A contract research organization's response to the new FDA guidances for bioequivalence/bioavailability studies for orally administered drug products.
J Clin Pharmacol
; 40(10): 1102-8, 2000 Oct.
Article
em En
| MEDLINE
| ID: mdl-11028249
ABSTRACT
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.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Farmacocinética
/
Serviços Contratados
/
Avaliação de Medicamentos
Tipo de estudo:
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
J Clin Pharmacol
Ano de publicação:
2000
Tipo de documento:
Article
País de afiliação:
Estados Unidos