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GUIDANCE DOCUMENT

CVM GFI #238 Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications June 2016

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2015-N-4563
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides recommendations on the submission of chemistry, manufacturing, and controls (CMC) and pharmacokinetic information, as well as procedures to follow, to support the approval of modified release parenteral drug products intended for use in veterinary species. This information should be filed with the Center for Veterinary Medicine (CVM) to support a new animal drug application (NADA) or an abbreviated new animal drug application (ANADA).

This document provides:

  • Suggestions for development of an in vitro drug release test method
  • A discussion of the components of a drug release method
  • The role of an in vivo/in vitro correlation (IVIVC) or an in vivo/in vitro relationship (IVIVR) in a product application
  • Methods for establishing IVIVC/R for a parenteral product
  • Suggestions for establishing clinically relevant in vitro drug release specifications
  • Methods for using in vitro product specifications for setting expiry and for supporting batch release
  • Recommendations for filing information for in vitro drug release methods and data as well as material for the Pharmaceutical Development Report, and Chemistry, Manufacturing, and Controls technical section for modified-release parenteral dosage forms.

This guidance does not describe post-approval changes of in vitro methods or development of suitable correlation for oral modified release dosage forms and nanotechnology products.

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All written comments should be identified with this document's docket number: FDA-2015-N-4563.

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