Principles and criteria in the development and optimization of topical therapeutic products.
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.
Shah
V P
VP
Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20857.
Behl
C R
CR
Flynn
G L
GL
Higuchi
W I
WI
Schaefer
H
H
D000287:Administration, Topical; D000818:Animals; D002626:Chemistry, Pharmaceutical; D004358:Drug Therapy / Q000379:methods; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D012867:Skin / Q000187:drug effects / Q000378:metabolism*
D004364:Pharmaceutical Preparations