Bioequivalence and Bioavailability Forum • Primidone BE study for USFDA submission

Primidone BE study for USFDA submission [Regulatives / Guidelines]

posted by jag009 – NJ, 2018-04-09 18:16 (2205 d 21:24 ago) – Posting: # 18656
Views: 3,781

Haven't looked up the drug but are both metabolites active? To be on the safe side (if you don't want to file control correspondence) then i would measure the active metabolites since FDA usually ask to have the data collected.

John

Complete thread:

Primidone BE study for USFDA submission Ramesh Ramalingam 2018-04-09 05:54 [Regulatives / Guidelines]
- Primidone BE study for USFDA submissionjag009 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 balakotu 2018-04-12 15:01