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FDA Study Population Requirement for BE Studies: Ethics or Science [Regulatives / Guidelines]

posted by jag009 - NJ, 2018-05-18 16:28  - Posting: # 18785
Views: 650

Hi,

» For IND and NDAs, I can understand the need for representative population. But for ANDA submissions for the registration of generics, I wonder why there is need for the use of representative population. Is it based on the need for equity (ethics) or for soundness of data (science)?

Personally I don't see this "representative population" is enforced since many ANDA (and NDA to a certain extent) studies now being conducted in India (as an example) and the study population is basically Indians. In addition, take Indian studies for example, it's very difficult (if not impossible) to get 50-50 or even 40-60 female to male ratios in a study. I have conducted studies India as well and my M/F ratios are usually 80-20 or 90-10 (sometime no females!).

I believe it's a good idea for the study population to be diverse.

John

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