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RegisterLatest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]
Hy everybody!
Had a quick glance at the latest FDA guidances/revisions and found some stuff I don't understand immediately:
- Aspirin+Omeprazole delayed release tablet: BE for ASS based on both, ASS and SS
- Aspirin ER capsule or Aspirin capsule (from 2015): BE based on ASS alone
Any obvious reason for this?
- Tiopronin tablet (Shkreli compound): Only 1 study in fasted state
Are there more compounds not requiring fed state study?
- Metoprolol tartrate: BCS-biowaiver requires data other than "peer-reviewed articles"
Plausible to me, own experimental data on solubility might be required. Has anybody identified a PAR with successful BCS-biowiaver?
- Propafenon: Highly variable.
Is CYP2D6 substrate, poor/ultrarapid metabolizers might be the reason for high variability? Why not pheno/genotype the volunteers for BE-trial, to minimize variability?
...just asking
Had a quick glance at the latest FDA guidances/revisions and found some stuff I don't understand immediately:
- Aspirin+Omeprazole delayed release tablet: BE for ASS based on both, ASS and SS
- Aspirin ER capsule or Aspirin capsule (from 2015): BE based on ASS alone
Any obvious reason for this?
- Tiopronin tablet (Shkreli compound): Only 1 study in fasted state
Are there more compounds not requiring fed state study?
- Metoprolol tartrate: BCS-biowaiver requires data other than "peer-reviewed articles"
Plausible to me, own experimental data on solubility might be required. Has anybody identified a PAR with successful BCS-biowiaver?
- Propafenon: Highly variable.
Is CYP2D6 substrate, poor/ultrarapid metabolizers might be the reason for high variability? Why not pheno/genotype the volunteers for BE-trial, to minimize variability?
...just asking
—
Kindest regards, nobody
Kindest regards, nobody
Complete thread:
- Latest FDA product-specific guidelines – Some questions…nobody 2017-07-19 10:56
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- 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