(16 d 19:59 ago)
(edited by on 2023-03-08 11:11)
Posting: # 23491
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?
Edit: Category changed; see also this post #1. Are you really located in Japan? [Helmut]