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

posted by Helmut Homepage – Vienna, Austria, 2018-05-15 22:16 (2957 d 21:13 ago) – Posting: # 18766
Views: 3,474

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.

Dif-tor heh smusma 🖖🏼 Довге життя Україна! [image]
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes

Complete thread:

UA Flag
Activity
 Admin contact
23,655 posts in 4,993 threads, 1,570 registered users;
166 visitors (0 registered, 166 guests [including 29 identified bots]).
Forum time: 19:29 CEST (Europe/Vienna)

I have finally come to the konklusion
that a good reliable set ov bowels
iz worth more to a man
than enny quantity of brains.    Josh Billings

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5