Latest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]

posted by nobody – 2017-07-19 12:56 (2444 d 06:42 ago) – Posting: # 17560
Views: 10,907

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? :-D

- 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

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