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Principles and criteria in the development and optimization of topical therapeutic products
V P Shah1, C R Behl, G L Flynn
1Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857.
Skin Pharmacology : the Official Journal of the Skin Pharmacology Society
|January 1, 1993
Abstract:
The report differentiates between dermatological and transdermal products, identifies and discusses the principles involved in the development and optimization of topical drug products. The regulatory concerns in the evaluation of topical dermatological products with respect to bioequivalence and quality control are also discussed.