USP proposes additional changes to <1090> Assessment of Drug Product Performance

Recommendation

27-29 February 2024

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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:

• contains a compilation of resource documents on dosage form performance available from the U.S. Food and Drug Administration (FDA) and the World Health Organization (WHO) along with the source information;
• contrasts the biowaiver approaches and terminology used by the FDA and WHO. One of its purposes was that chapter <1090> serves as a summary resource for the reader compiling titles and sources of available regulatory guidance documents.

The PF 42(4) proposal included:

• Chapter title change (ASSESSMENT of SOLID ORAL DRUG PRODUCT PERFORMANCE and INTERCHANGEABILITY, BIOAVAILABILITY, BIOEQUIVALENCE, and DISSOLUTION) in recognition that the content of <1090> was most relevant to solid oral drug products,
• Chapter title change in recognition of the inclusion of interchangeability information,
• Inclusion of a discussion of factors affecting solid oral drug product interchangeability,
• Incorporation of definitions, biowaiver approaches, and reference sources from the European Medicines Agency (EMA),
• Updated reference information and other text.

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:

• Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs,
• Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.

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.

After registration to the Pharmarcopoeial Forum you get access to the complete stimuli article.