Bioequivalence and Bioavailability Forum • 90% CI riddle

90% CI riddle [Bioanalytics]

posted by The Outlaw Torn – Europe, 2012-12-20 12:23 (4542 d 20:42 ago) – Posting: # 9736
Views: 8,312

❝ By this every application for a generic with an "old" BE study can be rejected by retrospective application of the guideline regardless of the scientific justification for missing ISR.

Dear Dan, I am in agreement with you, though I tried to tone down my feelings above. :cool:

It only takes one stubborn assessor to stick to the ISR requirement and you're screwed.

Concerning your comment above, how about repeat use procedures? Is it possible for the authorities to reject such applications because the studies that were initially accepted will now be rejected because they no longer abide by the new guideline? and that's despite the fact that the drug has been on the market for years (and therefore has been shown to be safe and effective)? This Q&A document provides no re-assurances regarding, I would assume, this common concern.

It does raise more questions than it lays to rest, I think.

Outlaw

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 riddleThe Outlaw Torn 2012-12-20 11:23
        
        90% CI riddle Dr_Dan 2012-12-20 12:58