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Let's talk about sex, not gender (which is a sociolgical combat term, implying that all differences between men an women are made up by education. Biology and sex hormones are all secondary. Sounds strange, but...)
So what you are looking for is examples of differences between formulations (not active compounds) in absorption between women and men. Will be hard to find, I guess. Maybe the reason why FDA started with women in BE trials, as there is no sound scientific basis to exclude them.
But we started with genetic polymorphisms. If nothing is published on that: GREAT! Then let's start with studying intraindividual variability (repeated dosing) for different CYP geno/phenotypes. Should be worth going for and has not been done (published) so far!
If you don't see differences on intraindividual variability it should not be worth going for selected geno/phenotypes for this CYP in the future, I guess. Otherwise...
PS: Another term for "difference in geno/phenotype" might be "race". There are compounds with distinct differences in BA depending on race. In principle higher BA should correspond to lower variability (both intra- and interindividual, I guess). Might be worth having a look at in the literature
So what you are looking for is examples of differences between formulations (not active compounds) in absorption between women and men. Will be hard to find, I guess. Maybe the reason why FDA started with women in BE trials, as there is no sound scientific basis to exclude them.
But we started with genetic polymorphisms. If nothing is published on that: GREAT! Then let's start with studying intraindividual variability (repeated dosing) for different CYP geno/phenotypes. Should be worth going for and has not been done (published) so far!
If you don't see differences on intraindividual variability it should not be worth going for selected geno/phenotypes for this CYP in the future, I guess. Otherwise...
PS: Another term for "difference in geno/phenotype" might be "race". There are compounds with distinct differences in BA depending on race. In principle higher BA should correspond to lower variability (both intra- and interindividual, I guess). Might be worth having a look at in the literature
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Subject selection ele2008 2014-10-16 05:06
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Genotyping in BE Helmut 2014-10-16 15:04
- Genotyping in BE ele2008 2014-10-16 16:18
- Genotyping in BE nobody 2014-10-16 17:43
- Genotyping in BE Helmut 2014-10-16 18:13
- Genotyping in BE nobody 2014-10-16 18:24
- Any experiences? Helmut 2014-10-17 19:30
- Any experiences? nobody 2014-10-17 20:04
- Any experiences? Helmut 2014-10-18 15:04
- Any experiences? nobody 2014-10-20 08:06
- Any experiences? Helmut 2014-10-20 13:00
- Any experiences? nobody 2014-10-20 14:21
- Any experiences? Helmut 2014-10-20 13:00
- Any experiences? nobody 2014-10-20 08:06
- Any experiences? Helmut 2014-10-18 15:04
- Any experiences? nobody 2014-10-17 20:04
- Any experiences? Helmut 2014-10-17 19:30
- Genotyping in BE nobody 2014-10-16 18:24
- Genotyping in BE Helmut 2014-10-16 18:13
- Genotyping in BE nobody 2014-10-16 17:43
- Genotyping in BE ele2008 2014-10-16 16:18
- Subject selection ele2008 2014-10-23 05:25
- Subject selection ele2008 2014-10-23 16:47
- Subject selection ElMaestro 2014-10-23 17:25
- Subject selectionnobody 2014-10-23 17:53
- Editing posts Helmut 2014-10-23 17:54
- ♀ on a mission? Helmut 2014-10-23 19:50
- Subject selection ElMaestro 2014-10-23 17:25
- Subject selection ele2008 2014-10-23 16:47
- Genotyping in BE Helmut 2014-10-16 15:04
Ing. Helmut Schütz