Bioequivalence and Bioavailability Forum • Standardisation of the population

Standardisation of the population [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2017-07-25 21:35 (2459 d 09:13 ago) – Posting: # 17615
Views: 9,980

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:

[image]

† overweight: ≥ 25.0 BMI <30.0

[image]

† obesity: BMI ≥ 30.0

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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Complete thread:

Latest FDA product-specific guidelines – Some questions… nobody 2017-07-19 10:56 [Regulatives / Guidelines]
- Latest FDA product-specific guidelines – Some questions… jag009 2017-07-20 05:12
- Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-24 23:23
  - Latest FDA product-specific guidelines – Some questions… nobody 2017-07-25 09:30
    - Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-25 17:33
      - Standardisation of the population Ohlbe 2017-07-25 18:41
        
        Standardisation of the populationHelmut 2017-07-25 19:35
    - Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-25 18:21
      - Latest FDA product-specific guidelines – Some questions… nobody 2017-07-26 16:27