jag009
★★★

NJ,
2022-04-07 18:37
(49 d 02:02 ago)

Posting: # 22916
Views: 401
 

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

Hi all,

Does anyone have experience dealing with assessing BA (or BE) between a topical spray and a topical powder in a study?

Thx
j
dshah
★    

India/United Kingdom,
2022-04-08 07:58
(48 d 12:41 ago)

@ jag009
Posting: # 22917
Views: 325
 

 BA assessment of Spray vs topical powder

Hi John!
It seems that drug is for local action and many times clinical endpoint is recommended. Can we have more info?
Regards,
Divyen
jag009
★★★

NJ,
2022-04-11 18:24
(45 d 02:15 ago)

@ dshah
Posting: # 22929
Views: 284
 

 BA assessment of Spray vs topical powder

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
Evylffcod
☆    

NYC USA,
2022-04-27 16:27
(29 d 04:11 ago)

@ jag009
Posting: # 22941
Views: 147
 

 BA assessment of Spray vs topical powder

interesting information
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