Bioequivalence and Bioavailability Forum • Ethics (?) masquerading as Science

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

posted by Helmut – Vienna, Austria, 2018-05-15 22:16 (2169 d 17:06 ago) – Posting: # 18766
Views: 2,231

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.

—
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Helmut Schütz

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Complete thread:

FDA Study Population Requirement for BE Studies: Ethics or Science Obinoscopy 2018-05-15 19:31 [Regulatives / Guidelines]
- Ethics (?) masquerading as ScienceHelmut 2018-05-15 20:16
- FDA Study Population Requirement for BE Studies: Ethics or Science bebac_fan 2018-05-15 20:57
- FDA Study Population Requirement for BE Studies: Ethics or Science jag009 2018-05-18 16:28