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...

Full description

Bibliographic Details
Main Authors: Demana, P H, Smith, E W, Walker, Roderick, Haigh, J M, Kanfer, I
Format: Others
Language:English
Published: 1997
Online Access:http://hdl.handle.net/10962/d1006047