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Benzoyl Peroxide - Clindamycin Phosphate - Topical Gel - RLD 50819 RV06-16 by Abdrahman Akuba is a document available to read on EtoBox.

What is Benzoyl Peroxide - Clindamycin Phosphate - Topical Gel - RLD 50819 RV06-16 about?

This draft guidance recommends conducting a bioequivalence study comparing a generic benzoyl peroxide; clindamycin phosphate topical gel to the RLD. The study should treat acne vulgaris for 12 weeks and use mean percent changes in inflammatory and non-inflammatory lesion counts from baseline to week 12 as co-primary endpoints to determine bioequivalence.

Author

Abdrahman Akuba

Language

EN