Bioequivalence and Bioavailability Forum

BE assessment regarding first time point Cmax [Study Assessment]

posted by Mann – India, 2018-12-10 01:28 (1958 d 05:16 ago) – Posting: # 19673
Views: 8,486

Dear Ohlbe,

Thank you for your detailed clarification.

Could you please share your views and suggestions from US-FDA and ICH perspective?

Best regards,
Mann

Complete thread:

BE assessment regarding first time point Cmax Mann 2018-12-09 10:14 [Study Assessment]
- BE assessment regarding first time point Cmax Ohlbe 2018-12-09 23:46
  - BE assessment regarding first time point CmaxMann 2018-12-10 00:28
    - BE assessment regarding first time point Cmax Ohlbe 2018-12-11 00:05
    - FDA and outliers mittyri 2018-12-11 16:38
    - BE assessment regarding first time point Cmax Erkin 2018-12-28 08:29
      - BE assessment regarding first time point Cmax ElMaestro 2018-12-28 14:32
        
        BE assessment regarding first time point Cmax Erkin 2018-12-28 20:57
        
        regulatory reasons to consider the study inadequate Astea 2019-03-02 18:02
        
        Good question, next question Helmut 2019-03-03 19:42
        
        first point Cmax: trouble waiting to happen? Astea 2019-03-03 21:42

BE assessment regarding first time point Cmax [Study As­sess­ment]

Complete thread:

BE assessment regarding first time point Cmax [Study Assessment]