Publication of a Survey of the Regulatory Requirements for BCS-Based Biowaivers for Solid Oral Dosage Forms by Participating Regulators and Organisations of the IGDRP

  • by IGDRP - 6 February 2018 - 11:29pm

The Bioequivalence Working Group has conducted a survey of the participants’ requirements for Biopharmaceutics Classification System (BCS) based biowaivers. The BCS based biowaiver is a scientific model which enables the substitution of in vivo bioequivalence studies with in vitro data as evidence of therapeutic equivalence subject to certain conditions. Despite being based on the same principles, BCS-based biowaivers are interpreted and regulated differently among international regulatory agencies. In this survey, the Bioequivalence Working Group of the International Generic Drug Regulators Programme compared the criteria for BCS-based biowaivers applied by the participating regulators and organisations. This journal article discusses the similarities and differences amongst the various approaches, highlighting opportunities for regulatory convergence.

The article is available from the Journal of Pharmacy & Pharmaceutical Sciences