China Journal of Leprosy and Skin Diseases ›› 2018, Vol. 34 ›› Issue (9): 573-576.

Previous Articles    

Upate of bioavailability and bioequivalence of topical dermatological drugs

WU Lili, CHEN Yun   

  1. Department of pharmacology, Institute of Dermatology, Chinese Academy of Medical Sciences & Peking Union Medical College, Nanjing 210042, China
  • Online:2018-09-15 Published:2018-12-11
  • Contact: CHEN Yun, E-mail: sxmcysissi@163.com

Abstract: Topical dermatologic drugs take effect at the target skin and the bioequivalence study methods for orally administrated drugs may not be applicable to topical dermatologic drug. Currently, vasoconstrictor assay (VCA)has been approved by FDA, but which is only applied?to glucocorticoid drugs. The bioequivalence of other topical preparations is evaluated through clinical end-point trials. FDA is still trying to explore other methods for bioavailability, such as tape stripping, dermal microdialysis, open flow perfusion and in vitro studies. The update of above methods is reviewed in this article.

Key words: topical dermatological drug products, bioavailability, bioequivalence

CLC Number: