HallaGulla
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2023-03-08 09:58
(16 d 19:59 ago)

(edited by on 2023-03-08 11:11)
Posting: # 23491
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 EU Transdermal Patch: Generic Submission [Design Issues]

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Hi All

One of the clients with whom I am working is developing a generic transdermal patch for UK/EU submission.

They are asking us to do the PK study, Adhesion study and skin senstization study in either EU/UK or in USA due to simialr climatic condition.

My question is, can these studies be done in India or any other countries? Does MHRA/EMA accepts transdermal studies done in the geographies which has a different climatic conditions?


TIA...

Edit: Category changed; see also this post #1. Are you really located in Japan? ;-) [Helmut]

:lol: Shhhhh
 
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