Bioequivalence and Bioavailability Forum • "ISR"

"ISR" - apologies [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2013-04-24 09:44 (4814 d 14:31 ago) – Posting: # 10482
Views: 17,174

❝ I hope this answers your question.

Yes, that answers a lot of my concerns. What I was wondering, more precisely, is the same old question I have on ISR, and that is whether anyone has been referred to CMDh for not providing ISR in a ruMRP. I'd like to hear the committee's reasoning for denying an ruMRP based on lack of ISR, when an ruMRP is based solely on a previously accepted dossier and now back up by several years of the actual product being taken by patients, yada, yada, yada. We are being told to refer back to the Q&A document for our answer, which says nothing or tells me that they expect some kind of justification for lack of ISR or else the ruMRP will be denied, which as I've mentioned before makes no sense. It's so difficult to get go advice, because each country is unsure what another country's position on a given issue will be (see the NL in Helmut's case; everything seemed fine with the other CMSs and DE). Very frustrating.

Complete thread:

Incurred sample reanalysis sarada06884 2013-04-09 12:22 [Regulatives / Guidelines]
- Incurred sample reanalysis Ohlbe 2013-04-09 14:09
  - Incurred sample reanalysis The Outlaw Torn 2013-04-10 08:40
    - Clopidogrel Ohlbe 2013-04-10 10:34
      - Clopidogrel The Outlaw Torn 2013-04-10 11:31
        
        Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 17:01
        
        Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-22 18:56
        
        Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 19:35
        
        "Meth" - apologies ElMaestro 2013-04-22 20:03
        
        "Meth" - apologies The Outlaw Torn 2013-04-23 08:27
        
        "Meth" - apologies ElMaestro 2013-04-23 14:29
        
        "ISR" - apologiesThe Outlaw Torn 2013-04-24 07:44
        
        Repeat use ElMaestro 2013-04-24 11:08
        
        Repeat use Ohlbe 2013-04-24 11:41
        
        Repeat use ElMaestro 2013-04-24 13:45
        
        "ISR" – resolved Helmut 2013-09-20 21:50
        
        "ISR" – resolved Dr_Dan 2013-09-22 16:56
        
        Lack of ISR / only 5% ISR in study with 656 samples ElMaestro 2013-04-23 23:31
        
        Some more stuff Helmut 2013-04-24 02:08
        Lack of ISR / only 5% ISR in study with 656 samples nobody 2014-10-23 10:06