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RegisterPrimidone BE study for USFDA submission [Regulatives / Guidelines]
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]
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]
Complete thread:
- Primidone BE study for USFDA submissionRamesh Ramalingam 2018-04-09 05:54 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Primidone BE study for USFDA submission jag009 2018-04-09 16:16
- Primidone BE study for USFDA submission bebac_fan 2018-04-10 01:11
- Primidone BE study for USFDA submission Ramesh Ramalingam 2018-04-11 06:07
- Primidone BE study for USFDA submission Ramesh Ramalingam 2018-04-11 06:05
- Primidone BE study for USFDA submission bebac_fan 2018-04-10 01:11
- Primidone BE study for USFDA submission balakotu 2018-04-12 15:01
- Primidone BE study for USFDA submission jag009 2018-04-09 16:16
Ing. Helmut Schütz