Bioequivalence and Bioavailability Forum • Expedited Review from IEC in case of change in study design

Expedited Review from IEC in case of change in study design [Regulatives / Guidelines]

posted by amatewadi – Pune, 2012-01-09 13:46 (5283 d 22:33 ago) – Posting: # 7880
Views: 4,167

Dear all,

Can IEC give expedited approval for protocol in case "change in study design (crossover to parallel) on basis of previously approved and conducted study with increasing the sample size two times" ?

Regards
Prashant.

Complete thread:

Expedited Review from IEC in case of change in study designamatewadi 2012-01-09 12:46
- 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 opinion Ohlbe 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