Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective.
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.
Martinez
M
M
Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA. mmartin1@cvm.fda.gov
Langston
C
C
Martin
T
T
Conner
D
D
D000818:Animals; D017277:Drug Approval; D004345:Drug Industry / Q000592:standards*; D005069:Evaluation Studies as Topic; D007880:Legislation, Drug; D017410:Practice Guidelines as Topic; D013810:Therapeutic Equivalency; D014481:United States; D019155:Veterinary Drugs / Q000493:pharmacokinetics*
D019155:Veterinary Drugs