#Biosimilarsstudiesexperience

[lambdatherapeutic]

Impact of Immunogenicity on the Pharmacokinetics and Pharmacodynamics of Biosimilars

Due to An increasing utilization and approvals of biosimilars, immunogenicity has become a significant concern which needs to be assessed due to its potential impact on the efficacy and safety of the molecule. With the use of biological products, individuals sometimes tend to develop immunogenicity, due to which the body's immune system produces anti-drug antibodies (ADA), which further bind to various epitopes of the circulating molecule, varying its effects in terms of pharmacokinetics and/or efficacy or safety of the molecule.

https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=106

[lambdatherapeutic]

Simpler, Swifter & Smarter In-vitro Methods for Bioequivalence Studies, Decoded

A simple, precise, and accurate, reverse-phase, ultra-performance liquid chromatography tandem mass spectrometric bioanalytical method was developed for the quantitative determination of bile acids [glycocholic acid (GCA), glycochenodeoxycholic acid (GCDA), and taurodeoxycholic acid (TDCA)] in an in-vitro bile acid-binding study of Colesevelam HCl tablets.

 The separation was achieved using a Poroshell EC C18 2.7µm 4.6 x 100mm column with a mobile phase containing solvent A consisting of methanol and solvent B consisting of 2mM Ammonium formate buffer (80:20) with a total run time of 6.0 minutes.  

https://www.lambda-cro.com/blog-detail-page.php?blogDetailId=104