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: | , , , , |
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| Format: | Others |
| Language: | English |
| Published: |
1997
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| Online Access: | http://hdl.handle.net/10962/d1006047 |