Bioequivalence and Bioavailability Forum • "Meth"

"Meth" - apologies [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2013-04-23 10:27 (4812 d 01:13 ago) – Posting: # 10468
Views: 16,922

Thanks for the example, Helmut. Nothing like a concensus! This is the kind of thing that makes you want to bang your head on your desk! NL have been rather difficult lately for us as well (and Spain). And some of the eastern block countries to, for some reason. Ummmm.

El Maestro, you said "I'd love to see the faces of the CMD(h) members if or when they realise that they have yet another ISR case to deal with." Has anyone challenged ISR to the CMDh yet, as far as you know (I mean, has the committee had to make any decisions regarding ISR or the lack of it)?

Complete thread:

Incurred sample reanalysis sarada06884 2013-04-09 12:22
- 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" - apologiesThe Outlaw Torn 2013-04-23 08:27
        
        "Meth" - apologies ElMaestro 2013-04-23 14:29
        
        "ISR" - apologies The 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