Paramjeet Kaur
Food and Drug Administration, USA
Title: Biowaiver approaches for generic drug products in the US: Case studies
Biography
Biography: Paramjeet Kaur
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.