Welcome to the third edition of Biosimilars Newsletter, a quarterly publication dedicated to keeping you updated on current biosimilars news, including the global regulatory landscape, biosimilars articles and reports and company news as reported via company press releases. The “hot topic” for this edition focuses on the essential role which pharmacovigilance plays in the development of a biosimilar product and in particular the need for strategic planning of post-marketing surveillance activities and the role of observational prospective cohort studies.
Phase I healthy volunteer studies play a vital role in clinical research by providing researchers with the knowledge they need to make educated…
LC-MS/MS Support for Studies with Large Molecules
PRA’s Bioanalytical Laboratories provide LC-MS/MS services to support clients’ studies with biological and small molecules. The information details…