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

posted by jag009  – NJ, 2022-04-11 20:24 (238 d 01:56 ago) – Posting: # 22929
Views: 516

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?


Complete thread:

UA Flag
 Admin contact
22,428 posts in 4,694 threads, 1,598 registered users;
18 visitors (0 registered, 18 guests [including 15 identified bots]).
Forum time: 21:21 CET (Europe/Vienna)

Statistics is the art of never having to say you’re wrong.
Variance is what any two statisticians are at.    C.J. Bradfield

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