Evaluation of the proposed FDA pilot-dose response methodology for topical corticosteroid bioequivalence testing
The American FDA has recently released a Guidance document for topical corticosteroid bioequivalence testing. The purpose of this study was to evaluate the recommendations of this document for appropriateness. The new specifications require a dose-vasoconstriction response estimation by the use of a...
Main Authors: | Demana, P H, Smith, E W, Walker, Roderick, Haigh, J M, Kanfer, I |
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Format: | Others |
Language: | English |
Published: |
1997
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Online Access: | http://hdl.handle.net/10962/d1006047 |
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