BA assessment of Spray vs topical powder [PK / PD]

posted by jag009  – NJ, 2022-04-11 20:24 (717 d 21:37 ago) – Posting: # 22929
Views: 1,225

Thanks Dshah,

We are thinking of making a spray to replace a topical powder. Its a locally acting drug with the intent to treat a specific part of the body where the infection occurs. Yes a clinical endpt study is the obvious choice, not to mention that the systemic BA is less than 1%. I was wondering if one can get by without doing a clinical endpt study though, maybe a dermal study? For a dermal study, if the location of treatment is specific, does that mean the dermal study would have to involve the same area of the skin that the treatment is applied to as per reference product label?

Thx
J

Complete thread:

UA Flag
Activity
 Admin contact
22,957 posts in 4,819 threads, 1,636 registered users;
101 visitors (0 registered, 101 guests [including 14 identified bots]).
Forum time: 17:02 CET (Europe/Vienna)

With four parameters I can fit an elephant,
and with five I can make him wiggle his trunk.    John von Neumann

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5