Bioequivalence and Bioavailability Forum • Tmax, drop-outs (EMA)

Tmax, drop-outs (EMA) [Regulatives / Guidelines]

posted by pash413 – India, 2012-03-28 19:04 (5203 d 22:25 ago) – Posting: # 8345
Views: 6,700

Dear HS
Thanks for your quick reply

Our formulation is IR formulation, but the reported Tmax is around 6-10 hours.
Further we want to know the the reason/regulatory expectation behind the analysing the drop out/ withdrawal subjects. Will it be useful to establish any correlation between adverse events with the plasma concentration data and may be used to rule out formulation performance as the reason of adverse events? then what about it's applicability for subject who dropout due to personal reason? Please share your view, as USFDA does not require analysis of such dropout subjects.

Drop out handling in Europe Submission Study pash413 2012-03-28 16:04
- Tmax, drop-outs (EMA) Helmut 2012-03-28 16:27
  - Tmax, drop-outs (EMA)pash413 2012-03-28 17:04
    - Tmax, drop-outs (EMA) Helmut 2012-03-28 17:49