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Development of in vivo bioequivalence methodology for dermatologic corticosteroids based on pharmacodynamic modeling.

Authors
  • Singh, G J
  • Adams, W P
  • Lesko, L J
  • Shah, V P
  • Molzon, J A
  • Williams, R L
  • Pershing, L K
Type
Published Article
Journal
Clinical pharmacology and therapeutics
Publication Date
Oct 01, 1999
Volume
66
Issue
4
Pages
346–357
Identifiers
PMID: 10546918
Source
Medline
License
Unknown

Abstract

Acceptable model fits to all individual subject dose-response data were not achieved for any dermatologic corticosteroid product. However, population dose-responses were adequately described by the Emax model. On the basis of these data, the optimal dose duration used for comparison of multisource dermatologic corticosteroid products is recommended to be equal to the ED50 based on population modeling of pilot dose-response study data.

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