Standardisation of the population [Regulatives / Guidelines]
Dear Achievwin,
We are already there in Europe - and surviving.
EMA and FDA have a different philosophy there. 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). But then:
- Subjects could belong to either sex; however, the risk to women of childbearing potential should be considered (i.e. studies with only males are perfectly acceptable on this side of the Atlantic and are actually quite frequent)
- Subjects should preferably be non-smokers
- Phenotyping and/or genotyping of subjects may be considered for safety or pharmacokinetic reasons
On another note: please pay attention when replying to messages. If you leave the ❝ sign before what you type, we can't distinguish between what you quote and what you write. Please use the Preview button before submitting your message. Helmut and I had to edit a number of your posts. Please also follow the Forum’s Policy.
❝ 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?
We are already there in Europe - and surviving.
EMA and FDA have a different philosophy there. 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). But then:
- Subjects could belong to either sex; however, the risk to women of childbearing potential should be considered (i.e. studies with only males are perfectly acceptable on this side of the Atlantic and are actually quite frequent)
- Subjects should preferably be non-smokers
- Phenotyping and/or genotyping of subjects may be considered for safety or pharmacokinetic reasons
On another note: please pay attention when replying to messages. If you leave the ❝ sign before what you type, we can't distinguish between what you quote and what you write. Please use the Preview button before submitting your message. Helmut and I had to edit a number of your posts. Please also follow the Forum’s Policy.
—
Regards
Ohlbe
Regards
Ohlbe
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 populationOhlbe 2017-07-25 18:41
- Standardisation of the population Helmut 2017-07-25 19:35
- Standardisation of the populationOhlbe 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