15/16 September 2020
In a stimuli article published in Pharmacopeial Forum (PF) 43(5) [Sept.–Oct. 2017], the United States Pharmacopeia (USP) proposes additional changes to general chapter <1090> Assessment of Drug Product Performance—Bioavailability, Bioequivalence, and Dissolution.
The chapter was previously proposed for revision in PF 42(4) [July–Aug. 2016]. The revision proposal includes several important changes to the chapter content that originally became official in the Second Supplement to USP 32–NF 27 (December 2009). The current official chapter provides discussion on approaches used to evaluate dosage form performance in the context of bioavailability.
However, the current official chapter:
The PF 42(4) proposal included:
According to the comments received there are a number of issues within the revised chapter including concerns associated with two new FDA draft guidances issued in 2015:
The USP says that "these guidances, although published in draft form, promise significant changes to the U.S. regulatory biowaiver approaches as well as new advice on developing dissolution tests for immediate-release products based on the Biopharmaceutics Classification System (BCS)". Additionally, the USP General Chapters—Dosage Forms Expert Committee (GCDF EC) "is aware that the WHO has updated its multisource (generic) pharmaceutical products guidelines to remove specific BCS Class 2 drugs from biowaiver consideration".
Therefore, the GCDF EC has decided to present a new proposal to <1090> once more in PF. "The proposed revision will include up-to-date information from two new FDA guidances and WHO guidelines regarding biowaivers. The PF publication will be timed to occur as soon as practical after the FDA issues the two FDA guidances in their final form." Recently, the final version of FDA´s guidance on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System has been published on FDA´s website.
In Addition, the International Council for Harmonisation (ICH) recently informed about developing a new guideline, M9: Biopharmaceutics Classification System (BCS)-based Biowaivers, providing recommendations to support the biopharmaceutics classification of medicinal products.
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