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ICH (USFDA) Guidance: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

The USFDA released draft guidance for the industry on January 31, 2023, “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”.

This guideline provides recommendations for conducting bioequivalence (BE) studies during the development and post-approval phases for solid oral dosage forms, such as tablets, capsules, and granules/powders, intended for the systemic delivery of drugs.

BE assessment for these oral dosage forms is important for establishing therapeutic equivalence for generic drug products to their respective comparator products.

This is the first guidance developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) on harmonizing BE standards for generic drugs following the publication of the ICH reflection paper, "Further Opportunities for Harmonizing Standards for Generic Drugs" (November 2018).

  1. In M13A, the scientific and technical aspects of study design and data analysis are described to support BE assessment for orally administered IR solid oral dosage forms or oral suspensions.

  2. M13B discusses the biowaiver considerations pertaining to additional strengths that have not been researched in BE studies.

  3. M13C, will include data analysis and BE assessment for highly variable drugs, drugs with narrow therapeutic index, and complex BE study design and data analysis considerations.

The acceptance of comparator products across regulatory jurisdictions may reduce the burden of demonstrating BE against local comparator products across multiple regions. However, in some regions, local laws govern this rather than scientific guidelines.

Click this LINK to know in detail about Bioequivalence Criteria, & the general principles involved in establishing bioequivalence.


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