Title:The Gradually Expanding Scope for Biowaivers of Oral Products: An Overview
Volume: 22
Issue: 42
Author(s): Vikrant Saluja, Amanpreet Singh and Adnan M. Algradi
Affiliation:
Keywords:
Biowaiver, Bioequivalence, BCS, IVIVC, SUPAC.
Abstract: The regulatory paradigm is relaxing gradually without compromising the safety, efficacy and the quality
of the drug product and, most importantly, a perceptible scientific consensus is maturing towards the need of
affordable medicines. The establishment of bioequivalence (BE) is no longer being considered to be accomplished
only by in vivo studies in oral drug products. The potential use of in vitro dissolution testing in lieu of BE
studies has now been regulatory adopted and is commonly referred to as “biowaiver”. Further, the advent of biopharmaceutics
classification system (BCS) and in vitro-in vivo correlation (IVIVC) proves to be sound milestones
and signifies that we are incessantly forwarding towards a scenario that would reduce regulatory burden, save
time and make the drug products more affordable while ensuring their quality. This review outlines, the current
and pertinent regulatory environment for biowaiver based on in vitro drug dissolution, primarily as per the FDA
perspective. The rationale used for qualification of biowaiver for different strengths, post-approval changes and
multi-source products are discussed along with the role of BCS and IVIVC.