Vet Drug Guidance

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] FDA has released for comment a draft guidance on “Modified Release Veterinary Parenteral Dosage Forms: Development, Evaluation, and Establishment of Specifications.”  The draft provides recommendations for what CMC and pharmacokinetic information is required for the approval of the products.  Included are recommendations regarding: ● development of an in vitro drug release test method ● 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 ● establishing clinically relevant in vitro drug release specifications ● methods for using in vitro product specifications for setting expiry and for supporting batch release, and ● filing information for in vitro drug release methods and data as well as material for the Pharmaceutical Development Report, and the CMC technical section for modified-release parenteral dosage forms.  Comments are due by March 19.
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