Bioequivalence and Bioavailability Forum • Incurred sample reanalysis

Incurred sample reanalysis [Regulatives / Guidelines]

posted by The Outlaw Torn – Europe, 2013-04-10 10:40 (4823 d 20:55 ago) – Posting: # 10387
Views: 17,356

Dear Ohlbe,

❝ The long-term stability is not the only issue anyway: back-conversion during sample processing can be of greater concern. And are you sure you know all metabolites ? EMA got trapped in their recommendations on clopidogrel¹

I just happened to be cruising by this joint looking for anything new on ISR. Glad to see you tapping this subject. You answered a lot of my questions, except I'm not sure I understand what you mean by the EMA getting trapped. Do you mean that there are ways around justifying clopidogrel, or other drugs known for back-conversion, that EMA hadn't considered (the paper you quoted where the authors found a way of controlling back-conversion)? Is that it? If that's not the case, mind expanding on this while I sit back and have a drink?

Thanks,
Outlaw

Complete thread:

Incurred sample reanalysis sarada06884 2013-04-09 12:22
- Incurred sample reanalysis Ohlbe 2013-04-09 14:09
  - Incurred sample reanalysisThe 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" - 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