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Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective
Author(s) -
MARTINEZ M.,
LANGSTON C.,
MARTIN T.,
CONNER D.
Publication year - 2002
Publication title -
journal of veterinary pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.527
H-Index - 60
eISSN - 1365-2885
pISSN - 0140-7783
DOI - 10.1046/j.1365-2885.2002.00407.x
Subject(s) - bioequivalence , perspective (graphical) , product (mathematics) , veterinary medicine , microbiology and biotechnology , medicine , pharmacology , computer science , mathematics , biology , pharmacokinetics , artificial intelligence , geometry
Martinez M., Langston C., Martin T., Conner D. Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective. J. vet. Pharmacol. Therap. 25, 201–220. The Generic Animal Drug Patent Term Restoration Act (GADPTRA) enacted in 1988 provided the same benefits to animal drug products that were granted to human generic products. It has been over 13 years since the GADPTRA was enacted, and veterinary drug sponsors and regulators have gained enormous insight and experience into some of the unique challenges associated with the determination of product bioequivalence for veterinary dosage forms. Moreover, advances in information and technology have opened both new issues that must be addressed and new mechanisms for demonstrating product bioequivalence. While many aspects of the existing Center for Veterinary Medicine Bioequivalence Guidance continue to provide invaluable guidance to the animal drug industry, there are also aspects of this guidance that are being called into question. Therefore, during the 2001 annual meeting of the American Academy of Veterinary Pharmacology and Therapeutics, participants were asked to address issues and concerns associated with the evaluation of veterinary product bioequivalence. This manuscript provides a summary of the concerns and discussions that transpired.