Ethics (?) masquerading as Science [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2018-05-15 20:16  – Posting: # 18766
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Hi Scopy,

» 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)?

IMHO, the former masquerading as the latter. See this post.

Cheers,
Helmut Schütz
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