BioAnalytical Laboratories White Papers & Case Studies

1. Bioanalysis Of Biosimilars 8/5/2015

   Assessment of biosimilarity during non-clinical and clinical trials requires specific bioanalytical procedures. The concentration of the biosimilars and their reference compounds is established using pharmacokinetic (PK) methods. By BARRY van der STRATE, PhD, Associate Director of Science, Large Molecules, PRA Health Sciences; CHAD BRISCOE, PhD Executive Director of Science & Innovation Bioanalytical Services, PRA Health Sciences

2. Human ADME & Studies With Radiolabeled Compounds

   During clinical drug development there can be several situations where the use of radiolabeled medication or other radiolabeled compounds is required or favorable to accomplish the study objectives. This whitepaper is mainly focusing on human ADME studies and “microdose” studies to assess absolute bioavailability (BA). The major part of the information in this overview is also relevant for other clinical studies with a radiolabeled compound. By Ad Roffel and Henk Poelman, PRA Health Sciences