Description
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.
Scope & Applicability
Product Classes
5Animal drugs administered orally via drinking water
Unpurified fermentation product derived from microorganisms.
New animal drug dosage forms intended for use in the manufacture of medicated feeds; The primary product category discussed for CMC considerations.; manufactured for homogeneity, segregation, and stability studies
The primary product category covered by this guidance; Subject of the bioequivalence guidance for poorly soluble APIs.
Dosage form eligible for biowaivers if API is water soluble
Stakeholders
1Entity responsible for submitting applications under section 524B
Regulatory Context
Attributes
3Property used in the decision tree for in-vitro testing
Time parameter used to determine the period of shaking in solubility studies.
The rate and extent to which the API is absorbed and becomes available at the site of action
Related CFR Sections (4)
- 21CFR514.1§ 514.1 Applications.
(a) Applications to be filed under section 512(b) of the act shall be submitted in the form and contain the information described in paragraph (b) of this section, as appropriate to support the particular submission. If any part of the application is in a foreign language, an accurate and complete ERead full regulation →
- 21CFR320.1§ 320.1 Definitions.
The definitions contained in § 314.3 of this chapter apply to those terms when used in this part.Read full regulation →
- 21CFR320.21§ 320.21 Requirements for submission of bioavailability and bioequivalence data.
(a) Any person submitting a full new drug application to the Food and Drug Administration (FDA) shall include in the application either:Read full regulation →
- 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
(a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →
See Also (8)
- CVM GFI #137 Analytical Methods Description for Type C Medicated Feeds (Status: Final)
- Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use: Guidance for Industry (Status: Final)
- Final In Vivo Bioavailability-Bioequivalence Studies- Analytical (Status: Final)
- Topical Dermatologic Corticosteroids: in Vivo Bioequivalence (Status: Final)
- Bioresearch Monitoring Technical Conformance Guide (Status: Final)
- Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (Status: Draft)
- Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of Human Immunodeficiency Virus-One Under the President’s Emergency Plan for Acquired Immunodeficiency Syndrome Relief (Status: Draft)
- Statistical Approaches to Establishing Bioequivalence (Status: Draft)