Document Detail


A contract research organization's response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products.
MedLine Citation:
PMID:  11028249     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The new FDA Guidance for Industry BA and BE Studies for Orally Administered Drug Products--General Considerations and Average, Population, and Individual Approaches to Establishing Bioequivalence imply significant changes in the areas of enrollment, cost, ethics, time, entry, validation applications (EVAs), and statistical and pharmacokinetic methods. The changes from three-period to two-period design for food effect studies, the elimination of most steady state studies, and the analyses of only the active moiety or ingredient are welcome. However, if the current guidances are adopted, additional time will be needed for participants, and more participants will be needed, resulting in higher costs to drug developers. The PK parameters needed to assess BE and the need for replicate designs for drugs with long t1/2 are still unclear. Finally, the advantages of the aggregate property of the FDA metric versus the disaggregate criteria are challenged, and four bioequivalence criteria are proposed.
Authors:
E Kimanani; D Stypinski; G Curtis; M Stiles; P Heessels; S Logan; K Nelson; E St Germain; G Boswell
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Journal of clinical pharmacology     Volume:  40     ISSN:  0091-2700     ISO Abbreviation:  J Clin Pharmacol     Publication Date:  2000 Oct 
Date Detail:
Created Date:  2001-01-16     Completed Date:  2001-02-01     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0366372     Medline TA:  J Clin Pharmacol     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  1102-8     Citation Subset:  IM    
Affiliation:
MDS Pharma Services, Lincoln, Nebraska, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Oral
Contract Services / organization & administration*
Data Interpretation, Statistical
Drug Evaluation / economics,  legislation & jurisprudence,  methods,  standards*
Drug Industry
Humans
Pharmacokinetics*
Research Design
Time Factors
United States
United States Food and Drug Administration / legislation & jurisprudence*

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


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