Bioequivalence and Bioavailability Forum • 90% CI riddle

90% CI riddle [Bioanalytics]

posted by Dr_Dan – Germany, 2012-12-20 13:58 (4542 d 18:26 ago) – Posting: # 9737
Views: 8,295

Dear Outlaw
we currently have the problem that a BE study was accepted in a DCP procedure a while ago and now in a repeat use procedure (=new application!) the study is rejected. As you said, it only takes one stubborn (French) assessor to stick to the ISR requirement and you're screwed.
I agree with you, the Q&A document raises more questions than it lays to rest.
Kind regards
Dan

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Kind regards and have a nice day
Dr_Dan

Complete thread:

ISR The Outlaw Torn 2012-11-29 15:58
- ISR Dr_Dan 2012-11-29 16:30
  - ISR The Outlaw Torn 2012-11-30 07:53
  - ISR Ohlbe 2012-12-17 22:53
    - ISR The Outlaw Torn 2012-12-18 08:09
    - 90% CI riddle Helmut 2012-12-18 17:12
      - 90% CI riddle The Outlaw Torn 2012-12-19 07:49
        
        90% CI riddle Dr_Dan 2012-12-20 09:45
        
        90% CI riddle The Outlaw Torn 2012-12-20 11:23
        
        90% CI riddleDr_Dan 2012-12-20 12:58