FDA Study Population Requirement for BE Studies: Ethics or Science [Regulatives / Guidelines]

posted by bebac_fan – US, 2018-05-15 20:57  – Posting: # 18767
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Hi Obinoscopy,

Thanks for bringing this up for discussion. We can all think of many examples where PK in intended populations may be different than the general. However, it is hard to think of situations where a physiological state will selectively alter the PK of a test drug.

After thinking for a bit, and quite a bit of stretching, I could come up with gastric pH (e.g. increased in elderly) maybe affecting BA for a pH liable dispersion matrix. Perhaps other formulation dependent things for reduced GI motility. But I think this is in general a "feel good" clause and not scientifically rooted.

Cheers
BF

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