Document Detail


Challenges associated with the evaluation of veterinary product bioequivalence: an AAVPT perspective.
MedLine Citation:
PMID:  12081616     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
M Martinez; C Langston; T Martin; D Conner
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of veterinary pharmacology and therapeutics     Volume:  25     ISSN:  0140-7783     ISO Abbreviation:  J. Vet. Pharmacol. Ther.     Publication Date:  2002 Jun 
Date Detail:
Created Date:  2002-06-25     Completed Date:  2002-09-19     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7910920     Medline TA:  J Vet Pharmacol Ther     Country:  England    
Other Details:
Languages:  eng     Pagination:  201-20     Citation Subset:  IM    
Affiliation:
Center for Veterinary Medicine, Food and Drug Administration, Rockville, MD 20855, USA. mmartin1@cvm.fda.gov
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MeSH Terms
Descriptor/Qualifier:
Animals
Drug Approval
Drug Industry / standards*
Evaluation Studies as Topic
Legislation, Drug
Practice Guidelines as Topic
Therapeutic Equivalency*
United States
Veterinary Drugs / pharmacokinetics*
Chemical
Reg. No./Substance:
0/Veterinary Drugs

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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