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RegisterLatest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]
❝ ❝ Phenotype is not advisable in generic arena (IMHO) as we want to document that this drug is BE in general populating (meaning any breathing soul)....
❝
❝ EMA allows. See Jun 2017 by Laszlos and H- Blume on "real life" vs. "highly discriminative" in BE study requirements in various regions. Spoiler: Very inconsistent, in general... 
BE guidance tries to avoid bias (cherry picking) therefore excluded Phenotyping and avoiding fast and slow metabolizers.... if we allow phenotyping then next someone will come and ask for BMI exceptions and then smoker exclusion where is the end?
Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5 and follow the Forum’s Policy. [Helmut]
Complete thread:
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-19 10:56
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 population Helmut 2017-07-25 19:35
- Standardisation of the population Ohlbe 2017-07-25 18:41
- 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
- Latest FDA product-specific guidelines – Some questions…Achievwin 2017-07-25 17:33
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-25 09:30
Ing. Helmut Schütz