Journal of Bioequivalence & Bioavailability

Biowaiver approaches for generic drug products in the US: Case studies

6^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit

August 17-19, 2015 Chicago, USA

Paramjeet Kaur

Keynote: J Bioequiv Availab

Abstract:

The bioequivalence (BE) evaluation is a critical component of the Abbreviated New Drug Application (ANDA) review
process. For systemically acting generic oral dosage forms, the BE is often demonstrated through in vivo pharmacokinetic
studies by comparing the rate and extent of absorption of active ingredient or moeity from generic drug product with that of
the corresponding reference listed drug product. Per criteria set forth in 21 CFR § 320.22, the United States Food and Drug
Administration (U.S. FDA) may grant waiver of in vivo BE study requirements (biowaiver) for generic drug products, if in vivo
bioavailability or bioequivalence of the drug product is self-evident. The biowaivers may also be granted for solid oral dosages
and other dosage forms administered via a different route of administration (e.g. azacitidine injectable suspension, acyclovir
topical ointment), using in vitro tests to assess bioequivlaence. This presentation will discuss about recently implemented in
vitro BE approaches for different dosage forms, waiver of in vivo BE studies for non biostudy strengths, and biowaivers in the
presence of an established in-vitro in-vivo correlation (IVIVC) along with the case studies from ANDA submissions.

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.