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 Helmut – Vienna, Austria, 2013-04-22 21:35 (4423 d 10:33 ago) – Posting: # 10462
Views: 15,029

Ahoy, my Capt’n, ahoy!

❝ 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?!?

That’s not a fear, but PSRPH… ISR ‘worked’ nicely in 5% of samples (in June), but 10% are “required” (published in August). Ha!

❝ […] and go ahead full throttle.

Do I look like James Dean?

❝ If any situation would merit a deviation from the guideline's requirement then this development would be a good candidate, wouldn't it.

I’m in the right mood for it. :-D

❝ Anyways to mitigate any risk, if this was a compound like meth (very -very!- low CV intra) …

Good guess. Not exactly meth (that was the story at the end of this post), but close. Remember the recent Two-Stage thread?

❝ … 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.

Please no. BTW, at a meeting at the BfArM in 2010 they were surprised that we have done the MD study at all: “We expect that such a study will not be necessary any more according to the new MR GL.” Accumulation in the MD study was <1%…

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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 samplesHelmut 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