Paramjeet Kaur
Food and Drug Administration, USA
Biography
Paramjeet Kaur is a Senior Reviewer at the Division of Bioequivalence II, Office of Generic Drugs, CDER, FDA. She reviews the bioequivalence studies, in vitro dissolution data, and bioanalytical method validations submitted in support of approval of generic drug applications. She has also written several bioequivalence study design recommendations for specific drug products. She received her Bachelor in Pharmacy from the Banaras Hindu University, India, and Doctorate in Industrial Pharmacy from St. John’s University, USA. Her current research interests include pharmacokinetics, use of pharmacokinetic modeling and simulation to predict bioequivalence, and in-vitro in-vivo correlations.
Abstract
Abstract : Biowaiver approaches for generic drug products in the US: Case studies