Overview:
Drug substances and novel excipients are measured in many sample types; this includes blood, plasma, serum, and tissues to track resorption and elimination. This paper will review optimization of sample preparation and liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS) methods, which are crucial for bioanalytical method development. The overall objective is the development of a robust method of assessing absorption capacity, bioavailability, and biodistribution of drug substances and novel excipients before validation.
Key Learning Objectives:
Author:
Uday Velagapudi, Ph.D.
Scientist III/ Group Leader
Uday Velagapudi is a Scientist III/Group Leader of Pharmaceutical Sciences at Pace® Life Sciences, an integrated CMC drug product development CRO. Uday is an SME focusing on method development for bioanalytical quantitation, small molecule and metabolite characterization, protein characterization and host-cell protein analysis using low and high-resolution LC-MS systems. Uday is the author or co-author of eight publications in reputable journals such as Science and Journal of medicinal chemistry and received his PhD in Medicinal and Pharmaceutical Chemistry from St. John’s University, NY.