Revisiting FDA’s 1995 Guidance on Bioequivalence Establishment of Topical Dermatologic Corticosteroids: New Research Based Recommendations
Purpose: As per the US FDA guidance issued on June 2, 1995, the establishment of bioequivalence for topical dermatologic corticosteroids is based on comparing the pharmacodynamic (PD) effects of Test and Reference products at the dose duration corresponding to the population ED50, determined either...
Main Authors: | Deniz Ozdin, Naveen Sharma, Jorge Lujan-Zilbermann, Philippe Colucci, Isadore Kanfer, Murray P. Ducharme |
---|---|
Format: | Article |
Language: | English |
Published: |
Canadian Society for Pharmaceutical Sciences
2018-11-01
|
Series: | Journal of Pharmacy & Pharmaceutical Sciences |
Online Access: | https://journals.library.ualberta.ca/jpps/index.php/JPPS/article/view/30021 |
Similar Items
-
Evaluation of the proposed FDA pilot-dose response methodology for topical corticosteroid bioequivalence testing
by: Demana, P H, et al.
Published: (1997) -
The FDA’s Regulatory Framework for Chimeric Antigen Receptor‐T Cell Therapies
by: Peter Marks
Published: (2019-09-01) -
FDA’s Strategies to Close the Health Equity Gap among Diverse Populations
by: Jovonni Spinner, et al.
Published: (2021-03-01) -
FDA’s new pharmaceutical quality initiative: Knowledge-aided assessment & structured applications
by: Lawrence X. Yu, et al.
Published: (2019-12-01) -
Registries, research, and regrets: is the FDA’s post-marketing REMS process not adequately protecting patients?
by: Norman J. Kachuck
Published: (2011-11-01)