clinical trials, including the planned clinical trial of INF904 and the safety, tolerability and efficacy thereof; the Company’s interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways; the impact of the COVID-19 pandemic on the Company; the timing and its ability to commence and conduct clinical trials; potential results from current or potential future collaborations; its ability to make regulatory filings, obtain positive guidance from regulators, and obtain and maintain regulatory approvals for its product candidates; its intellectual property position; its ability to develop commercial functions; expectations regarding clinical trial data; decisions regarding the strategic direction of the Company; its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies; the industry in which the Company operates; the trends that may affect the industry or the Company’s business; and the risks, uncertainties and other factors described under the heading “Risk Factors” in InflaRx’s periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and InflaRx assumes no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
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In vivo CRO Market Expected To Achieve Lucrative Growth By 2025
The global in vivo cro market is anticipated to reach USD 5.81 billion by 2026, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 8.5% during the forecast period. Increasing focus on core competencies by the pharmaceutical players coupled with economic efficiency offered for outsourcing is expected to boost the demand.
In Addition, the CROs are equipped with a competent workforce capable of performing a diverse number of tasks along with being well-versed through regulatory requirements. Also, the pressure from the increasing competition owing to rapid growth of generics, patent expirations, and introduction of biosimilar equivalents are encouraging pharmaceutical companies to take the aid of such organizations.
Increasing mergers and collaborations have propelled the value of pharmaceutical outsourcing with major industry contributors expanding into developing regions. The year 2015 experienced high valued transactions as a result of LabCorp acquiring Covance for USD 5.5 billion and the Chinese Private Equity Group acquiring WuXifor USD 3.3 billion. The patent cliff, high research and development cost involved, and globalization in the clinical trial process has driven the
To request a sample copy or view summary of this report, click the link below: www.grandviewresearch.com/industry-analysis/in-vivo-cro-market
Further key findings from the report suggest:
Rodent based In vivo CRO led the market in 2018 and is anticipated to remain dominant throughout the forecast period. Mice is the most used animal for preclinical evaluation and accounted for almost 76% of the market share in 2018.
Based on indication, oncology held the largest market share in 2018, attributed to the increasing number of cancer cases and focus of pharmaceutical players on introducing novel drug treatments with fewer side-effects
North America led the global In vivo CRO market in 2018 owing to the presence of technologically advanced CROs
Asia Pacific is anticipated to register the fastest CAGR over the forecast period. Constantly improving healthcare infrastructure, huge patient base, presence of untapped opportunities, and economic development, are some factors responsible for the rapid growth
Some of the key market players include Pharmaceutical Product Development, LLC (PPD); IQVIA; American Preclinical Services, LLC.; Charles River Laboratories; Parexel International Corporation; ICON Plc; Covance Inc.; Theorem Clinical research; inVentiv Health; WuXi AppTec, Inc.; American Preclinical Services, LLC.; and Evotec (US), Inc. Partnership and mergers and acquisitions are the key strategic undertakings by these players
Grand View Research has segmented the global In vivo CRO market based on product type, GLP type, indication, and region:
In vivo CRO Product Type Outlook (Revenue, USD Million, 2015 - 2026)
Rodent Based
Rats
Mice
Others
Non-Rodent Based
Hamsters
Guinea Pigs
Gerbils
Others
In vivo CRO GLP Type Outlook (Revenue, USD Million, 2015 - 2026)
Non GLP
In House
Outsourcing
GLP Toxicology
In House
Outsourcing
In vivo CRO Indication Outlook (Revenue, USD Million, 2015 - 2026)
Autoimmune/Inflammatory Conditions
Rheumatoid Arthritis
Multiple Sclerosis
Osteoarthritis
Irritable Bowel Syndrome
Others
Pain Management
Chronic Pain
Acute Pain
Oncology
Blood Cancer
Solid Tumor
Syngeneic Model
Patient Derived Xenograft
Xenograft
Others
CNS conditions
Epilepsy
Parkinson’s Disease
Huntington’s Disease
Stroke
Traumatic Brain Injury
ALS
Muscle Regeneration
Others
Diabetes
Obesity
Others
In vivo CRO Regional Outlook (Revenue, USD Million, 2015 - 2026)
North America
U.S.
Canada
Europe
U.K.
Germany
France
Italy
Spain
Asia Pacific
India
China
Japan
Australia
South Korea
Latin America
Brazil
Mexico
Argentina
Colombia
Middle East & Africa
South Africa
Saudi Arabia
UAE
About Grand View Research
Grand View Research, Inc. is a U.S. based market research and consulting company, registered in the State of California and headquartered in San Francisco. The company provides syndicated research reports, customized research reports, and consulting services. To help clients make informed business decisions, we offer market intelligence studies ensuring relevant and fact-based research across a range of industries, from technology to chemicals, materials and healthcare.
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GLP Tox Toxicology Dose Escalation
GLP Tox Poisonous Expander Review
When it comes to studying and researching the effects of toxins on our health, there's no substitute for GLP Tox Toxicology Dose Escalation as our first line of defense. There's a wealth of information out there on various toxic substances, and when it comes to toxicology, we need the very best sources available. And where can they be found? The GLP Tox Toxicology Dose Escalation is your answer!
If you want to know about the toxicity of lead, mercury, cysts, VOCs, lead, asbestos and other dangerous chemicals, you can rely on the GLP Tox Toxicology Dose Escalation service to provide you with accurate, up-to-date toxicological information. For your information, the primary goal of this service is to conduct inter-particle level analysis (IPLA's). This will determine the toxicities of thousands of compounds and will help healthcare professionals make informed decisions about treatment.
With the help of the GLP Tox Toxicology Dose Escalation service, healthcare professionals can protect themselves and their patients from exposure to toxic substances. It is the single most important step in the process of toxicology, as it determines the level of toxicity at the microscopic level. The various types of analytical methods used by the GLP Tox Toxicology Dose Escalation service include Electron Microscopy, Gas Chromatography/Mass Spectroscopy, Ultraviolet Gas Analysis, Novel Microassays and Environmental Sampling. There are many other laboratory services that the company offers to ensure that your laboratory toxicology test is as accurate and comprehensive as possible.
There have been a number of reports of drug-related deaths in the United States, which have led to significant levels of concern about healthcare practice. As pharmaceutical companies scramble to find solutions for their tainted supply of prescription medications, more patients are suffering from health conditions that can be traced to these drugs. Between prescription drug abuse and contamination of drinking water, toxicology has become an increasingly important part of the medical community. These toxicities can lead to serious consequences if left unchecked.
There have been a number of cases in which patients have been exposed to hazardous waste products in nursing homes and other health care facilities. GLP Tox Toxicology Dose Escalation services are necessary in order to contain these potentially dangerous materials before they pose a hazard to patients. However, there has also been an increase in the cases of exposure to harmful drugs in medical settings. This has prompted organizations such as the American Society of Clinical Oncology to launch a national program to educate doctors about the need to regularly update their radiology departments on GLP Tox Toxicology Dose Escalation methods. The organization hopes that this will lead to a decrease in the number of needless deaths caused by unnecessary exposure to harmful substances.
Currently there is not enough evidence to suggest that toxic exposure to many common laboratory compounds or pharmaceuticals leads to chronic health problems or increased mortality rates. However, it is becoming evident that the number of deaths caused by toxicology testing continues to rise. In response to this, healthcare organizations have been working hard to come up with methods to reduce the number of unnecessary toxicology tests.
Currently there are several on the market that provide accurate toxicology results in a matter of minutes. These non-surgical tests do not require the use of any special equipment in order to conduct. All that is needed is a sample of bodily fluids, which can be drawn from the throat, stomach, or any other readily accessible body fluid. This test is fast and reliable, and is widely used in various fields of pharmaceutical and clinical toxicology research. Because the procedure involves no needles or other hidden or foreign objects, the potential for contaminated blood or serum is practically eliminated.
Toxins are everywhere, and many people may not even realize that they are exposed to them every day. The use of the GLP Tox Expander ensures that toxicology testing is conducted safely and repeatedly, giving the healthcare community peace of mind that their patients are receiving the highest quality care possible. By maintaining consistent and speedy toxicology test durations, physicians and healthcare facilities are ensuring that the health and safety of patients remain a priority.
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Benefiting from the national gene vector biorepository
IMAGE: Official Journal of the European Society of Gene and Cell Therapy and eight other international gene therapy societies, was the first peer-reviewed journal in the field and provides all-inclusive access… view more
Credit: Mary Ann Liebert, Inc., publishers
New Rochelle, NY, March 26, 2020—Gene therapy investigators can greatly benefit from the resources and services provided by the National Gene Vector Biorepository (NGVB), housed at the Indiana University School of Medicine. These include 93 unique reagents, a searchable database of animal safety studies, and Replication Competent Virus Testing, as detailed in an article published in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. Click here to read the full-text article free on the Human Gene Therapy website through April, 26 2020.
“The National Gene Biorepository: Eleven Years of Providing Resources to the Gene Therapy Community” was coauthored by Kenneth Cornetta, Lorraine Matheson, Ryan Long, and Lisa Duffy, Indiana University School of Medicine, Indianapolis.
The Reagent Repository has distributed more than 1,000 reagents to nearly 400 investigators. Included in the repository are reagents such as plasmids for adeno-associated virus (AAV) gene transfer and cell lines used to manufacture retroviral, lentiviral, adenoviral, and AAV gene therapies. Also included in the NGVB’s resources and services is the Pharmacology and Toxicology (Pharm/Tox studies) Good Laboratory Practice (GLP) archive for storing samples from pharm/tox studies.
The authors describe three main rationale for offering NGVB services: decreasing the risk of non-compliance with FDA requirements; addressing the disconnect between clinical trial grant funding periods and extended post-trial monitoring requirements; and reducing costs.
“The NGVB resource is one of the key elements in the NIH strategy to enable academic researchers to pursue early phase clinical trials of their gene therapies with or without industry involvement,” says Editor-in-Chief Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School, Worcester, MA. “Without such resources, the cost of these services would otherwise be prohibitive for academic scientists, and their work would perish in the proverbial ‘valley of death’
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About the Journal
Human Gene Therapy, the Official Journal of the European Society of Gene and Cell Therapy and eight other international gene therapy societies, was the first peer-reviewed journal in the field and provides all-inclusive access to the critical pillars of human gene therapy: research, methods, and clinical applications. The Journal is led by Editor-in-Chief Terence R. Flotte, MD, Celia and Isaac Haidak Professor of Medical Education and Dean, Provost, and Executive Deputy Chancellor, University of Massachusetts Medical School, and an esteemed international editorial board. Human Gene Therapy is available in print and online. Complete tables of contents and a sample issue are available on the Human Gene Therapy website.
About the Publisher
Mary Ann Liebert, Inc., publishers is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Nucleic Acid Therapeutics, Tissue Engineering, Stem Cells and Development, and Cellular Reprogramming. Its biotechnology trade magazine, GEN (Genetic Engineering & Biotechnology News), was the first in its field and is today the industry’s most widely read publication worldwide. A complete list of the firm’s 90 journals, books, and newsmagazines is available on the Mary Ann Liebert, Inc., publishers website.
Disclaimer: We can make mistakes too. Have a nice day.
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#CELL BIOLOGY#DISEASE IN THE DEVELOPING WORLD#ENVIRONMENTAL HEALTH#gene therapy#INFECTIOUS/EMERGING DISEASES#MEDICINE/HEALTH
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Contrast Media Market 2025 Forecasts By Global Industry Analysis In 2020 Report
Based on data by Market Research Future this report on ‘Contrast Media Market’ delivers a succinct analysis on industry size, regional growth and revenue forecasts for the upcoming years. The report further sheds light on significant challenges and latest growth strategies adopted by manufacturers who are a part of the competitive spectrum of this business domain.
Contrast Media Market Overview
Contrast Media is a substrate used during medical imaging to enhance the contrast of fluids in the body, basically to enhance the visibility of blood vessels and GI tract. Over the past couple of years, contrast media has evolved dramatically, making phenomenal headways in terms of product developments and their approvals. This, as a result, has helped the market to garner exponential traction, worldwide, addressing the augmented demand and meeting the expectations of patients and radiologists, simultaneously.
Acknowledging the exponential growth, the market perceives currently, Market Research Future (MRFR), in its recently published study report asserts that the global contrast media market will further create a substantial revenue pocket by 2023, registering approximately 6.3% CAGR throughout the forecast period (2017 – 2023). The increasing number of approvals for contrast agents are positively impacting the market.
Read more news on: https://www.medgadget.com/2020/06/covid-19-outbreak-impact-on-contrast-media-market-2020-global-report-industry-size-share-growth-top-companies-analysis-upcoming-trends.html
Burgeoning healthcare sector, technological advancements in medical imaging technology and techniques are some of the key driving forces behind the growth of the market. These advancements have introduced improved utilization of most of the existing contrast media agents while presenting the innovative agents.
Besides, factors such as the rising prevalence of various chronic diseases such as GIT, Cancer, Cardiac diseases and increase in the number of public as well as private diagnostic centers to improve diagnostic imaging services are fostering the demand for various diagnostic imaging modalities.
On the flip side, factors such as the risk of side / adverse effects of the contrast media might poses challenges in market growth. Nevertheless, advantages offered by the technological innovations are expected to support the market growth, by bringing improvements in the functionalities of these media.
Similarly, a robust range of products brought about by the market players by increasing research activities working towards the applications of various contrast agents, are paving the ways for the market growth potential.
Syringeless contrast media injectors are the latest trend of the market owing to their efficacy in minimizing the wastage of media coupled with the and software advancements that bring ease in the use of the devices.
Due to the increased use of off-pump CABG procedures, the risk of AKI with CABG versus PCI is decreasing. This defines the increased use of off-pump CABG procedures, which might be safer for the kidneys.
Global Contrast Media Market – Segments
For enhanced understanding, the report has been segmented into five key dynamics.
By Type : Iodine-based, and Intravenous Contrast Materials among others.
By Procedure : X-ray, Computed Tomography, Ultrasound, and Magnetic Resonance Imaging among others.
By Application : Oncology, Cardiovascular Disorders, and Nephrological Disorders among others.
By Route of Administration : Oral, Injectable, and Rectal
By Regions : Asia Pacific, North America, Europe, and the Rest-of-the-World.
Global Contrast Media Market – Geographical Analysis
The North American region, heading with the technological advancements, dominates the global contrast media market with a significant market share. Moreover, factors such as the increasing prevalence of GI disease and advancements in medical science drive the growth of the regional market. Similarly, factors such as the huge uptake of advanced technologies and increasing emphasis of market players on delivering cost-competitive contrast media foster the growth of the regional market.
The European contrast media market, backed by improving economic conditions in the region has emerged as another lucrative market, globally. Additionally, factors such as increasing healthcare expenditures, the adoption of advanced technologies, and the presence of global players foster the growth of the medical supplies market in the region.
The contrast media market in the Asia Pacific region, led by the rapidly proliferating healthcare sector and developing economy, has emerged as a promising market, globally. Increasing markets in countries, such as Japan, China, and India, are pushing up the growth in the regional market. Moreover, the APAC contrast media market is driven by the rising population and the spreading awareness towards the functionalities of contrast media.
Global Contrast Media Market – Competitive Landscape
Fiercely competitive, the contrast media market appears to be fragmented owing to the presence of numerous matured & small players. Matured players try to gain a competitive edge through strategic initiatives such as acquisition, partnership, expansion, collaboration, and product & technology launch. They invest heavily in R&D to develop a manufacturing technique that is entirely on a different level compared to their competition.
Contrast Media Market Major Players:
Key players leading the global contrast media market include Daiichi (Japan), Bayer Healthcare Pharmaceuticals (Germany), GE Healthcare (US), NanoScan Imaging (US), Medrad Inc. (US), Guerbet Group (France), Targeson (US), AMAG Pharmaceuticals (US), Bracco Diagnostic Inc. (Italy), Lantheus Medical Imaging (U.S.), Covidien (Ireland), nanoPET Pharma GmbH (Germany), Subhra Pharma Private Limited (India), CMC Contrast AB (Sweden), and Mallinckrodt Pharmaceuticals (UK) among others.
Contrast Media Industry, Innovation & Related News
February 06, 2019 – Imagion Biosystems Limited (Australia), a leading global company dedicated to improving healthcare through the earlier detection of cancer announced achieving a key milestone in its progress to first-in-human testing with the commencement of a toxicology safety study of its lead nanoparticle formulation for the detection of HER2 metastatic breast cancer. Imagion is developing a new non-radioactive and safe diagnostic imaging technology.
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Untargeted iron oxide nanoparticles that have been shown to be bio-safe and are used off-label as an MRI contrast agent, but their lack of specificity has limited their diagnostic utility. Based on recommendations from the U.S. FDA, the Company has engaged a contract research organization to undertake the toxicology study following Good Laboratory Practices (GLP).
December 05, 2018 --- Guerbet (France), a leading global manufacturer of contrast agents launched its multi-use OptiVantage contrast media injector in Europe. At the event, the company also announced that the OptiVantage multi-use contrast media injector which is designed for injecting contrast agents used in computed tomography (CT) scan medical examinations is now CE marked.
#Contrast Media Market#Contrast Media Market Size#Contrast Media Market Share#Contrast Media Market Growth#Contrast Media Market Analysis
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Analysis of the importance of pharmacokinetics in preclinical studies
In the process of new drug development, it is necessary to conduct pharmacokinetic studies to analyze the pharmacokinetic parameters of drugs in vivo and use them as their outstanding advantages and effects.
Generally speaking, drugs with exceptional benefits should have shallow toxic side effects, good pharmacodynamic and pharmacokinetic properties, high efficiency of utilization and absorption, high solubility, and low toxicity of metabolites in vivo, etc., which can be used to guide new drug development and clinical drug use.
The drug’s utilization and absorption efficiency are relatively high, and it has relatively high solubility. Moreover, the toxicity of metabolites in the body is relatively low, which can be used to guide the development of new drugs and clinical medication.
Pharmacokinetics is a discipline that adopts mathematical principles and methods to quantitatively analyze and describe the dynamic processes of drugs and their regularity in vivo, which can quantitatively study the absorption, distribution, metabolism, and excretion patterns of drugs in living organisms. Mediiclon Pharmacokinetics Lab has passed the GLP certification by NMPA. Following the guiding principles of ICH, NMPA and FDA. The lab offers in vivo and in vitro pharmacokinetic tests according to the needs of our clients and provides them with complete sets of pharmacokinetic evaluation and optimization services.
The application of pharmacokinetics in pharmacological research
A drug needs to maintain the corresponding concentration and reach the related target site and the affiliated site of action for effective binding, to produce drug-receptor interactions and the corresponding pharmacological effects. The strength of the pharmacological effect is critical and related to the relevant factors, mainly the concentration of the drug at the site of action.
For example, the strength of Furosemide diuretic has a linear relationship with Na+ excretion, urine flow, and blood concentration; salicylic acid has an analgesic effect when it reaches 50-100mg/L in the body anti-rheumatic effect when the attention is more significant than 250mg/L, anti-inflammatory effect when the concentration is 350-450mg/L; toxic side effects will occur when the concentration is more important than 500mg/L; toxic death will happen when the attention is 1600mg/L-1800mg/L. The study of pharmacokinetics can further investigate the pharmacological effects of the drug to guide the clinical use of the drug.
Application of pharmacokinetics to toxicology studies
In toxicology research, drug metabolism kinetics and toxicity tests are fully integrated and linked to explore the laws of adverse reactions and drug toxicity to guide toxicology research. Toxicokinetics is the link between clinical and non-clinical trials, mainly to determine the relationship between comparative systemic toxicity, exposure, and toxicokinetic data over time. It can be used to explain the toxicological findings or changes in the drug in the trial, thus providing a basis for preclinical toxicity testing through the study of metabolites and revealing the mechanism of action of toxicity.
The application of pharmacokinetics in formulation research
High-quality drug dosage forms have distinct advantages and characteristics, including safety, stability, etc. The practical application of pharmacokinetics positively affects the acute and effective screening and evaluation of drugs.
On this basis, it provides an essential guarantee for the scientific and rational use of clinical medicines to ensure the safety of clinical drug use. In China and abroad, comprehensive and in-depth research has been conducted on targeted and controlled release formulations, which have become a hot issue of great concern. They can maintain the effective concentration of drugs, reduce the number of doses to a certain extent, and reduce their side effects. Through a comprehensive and in-depth study of the pharmacokinetics of formulations, we can effectively evaluate various dosage forms of drugs and effectively combine and link them with the relevant regulations and requirements.
The biological activity and activity intensity of drugs in vivo are closely related to their absorption, distribution, metabolism, and excretion processes and characteristics in vivo, so the in-depth study of drug metabolism kinetics has specific hints and guidance to reveal their biological effects and mechanisms of action in vivo. With the development of the discipline and the improvement of research technology, the impact of drugs on the drug disposal system of organisms such as transporters and metabolic enzymes also belongs to the research of drug metabolism kinetics. The disposition of drugs in the organism determines to a certain extent, the strength of its efficacy or toxicity, so the study of pharmacokinetics has a vital role and significance in the process of innovative drug development.
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Preclinical CRO Market Growing Strong-MRFR
Preclinical CRO Market Overview:
The global market for the preclinical CRO market is getting backed by several factors like increasing investment in the pharmaceutical and biopharmaceutical sector, availability of additional value-added services, mutual benefits, a surge in the number of drugs for preclinical phase, and others. The global market is on track to surpass a valuation worth USD 5234.7 million during the forecast period of 2019 to 2024, with a CAGR of 8.14%. The constant growth in outsourcing can also propel the market’s growth.
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Preclinical CRO Market Segmentation:
The global market for preclinical CRO has been segmented on the basis of service, application, and end user to facilitate a study that would ease the process of deciding the future course of action. These segments will also reveal details regarding factors and their impact on production volume and revenue.
By service, the global preclinical CRO market has been segmented on the basis of toxicology testing, bioanalysis, drug metabolism and pharmacokinetics (DMPK) studies, and others. The toxicological testing segment will lead the global segment and its market valuation can surpass USD 2,476.28 Million by the end of 2024.
By application, the market study reveals segments like oncology, central nervous system (CNS) disorders, immunological disorders, respiratory diseases, cardiovascular diseases, diabetes, infectious diseases, and others. The growing occurrence of cardiovascular diseases can provide traction to the market. The oncology segment can also impact substantially.
By end user, the global market is getting studied on the basis of pharmaceutical and biopharmaceutical industries, medical device companies, and academic institutes. The pharmaceutical and biopharmaceutical industries are expected to make good ground as the investment in rising in the sector.
Preclinical CRO Market Regional Analysis:
The Americas had an over 40% market share in 2018, which made them the largest contributor. This control over the global market is expected to continue. Asia Pacific has the chance to outpace others with a 9.44% CAGR during the forecast period.
Preclinical CRO Market Competitive Landscape:
The global market for preclinical CRO us depending largely on the contributions made by companies like Envigo (US), Charles River (US), IQVIA (US), PAREXEL International Corporation (US), PRA Health Sciences (US), WuXi AppTec (China), Eurofins Scientific (Luxembourg), ICON PLC (Dublin), Pharmaceutical Product Development, LLC (US), Medpace (US), Laboratory Corporation of America Holdings (US), and MD Biosciences (US). Their endeavors are mainly focused on expanding the market reach and portfolio. For this, they took the routes concerning mergers, collaborations, acquisitions, innovations, spurring their expenditure for the research and development sector, and others. This also included a detailed approach dealing with marketing strategies like branding and launching plans. MRFR listed the latest changes in their report to make the study more comprehensive.
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Industry News:
In May 2020, Experimentica Ltd. announced that they have taken over the contract research division from Ophthy-DS, Inc. with a specialization in non-regulated drug discovery services and medical device testing for diverse ophthalmic indications. The company has made a significant name in the market as a leader in preclinical ophthalmic drug discovery services. Ophthy-DS, Inc. is a Michigan-based company with a substantial impact on the preclinical contract research organization (CRO) segment. This acquisition with cement Experimentica’s position in North America and boost its position as a leading service provider.
In May 2020, Altogen Labs announced that they would be offering in vivo xenograft efficacy studies and pharmacology/toxicology services that have been designed to increase the speed of preclinical research and drug development. The company has already made a name in the market as a GLP-compliant contract research laboratory (CRO).
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In Vitro Toxicity Testing Market Size, Share, Outlook, and Opportunity Analysis, 2020 - 2027
In vitro toxicology testing is used to examine the toxic properties of compounds and mixtures on cultured bacteria or mammalian cells. Absorption, distribution, metabolism, and excretion (ADME), and toxicological profiling plays a major role in drug development. It focuses on obtaining an early estimate of human pharmacokinetic and metabolic profiles.
The global in vitro toxicity testing market is estimated to account for US$ 14,940.2 Mn in terms of value by the end of 2027.
Browse Summary of the Research Report-https://www.coherentmarketinsights.com/market-insight/in-vitro-toxicity-testing-market-3855
Opposition to animal testing is expected to propel growth of the global in vitro toxicity testing market over the forecast period. Concerns over animal experiments have been raised in the field of toxicity testing, owing to issues such as difference between various test animals and the resultant effect of toxicants on the animals. Various animal welfare associations and organizations have also increased their efforts towards elimination of toxicity testing on animals. Such scenario has led to increasing adoption of in vitro toxicity testing.
Moreover, various advantages of in vitro toxicity testing are also expected to aid in growth of the market. In vitro toxicity testing eliminates the use of animals from the testing procedures. It also covers a wide range of toxicity pathways and thus helps in convenient testing. This method also gives sufficient detection of toxic effects on the organisms at very low concentration, which is otherwise not possible in animal testing.
North America held dominant position in the global in vitro toxicity testing market in 2019, accounting for 32.9% share in terms of value, followed by Europe and Asia Pacific, respectively
Questionable predictive power of in vitro toxicity testing is expected to hinder growth of the market. As compared to the conventional animal testing, in vitro toxicity testing has not turned out to be a more reliable predictor. Although in vitro cytotoxicity assays have been used by scientists in drug testing, it has not been consistently applied to the decision making involved in early drug development.
Moreover, the influence of nanomaterial properties on the outcome of in vitro toxicity testing through assay interference is also expected to limit growth of the market. Such interference can lead to false positive or false negative results.
Strict regulations banning animal testing are expected to offer lucrative growth opportunities for players in the global in vitro toxicity market. For instance, in January 2020, the state governments of California, Nevada, and Illinois banned the sale or import of animal-tested cosmetics.
Moreover, increasing demand for personal care products is also expected to aid in growth of the market. For instance, according to India Brand Equity Foundation, the beauty, cosmetic and grooming market in India is expected to reach US$ 20 billion by 2025.
The global in vitro toxicity testing market was valued at US$ 4,745.9 Mn in 2019 and is forecast to reach a value of US$ 14,940.2 Mn by 2027 at a CAGR of 15.4% between 2020 and 2027.
Major regulatory bodies are focused on providing guidelines for in vitro toxicity testing. For instance, in January 2020, the U.S. FDA finalized its In Vitro Guidance for the pharmaceutical industry in order to help drug developers plan and evaluate studies to determine the drug-drug interaction potential of an investigational drug product.
The market is witnessing increasing adoption of Next Generation Sequencing (NGS) as an alternative or supplement to conventional in vivo or in vitro testing methods for biologics testing. For instance, in January 2020, PathoQuest, a strategic partner of Charles River Laboratories International Inc., received its GLP certificate for advanced NGS viral safety testing from the French National Agency for Medicine and Health Products Safety.
Global In Vitro Toxicity Testing Market: Competitive Landscape
Major players operating in the global in vitro toxicity testing market include, Bio-Rad Laboratories, Inc., Cyprotex, Charles River Laboratories International Inc., and Covance Inc.
Global In Vitro Toxicity Testing Market: Key Developments
Major players in the market are focused on adopting collaboration and partnership strategies to expand their product portfolio. For instance, in January 2019, LabCorp, along with its subsidiary Covance Inc., partnered with GENFIT, a biopharmaceutical company focused on R&D in liver diseases, for access to non-alcoholic steatohepatitis liver diagnostic test for the clinical research market.
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In vivo CRO Market Size and Growth Factors Research and Projection 2027
In vivo CRO Market Overview:
The report studies In vivo CRO in Global market Professional Survey 2019: Industry Trends, Industry Growth, Size, Share, Drivers, Restraints, Opportunities, Production, Segmentation, Pricing, Value, Volume, Company Profiling, Competitive Landscape, Product Portfolio, and Specifications for the Forecast Period till 2026.
This market intelligence study curates an exhaustive database of industrial essentials for formulating favourable strategies. A thorough investigation of the value chain and the distribution channel is provided in this study by business professionals. The In vivo CRO Market study offers detailed information pertaining to the extent and application of the market, which helps better understand the global sector. This report on the Global In vivo CRO Market discusses several growth prospects, including the industry sectors, current trends, up-to-date outlines, driving factors, and hurdles, overall offering market projections for the coming years.
Market Size – USD 3027.2 Million in 2018, Market Growth - CAGR of 8.4%. Market Trends – Funding for R&D activities and Strategic developments for In vivo CRO Market.
This report covers the recent COVID-19 incidence and its impact on In vivo CRO Market. The pandemic has widely affected the economic scenario. This study assesses the current landscape of the ever-evolving business sector and the present and future effects of COVID-19 on the market.
View Full Report Description with TOC: https://www.reportsanddata.com/report-detail/in-vivo-cro-market
The In vivo CRO market is heavily consolidated owing to a large number of global, regional, and local key contenders having already established a significant footing. The key participants dominate the operations in the industry with their extensive geographical coverage and huge production facilities. Players operating in this market are in intense competition in terms of technological innovations, product development, and product pricing. To gain a competitive edge over the other competitors in the In vivo CRO industry, the leading players are focusing more on ways to offer products at attractive prices.
Leading Players in In vivo CRO Market:
American Preclinical Services, LLC, BTS Research, Charles River Laboratories, Chiltern International Ltd., Crown Bioscience, Eurofins Scientific, Evotec, ICON PLC, INC Research, inVentiv Health, Parexel International, Pharmaceutical Product Development, LLC (PPD), PRA Health Sciences, Quintiles, Taconic Biosciences and Theorem Clinical Research.
Segmentation:
Type (Revenue, USD Million; 2016–2026)
Rodent-Based
Non-Rodent Based
GLP Type (Revenue, USD Million; 2016–2026)
Non-GLP
GLP Toxicology
Indication (Revenue, USD Million; 2016–2026)
Autoimmune/Inflammatory Conditions
Pain Management
Oncology
CNS conditions
Diabetes
Obesity
Others
Regional In vivo CRO Market (Regional Output, Demand & Forecast by Countries):-
North America (United States, Canada, Mexico)
South America (Brazil, Argentina, Ecuador, Chile)
Asia Pacific (China, Japan, India, Korea)
Europe (Germany, UK, France, Italy)
Middle East Africa (Egypt, Turkey, Saudi Arabia, Iran) and More.
Read full Press Release at: https://www.reportsanddata.com/press-release/global-in-vivo-cro-market
What are the market factors that are explained in the report?
1. Market dynamics: The Automotive Evp (Electric Vacuum Pump) 5 report also assesses the various commercial possibilities that are expected to be revealed in the near future and the positive revenue forecasts in the years ahead. It also studies the key markets and explores different geographies where the industry is established.
2. Competitive Market Share: The key players focus their operations in the sector in select regions, owing to their robust geographic reach and huge production facilities. Players operating in this market are in intense competition in terms of technological advancements, product development, and product pricing. To gain a competitive upper hand over the other rivals in the In vivo CRO industry, the prominent players are focusing more on offering products at reasonable prices.
3. The Goal of The Report: The main objective of this research study is to provide a holistic overview and a better interpretation of market aspects to producers, suppliers, and distributors. The readers can get profound insights into this market that will allow them to formulate and develop critical strategies to bring about the desired business expansion.
4. Feature of the report:
The report studies the key factors affecting the market:
The various opportunities in the market.
To study the overall size of the market and deduce industry trends from this analysis.
To inspect the market based on the product, market share, and product share.
To analyze the market on the basis of end-users and applications focused on the growth rate of each application segment.
Reasons to Purchase In vivo CRO Market Report:
1. Current and future progression of In vivo CRO products in the developed and emerging markets.
2. The segments that are estimated to control the future growth of the In vivo CRO market.
3. Regions that are expected to undergo the fastest growth during the forecast years.
4. Identify the recent developments, In vivo CRO market shares, and lucrative strategies deployed by the prominent market contenders.
Moreover, the research report mentions the leading players in the global In vivo CRO market. Their critical marketing approaches and advertising enterprise have been underlined to offer a clear outlook of the In vivo CRO market.
In conclusion, the In vivo CRO Market report is a reliable source for accessing the Market data that will exponentially accelerate your business. The report provides the principal locale, economic scenarios with the item value, benefit, supply, limit, generation, request, Market development rate, and figure and so on. Besides, the report presents a new task SWOT analysis, speculation attainability investigation, and venture return investigation.
Find more research reports on Biotechnology Indutry, by Reports and Data:
1. Biocompatible 3D Printing Materials Market: https://www.reportsanddata.com/report-detail/biocompatible-3d-printing-materials-market
2. Cell Surface Markers Market: https://www.reportsanddata.com/report-detail/cell-surface-markers-market
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Dr. Lilly Xu joins ChemPartner as Vice President and Head of DMPK and Exploratory Toxicology
SHANGHAI, July 12, 2017 /PRNewswire/ -- Shanghai ChemPartner today announced the appointment of Lilly Xu, Ph.D. as Vice President and the Head of DMPK and Exploratory Toxicology at the company headquarters in Shanghai, China.
Dr. Xu has more than 20 years of experience in the area of drug metabolism, pharmacokinetics and toxicology. She was one of the pioneers in developing cultured human hepatocytes as a tool to study metabolism of xenobiotics and induction of P450 isozymes. Prior to joining ChemPartner, Dr. Xu was the Head of the Center of Predictive ADMET at Sanofi/Icagen. She received her Ph.D. in Cell and Molecular Biology from Saint Louis University.
Since the DMPK and Exploratory Toxicology department's inception in 2006, it has been one of the most rapidly growing business units in the company. This growth is a testament to the high-quality performance and experienced leadership by the scientific team.
"DMPK is important to Chempartner and our biopharmaceutical clients with respect to drug discovery and development to meet unmet medical needs. We needed an experienced leader to maintain the quality of service that keep our clients satisfied and coming back. Dr. Xu's expertise, knowledge, and dedication make her a great fit for the team," said Dr. Wei Tang, President of ChemPartner. Dr. Tang previously served as Senior Vice President, Biology, Biologics, and DMPK and hired Dr. Xu to lead the talented team.
"ChemPartner's DMPK Exploratory Toxicology integrated service, working in unison with our Chemistry, Biologics, and Biology departments, is the best model for helping our clients to deliver their hits, leads, and candidates in a fast and high quality manner. Our goal at ChemPartner has always been to deliver high quality data to our clients and provide scientific interpretation of the data, thereby helping to solve problems through our expertise in DMPK and toxicology," said Dr. Xu.
ChemPartner's DMPK and Exploratory Toxicology department consists of bioanalytical (small and large molecules, discovery, and regulated), in vitro ADME, in vivo pharmacokinetics, and toxicology (non-GLP and partnered GLP) groups. Working closely with Chemistry, Biology/Pharmacology, and Biologics, the department supports translational medicine with experience in formulation development, in vitro and in vivo PK extrapolation, PK/PD correlation, and biomarker analysis including metabolomics.
About ChemPartner
Shanghai ChemPartner is a full-service life science CRO with over 15 years of pharmaceutical research experience. With a team of over 2000 experienced scientists, hundreds of western-trained pharmaceutical industry leaders, and experienced pharmaceutical executive leadership at the helm, ChemPartner is aligned and dedicated to technically and strategically accomplishing the research initiatives of pharma and biotech companies worldwide.
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Read this news on PR Newswire Asia website: Dr. Lilly Xu joins ChemPartner as Vice President and Head of DMPK and Exploratory Toxicology
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Recombinant Factor fusion protein in Toxicological testings
All content on this webpage originated from other webpages,Please check the medicilon's website for details. Medicilon’s toxicology department has professional teams with rich experience in toxicology studies. We offer high-quality data and rapid turnaround period to support drug discovery and development. Our toxicological studies are conducted in various animal species. The toxicological evaluation from dose design, in-life studies to histology and pathology testing along with toxicokinetics studies are all compliant with GLP or NON-GLP standards. Our study platform is certified as one of the Shanghai Public Service Research Platforms.
Website: www.medicilon.com E-mail: [email protected]
The toxicological study effects of rFVIIIFc were measured through observations of in-life parameters (clinical observations, body weight, food consumption, and ophthalmic examination), laboratory evaluations (hematology, serum chemistry, and coagulation parameters), and post-mortem evaluation (gross necropsy, organ weights, and histopathology) in all studies. Cardiovascular evaluations were also performed for monkeys in the repeat-dose toxicology study. Electrocardiograms (ECGs) were recorded for all monkeys prior to dosing and on Day 23, as well as in the week prior to the scheduled core cohort necropsy (Day 26) and all recovery monkeys during the week prior (Day 54) to the recovery cohort necropsy; ECGs were analyzed qualitatively by a board-certified veterinary cardiologist. Heart rates were calculated from the ECG tracings. Local tolerance was evaluated through gross and microscopic evaluation of the intravenous infusion site in the repeat-dose studies in both rats and monkeys.
For the repeat-dose studies, assessments of in-life parameters, clinical pathology, and post-mortem evaluations were analyzed statistically when the number of animals was 3 or greater. Data were analyzed for effects of rFVIIIFc through an analysis of variance. For data with variances that were homogeneous across test groups, as determined by Bartlett’s test for homogeneity at the 0.05 level, tests for differences between experimental and control groups were made using Dunnett’s test. For non-homogenous data, tests for pair-wise differences between experimental and control groups were made using Cochran and Cox’s modified 2-sample t test. Statistical significance was set at the 0.05 level for all comparisons.
Rats and monkeys were pharmacologically relevant species for toxicological study, as the coagulation cascade is well conserved across species and rFVIIIFc is able to bind to FcRn in both species (unpublished data). The route of administration (intravenous) and formulations of rFVIIIFc used in this study were consistent with those used in clinical studies; the lyophilized formulation used in the repeat-dose monkey study was representative of the formulation intended for commercial use. Dosing frequency in the repeat-dose studies (every other day) was based on an elimination half-life of approximately 13 hours in both species. The doses of rFVIIIFc used in these studies (50-1000 IU/kg in the repeat-dose studies and 3000-20,000 IU/kg in the high-dose study) were greater than those indicated for use in humans.
rFVIIIFc was well tolerated in 2 relevant animal species, rats and monkeys. An adequate safety margin of 10-fold was demonstrated, based on a NOAEL of 1000 IU/kg in the repeat-dose toxicology studies compared with a highest anticipated clinical dose of 100 IU/kg. The nonclinical safety profile of rFVIIIFc shown here supported the observed clinical safety profile of rFVIIIFc [9] and. Furthermore, the A-LONG phase 3 clinical study demonstrated that rFVIIIFc was well tolerated and efficacious for the prevention and treatment of bleeding episodes in previously treated subjects with severe hemophilia.
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