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Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by Ramesh Ramalingam - India, 2018-04-09 05:54  - Posting: # 18654
Views: 1,201

Dear All,

Till now, USFDA has not issued product specific bioequivalence recommendation to conduct the Primidone BE study. Any one could suggest, what to estimate in the Primidone BE study for USFDA submission, Whether required to estimate parent (Primidone) and metabolite Phenobarbital and phenylethylmalonamide (PEMA) or parent only?


Regards,
Ramesh.R


Edit: Relax; see also this post #9. I deleted your other post which is less than two days old… [Helmut]

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