Bioequivalence and Bioavailability Forum

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