Standardisation of the population [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-07-25 21:35 (2438 d 02:16 ago) – Posting: # 17615
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Dear Ohlbe,

❝ The FDA wants to have a population that is as representative and varied as possible (males and females, different race/ethnicities...). EMA recommends to standardise the population much more. After arguing a lot, industry and CROs managed to relax the limits for BMI compared to the previous version of the guideline (used to be 18 to 25, now 18.5 to 30).


I never understood the FDA’s obsession with “the general population” when it comes to the BMI. Honestly, I never had data of an ANDA-study on my desk where subjects were even close to what the US CDC reports:

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† overweight: ≥ 25.0 BMI <30.0

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† obesity: BMI ≥ 30.0


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