Bioequivalence and Bioavailability Forum • New trial = new opinion

New trial = new opinion [Regulatives / Guidelines]

posted by Ohlbe – France, 2012-01-11 11:40 (5266 d 11:07 ago) – Posting: # 7898
Views: 3,450

Dear Prashant,

If it is a new trial, it is not a change to an ongoing trial, and there is no provision in ICH GCP for expedited approval in such situations...

Regards
Ohlbe

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Regards
Ohlbe

Complete thread:

Expedited Review from IEC in case of change in study design amatewadi 2012-01-09 12:46 [Regulatives / Guidelines]
- Expedited Review from IEC in case of change in study design Ohlbe 2012-01-09 15:54
  - Expedited Review from IEC in case of change in study design amatewadi 2012-01-11 05:31
    - New trial = new opinionOhlbe 2012-01-11 10:40
- Sample size: parallel ≠ 2× cross-over! Helmut 2012-01-09 16:22
- Expedited Review from IEC in case of change in study design drgunasakaran1 2012-01-13 17:51
  - Expedited Review from IEC in case of change in study design amatewadi 2012-01-22 14:26