#Psmf

[lifechangingtips]

Understanding "The Last Chance Diet" – A Risky Approach to Weight Loss

Exploring the Effectiveness and Risks of The Last Chance Diet “The Last Chance Diet” is an extreme weight loss program from the 1970s that was based on the concept of a protein-sparing modified fast (PSMF). Developed by Dr. Robert Linn, this controversial diet promised rapid weight loss through extreme calorie restriction, primarily using a liquid formula made from animal by-products. While it…

[alittledisordered]

124.2 lbs. 

All things considered, I’m not heartbroken. 

It’s my third week in a row of dedicated weight-lifting. I’m already feeling stronger, more energized. I’ve started alternating between eating just below my estimated TDEE on my training days, and eating a “protein sparing modified fast” on my rest days. (To keep my body from cannibalizing any of the muscle I’ve gained.)

I’m sure I’m building muscle at a slower rate than I would if I were doing a straight-up bulk... but what little I have built is already starting to peek through.

Trying on wedding dresses this month. Let’s gooo. 

[rainyfestivalsweets]

3/28/23

Some of today's meals. Plus 2 jello and a mini archer beef stick.

[kuzann]

Alright, 5k down for chapter 10 of PSMF. Valerie has had a magical time tonight and honestly she deserves it.

[k-3-volution]

Day 40 of becoming a better version of myself.

Had a wonderful day yesterday filled w lattes and a crunchy flaky pastry 🥐 skipped lunch and had Panda Express for dinner. My eye bags are still very prominent and I hit the gym yesterday still. I’m prob gonna eat whatever today again and just go meat heavy Psmf this week until Saturday. I’m a little anxious trying to not just cheat the whole weekend but my body needs rest and nourishment so being mindful and reading and thinking about myself is helping. Bc weight loss is just a facet of myself and what goals I’m striving for. Not giving up not an excuse just trying to listen to my body. I’ve also been able to sleep the past few nights so that’s welcome.

[medsurfernews]

Beginner's Guide to Protein Sparing Modified Fast (PDF)

Download Now Pages 30 Format PDF Author Adarsh Gupta, DO Genre Wellness Table of Contents Chapter 1. Introduction  Chapter 2. Understanding Protein Sparing Modified Fast (PSMF) Chapter 3. The Principles of PSMF Chapter 4. Getting Started with PSMF Chapter 5. Combining PSMF with Exercise Chapter 6. The Impact of Hydration on Metabolic Health Conclusion Key Features of This Dietary…

[superketos]

Protein-Sparing Modified Fast PSMF (Calculator + Meal Plan + 97 Foods)

[sudheervanguri]

Icon Plc, a global leader in healthcare intelligence and clinical research, is urgently hiring for the position of Pharmacovigilance Associate in Chennai. This dynamic role is pivotal in ensuring patient safety and adherence to regulatory standards. The ideal candidate should have experience in drug safety and hold a Bachelor's or Master's degree in Life Sciences. Pharmacovigilance Associate - India, Chennai Hybrid: Office/Remote About Icon Plc Icon Plc is renowned for its commitment to delivering high-quality clinical research services. With a strong focus on patient safety and regulatory compliance, we collaborate with healthcare providers and regulators globally to enhance patient outcomes. Our team is dedicated to excellence and innovation in the field of clinical research. Role and Responsibilities As a Pharmacovigilance Associate, you will play a crucial role in monitoring and ensuring the safety of medical products. Your responsibilities will include: Review and process safety events (pre-marketing, post-marketing, medical device and drug) and/or other medically related information per assigned tasks and project specific procedures Perform review of abstracts and full articles to identify safety information from literature source for both pre and post marketed products. Generates data listings from the safety database and assumes responsibility for accuracy of the data. Complete adverse event follow-up in writing and/or by phone based on requirements for each Client. Provide input and review relevant safety tracking systems for accuracy and quality and assist with maintaining project files Perform safety review of clinical and diagnostic data as part of case processing. Responsible for effective and efficient development of the Safety Management Plan, including development of specific processes to assure consistency within the project. Support creation of post-marketing safety activities, such as PSMF, RMP and PBRER Support Qualified Person for Pharmacovigilance as required. Liaise with investigational site, reporter, and/or Sponsor as necessary regarding safety issues. Liaise with ICON Medical Monitor, project manager, and other departments, as appropriate. Assist with identifying out of scope activities in conjunction with the Pharmacovigilance Project lead (as applicable) Attend project team and Sponsor meetings and teleconferences as required including presentation of the safety process at kick-off and investigator meetings. Supports the generation of Aggregated Safety Reports (e.g. Development Safety Update Report, IND Annual Report, Periodic Safety Update Reports, and other cumulative safety reports) through data retrieval and other assigned tasks. Supports interim data analysis for DMC reviews. Effectively maintains the safety database and corresponding entry guidelines, including assurance of quality of data following established quality control process. Supports creation of the SAE/AE reconciliation plan and supports SAE reconciliation in accordance with this plan and other project specific guidelines. Supports Safety Scientist in signal detection and risk management activities. Assures consistency of plans with client contract and identifies out of scope activities promptly and accurately. Proposes solutions for procedural and technical issues. Supports audits and inspections as required for the assigned projects. Perform other activities as identified and requested by management including but not limited to: Respond and process medical information inquiries including inquiries related to adverse events and product complaints for Clients’ product(s), as per their agreement with ICON. Qualifications Must-Have: Bachelor's or Master's degree in Life Sciences or a related field. Proven experience in drug safety and regulatory affairs. Strong knowledge of local and global regulatory guidelines. Excellent communication, collaboration, and problem-solving skills. Fluent in English, both written and spoken.

Proficiency in computer systems and ability to learn new applications. Nice-to-Have: Knowledge of regulatory processes and therapeutic areas. Strategic thinking with strong project management skills. [caption id="attachment_80476" align="aligncenter" width="1200"] ICON PLC Hiring Pharmacovigilance Associate[/caption] Application Process Interested candidates are invited to apply online through the Icon Plc Careers Portal. For inquiries, you can reach out to Archana Bakkiyarajan, who manages this role. Work Location Location: Chennai, India Work Type: Full-time, Hybrid (Office/Remote) Equal Opportunity Employer Icon Plc is an equal opportunity employer and complies with all applicable equal employment opportunity legislation. We encourage diversity and are committed to creating an inclusive environment for all employees.

[ihspl]

Indivirtus Healthcare Services

As a Contract Research Organization (CRO), Indivirtus Healthcare Services offers a wide range of services within the pharmaceutical and healthcare sectors. Initially, the company specialized in delivering Toxicological Risk Assessment Reports to pharmaceutical manufacturers. However, over time, it has expanded its service offerings to include numerous other services.

Established in 2018, Indivirtus Healthcare Services began its journey in a modest single-room office, staffed by just two individuals, led by Dr. Upendra Jain and Ms. Veena Kumari. Over the span of six years, this humble organization has evolved into a group of five companies, boasting seven offices worldwide and a workforce of over 100 employees. Indivirtus Healthcare Services has successfully served more than 500 clients across over 45 countries.

The range of services provided by Indivirtus Healthcare Services includes:

Toxicology:

Toxicology is the scientific field that involves the study of the harmful effects of chemicals on living organisms.

Cleaning Validation: This service ensures cleanliness to prevent contamination during production processes. It is achieved by calculating MACO (maximum allowable carryover) values based on health-based exposure limits such as PDE (Permitted Daily Exposure), ADE (Allowed Daily Exposure), and OEL (Occupational Exposure Limit), all established through thorough risk assessments. These reports adhere to guidelines set by EMA, ICH, APIC, AND PICS.

Genotoxic Evaluations of Impurities: Utilizing ICH M7 guidelines, this service assesses the genotoxicity and mutagenicity of impurities to determine their acceptability in drug substances and products.

Material Safety Data Sheets (MSDS): These provide detailed information on the safety and handling of materials.

GRAS Reports: These confirm the safety of substances for their intended use.

Regulatory Affairs/Regulatory Affairs (RA/Reg Affairs)

Preparation and Submission of CTD, ACTD & e-CTD Dossiers

Dossiers for Regulated, Semi-regulated, and WHO Regulated Market

CEP Filing & Submission on the EDQM Portal and DMF Filing to the FDA

Clinical & Non-Clinical Overviews and Summaries

Batch Releasing & Testing Site Service for Europe (BRS & BTS)

MAH & Local Agent Service for Europe & US

Pharmacovigilance and Drug Safety Services

PSMF Management

Single Case and Adverse Event Reporting

Aggregate Report Generation

Safety Physicians Support

Signal Management & Safety Surveillance

Literature Monitoring (Global and Local)

Medical Writing

Risk Management Plans (RMPs)

Electronic Submission Management

Medical Information Call Centre (MICC)

Qualified Person for Pharmacovigilance (QPPV) Support

Regulatory Authority Requests and Audit/Inspection Readiness

Social Media Monitoring for Adverse Events

Calibration Services

Indivirtus Healthcare Services is equipped to provide a variety of calibration services through a facility accredited by NABL (National Accreditation Board for Testing and Calibration Laboratories) (ISO/IEC: 17025:2017). Our calibration services cover a broad spectrum, including:

Calibration Facility in various dimensions, pressure, mass, volume, RPM, sound, electro-technical, and thermal.

Temperature Mapping and Validation Facility for Furnace, Chambers, Oven, and Cold Storage.

On-site Facility for Calibration.

Training on Quality Systems & Implementation.

Computerized System Validation (CSV)

Indivirtus Healthcare Services is dedicated to providing comprehensive services in CSV to ensure that systems are performing their intended tasks effectively. Our CSV services include:

Implementation and Validation of Computerized Systems.

Decommissioning of Computerized Systems.

Cloud Systems Validation.

Quality Systems for IT Departments and IT Service Suppliers.

Quality Systems for Software Validation.

Computer Infrastructure Qualification.

Audits for IT Solution Suppliers.

Training.

Clinical Research & Equivalence Studies

Indivirtus Healthcare Services provides a range of clinical research services, including feasibility assessments, participation in regulatory discussions, project oversight, management of clinical sites, handling of data and statistical analysis, and the conduct of Phase I, II, III clinical studies.

Technology Transfer (Tech Transfer)

Indivirtus Healthcare Services specializes in technology transfer services, facilitating the transition of drug substance production processes from research laboratories to commercial facilities. Our services include CMO (Commercial Manufacturing) site transfers and CMDO (Research and Development to Commercialization) services. We handle various aspects of technology transfer, such as:

Site transfers

Research and Development/Funding and Development

Dossiers/Know-how

Good Manufacturing Practices (GxP) and Auditing Services

Indivirtus Healthcare Services offers a variety of audit services to help identify and address deficiencies in processes, ensuring compliance. Our audit services include:

Internal audits and Good, Environment, Management, and Business Analysis (GEMBA) sessions

Third-party audits and Gap assessments

Pre-inspection and Due Diligence audits

Additional Services Provided by Indivirtus Healthcare Services include:

CMO/CDMO Facilities for the Sourcing of Formulations and Active Pharmaceutical Ingredients (APIs)

Greenfield/Brownfield Development Projects

[pharmacoviligiance]

Pharmacovigiance

introduction

Pharmacovigilance, the science and activities related to the detection, assessment, understanding, and prevention of adverse drug reactions (ADRs) or any other drug-related problems, is crucial in ensuring drug safety. In the Commonwealth of Independent States (CIS), robust pharmacovigilance services are essential to facilitate drug monitoring and regulatory compliance. This article explores key aspects of pharmacovigilance services in CIS countries, with a particular focus on the role of service providers such as PharmExpert LLC.

Role of Pharmacovigilance in Drug Safety

Pharmacovigilance services support drug safety by systematically collecting data on adverse events and ADRs to improve the benefits-to-risk ratio of pharmaceuticals. In the CIS region, the regulatory environment is evolving, and adherence to Good Pharmacovigilance Practices (GVP) is imperative for pharmaceutical companies. These practices ensure that all safety data are accurately captured and reported in compliance with local regulations.

Literature Screening and Local Monitoring

An essential aspect of pharmacovigilance is literature screening, which involves the collection and analysis of relevant scientific literature for potential safety issues related to pharmaceutical products. Local literature monitoring ensures that ongoing research and publications specific to the CIS region are consistently reviewed. This is essential for timely identification of new safety signals.

Qualified Person for Pharmacovigilance (QPPV)

In CIS countries, having a Qualified Person for Pharmacovigilance (QPPV) is a regulatory requirement. The QPPV is responsible for the pharmacovigilance system within an organization, ensuring compliance with local laws and guidelines. They play a critical role in the oversight of the Pharmacovigilance System Master File (PSMF), which contains comprehensive information about the safety profile of a drug.

Local Contact Person for Pharmacovigilance (LCPPV) and Local Person for Pharmacovigilance (LPPV)

The Local Contact Person for Pharmacovigilance (LCPPV) and Local Person for Pharmacovigilance (LPPV) also play vital roles. The LCPPV serves as a liaison between regulatory authorities and pharmaceutical companies, enabling effective communication and timely reporting of safety information. Meanwhile, the LPPV ensures that safety reports, such as Individual Case Safety Reports (ICSRs), are accurately prepared and submitted.

Safety Reporting Mechanisms

Adverse event reporting is a critical function of pharmacovigilance. It involves capturing all potential ADRs associated with pharmaceuticals. Regularly compiled safety-related reports, including the Periodic Safety Update Report (PSUR) and Development Safety Update Report (DSUR), provide regulatory authorities with ongoing assessments of drug safety over time.

Risk Management Plan (RMP) and Safety Alerts

Risk Management Plans (RMPs) are developed to mitigate risks associated with pharmaceutical products. They outline the strategies in place to monitor safety and communicate any necessary safety alerts to healthcare professionals and the public. Rapid dissemination of safety information is vital for maintaining trust in medication and protecting public health.

Regulatory Intelligence

Staying abreast of regulatory changes and trends is essential for pharmaceutical companies operating in the CIS region. Regulatory intelligence helps organizations navigate the complexities of local and international laws affecting pharmacovigilance practices. This proactive approach ensures compliance while also optimizing safety reporting processes.

Role of PharmExpert LLC

PharmExpert LLC is a notable pharmacovigilance service provider within the CIS countries. The company offers comprehensive services, including literature screening, local literature monitoring, and the provision of qualified personnel for pharmacovigilance. Their expertise is instrumental in helping pharmaceutical companies comply with local regulations and maintain high standards of drug safety.

Conclusion

Pharmacovigilance services in CIS countries are pivotal in safeguarding public health by ensuring drug safety. Understanding and implementing GVP, timely reporting of adverse events, and the establishment of qualified personnel such as QPPVs and LCPPVs are crucial for effective pharmacovigilance. As the regulatory landscape continues to evolve, services provided by organizations like PharmExpert LLC will remain essential in supporting pharmaceutical companies to navigate the complexities of drug safety management.

[karajage]

QPPV and PSMF

Our team comprises 40 EU/UK Qualified Persons for Pharmacovigilance (QPPV) along with their deputies, alongside over 95 local contact persons responsible for PV (LCPPV). Together, they offer comprehensive assistance in establishing and managing intricate global PV systems and engaging in non-routine PV activities. With decades of industry experience and profound knowledge of industry trends and regulations, our experts deliver unparalleled expertise.

Our QPPVs offer not only oversight but also general pharmacovigilance consultancy, providing effective guidance on additional PV and risk management activities throughout your product’s lifecycle. PrimeVigilance excels in Pharmacovigilance System Master File (PSMF) and PV Safety Data Exchange Agreements (SDEA) authoring, optimization, and management, ensuring streamlined negotiations and compliance with PV Agreements (PVAs).

Throughout all phases of the PVA process—pre-PVA, creation, implementation, and maintenance/termination—our experts offer invaluable assistance, crafting practical SDEAs/PVAs and monitoring compliance to facilitate effective stakeholder negotiations and prompt amendments.

We meticulously review pharmacovigilance agreements for drug-device combination (DDC) products with suppliers, ensuring thorough consideration of additional data requirements such as device malfunctions and device-related events.

Our seasoned EU QPPVs and technical experts are adept at developing and maintaining inspection-ready PSMFs associated with authorized medicinal products, while also ensuring adherence to specific regional requirements. In Europe, any changes to the summary of PV systems or PSMFs are promptly communicated through our dedicated resources via the Article 57 database (XEVMPD).

[lifechangingtips]

Weight Loss, Weight Maintenance: Keto, Carnivore, PSMF & Fasting - Robert Sikes @ketosavage

Check on YouTube

[alittledisordered]

I know. Lighting and high-waisted pants can make a world of difference for us pear-shaped girls.

Wednesday Weigh-in: 128.3 lbs.

And I am looking pretty lean, I think? Definitely stronger and more toned than I was a few months ago.

I look healthy.

I've been really on track, lately. Low calories. High protein. None of that crazy "PSMF" stuff, but enough calories to maintain a reasonable energy level- and enough protein to protect the muscle I've put on.

Yay.

[rainyfestivalsweets]

3/26/23

Meal prep. Egg bake, boiled cauli, chicken breast for the freezer.

The fridge is stuffed with veggies & good food.

Ready together after it again.

Trying to alternate keto-ish days with psmf-ish days.

I have workouts scheduled.

[kuzann]

I'm going to have to read through PSMF again to make sure things are cohesive aren't I? orz That's going to take a while...

It'll be nice to get back on track, though.

[k-3-volution]

Day 68 of becoming a better version of myself.

Didn’t take a pic yesterday. I’ve really relaxed on the weekends and occasions and stuff and that’s okay? I think lol still figuring out how I feel. I’m trying to up my mileage running I ran 5 miles in a little over an hour Saturday without stopping (jog, very slow) but I’m nevertheless proud of myself. I did keep up my fasting routine this weekend and did activity that felt fun and good for my body. When I have been eating I’m not gorging myself and I can have a little of something like my candy or a cookie and not eat the entire box which is something I haven’t felt in control of since literally middle school or younger. Might get into more fasting/psmf/dieting w this new job cuz I still got this fat to lose and it’ll be interesting the way running/working more will effect it.