CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Containing Active Pharmaceutical Ingredients Considered to Be Soluble in Aqueous Media June 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-2019-D-3764
• Issued by: Center for Veterinary Medicine

This document describes how the Center for Veterinary Medicine (CVM) intends to evaluate requests for waiving the requirement for performing in vivo bioequivalence studies (biowaivers) for animal drugs administered orally as soluble powders or as Type A medicated articles manufactured from active pharmaceutical ingredients (APIs) considered to be soluble in aqueous media (water soluble APIs). This document expands upon CVM’s Guidance for Industry (GFI) #35, “Bioequivalence Guidance,” to include biowaivers for soluble powder oral dosage form products as well as Type A medicated articles manufactured from active pharmaceutical ingredients considered to be soluble in aqueous media, and it offers particular focus on criteria for the waiver of the requirements for submitting in vivo bioequivalence study data.  This guidance does not address Type A medicated articles manufactured from active pharmaceutical ingredients considered to be insoluble in aqueous media.

 

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