Bioequivalence and Bioavailability Forum • Lack of ISR / only 5% ISR in study with 656 samples

Lack of ISR / only 5% ISR in study with 656 samples [Regulatives / Guidelines]

posted by ElMaestro – Denmark, 2013-04-22 20:56 (4815 d 04:42 ago) – Posting: # 10461
Views: 17,210

Hi Hötzi,

sad story. 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. The details are good: the ISR seemed to work well in June, but NL's fear is it didn't in April?!?

I might be inclined to play the regulatory chicken game and go ahead full throttle. If any situation would merit a deviation from the guideline's requirement then this development would be a good candidate, wouldn't it.
Anyways to mitigate any risk, if this was a compound like meth (very -very!- low CV intra) then you'd be looking at 12-16 subjects in a 222-BE trial. Would be a cheapo and could be done and dusted by any CRO way before the end of a clockstop.

—
Pass or fail!
ElMaestro

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 samplesElMaestro 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