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GUIDANCE DOCUMENT

CVM GFI #171 - Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products or Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media September 2019

Download the Draft Guidance Document Read the Federal Register Notice
Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-3764

Docket Number:
FDA-2019-D-3764
Issued by:
Guidance Issuing Office
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.

For further information regarding this document, contact the following individuals:

Biopharmaceutics and Pharmacokinetics:

Marilyn Martinez
Center for Veterinary Medicine (HFV-100)
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
240-402-0635
email: Marilyn.Martinez@fda.hhs.gov


Manufacturing Chemistry/Solubility Concerns:

Catherine Finnegan
Center for Veterinary Medicine (HFV-140)
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
240-402-0650
email: Catherine.Finnegan@fda.hhs.gov

Generic Drug Approval Requirements:

Ian S. Hendricks
Center for Veterinary Medicine (HFV-172)
Food and Drug Administration
7500 Standish Place
Rockville, MD 20855
240-402-0853
email: Ian.Hendricks@fda.hhs.gov