Author: [AUTHOR] Published on 11/15/2024 12:00:00 AM
FDA Announces the Availability of the Guidance for Industry M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms and Revised PSGs
On October 31, 2024, the US Food and Drug Administration (FDA) published the guidance for industry, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms,” which provides recommendations for conducting bioequivalence (BE) studies during development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension. This guidance finalizes the draft version published in January 2023. To facilitate implementation of the guidance, a supplemental questions and answers document was published to clarify concepts and rationales covered in the guidance.
In addition, FDA revised 814 draft Product-Specific Guidances (PSGs) for a subset of immediate-release oral drug products. The revised PSGs recommend that ANDA applicants conduct one BE study for products with a non-high risk of bioinequivalence due to food effect, under either fasting or fed conditions, rather than conducting two BE studies, one BE under fasting conditions and one BE study under fed conditions. Other revisions, including a Biopharmaceutics Classification System (BCS)-based biowaiver option and additional editorial revisions, are incorporated as appropriate. For a full list of the revised draft PSGs, please refer to the Federal Register Notice.
BE for IR solid oral dosage forms with systemic action is largely established via clinical pharmacokinetic (PK) BE studies or comparative in vitro dissolution studies. BE assessment for these oral dosage forms is important for establishing therapeutic equivalence for generic drug products to their respective comparator products. Demonstration of BE may be critical for approval decisions in certain new (innovator) drug development situations and BE studies are also used by innovator and generic product developers for supporting post-approval formulation and/or manufacturing process changes.
This guidance (M13A) was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) by the ICH M13 Expert Working Group. The PSGs revisions align the recommendations with those in the M13A guidance and will significantly reduce the numbers of BE studies needed for these immediate-release oral drug products. The guidance, the first ICH guidance for BE, is intended to provide harmonized, global, scientific recommendations for conducting BE studies during both development and post-approval phases that can increase the efficiency of drug development and improve the availability of safe and effective orally administered IR solid oral dosage forms globally.
Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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