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Register"Meth" - apologies [Regulatives / Guidelines]
Hi Outlaw,
It is difficult to challenge the CMD(h) directly; in a DCP they will be on the receiving end of a PSRtPH if a national agency declares one. The CMD(h) doesn't really 'decide' much here, and the members are often relying on their experts since the core business of CMD(h) is regulatory rather than strictly scientific (but please don't ask me to draw the line between what's regulatory and what's science
).
They can talk and they can invite experts for specific issues in a procedure and they can more generally send over issues to the PK work group as needed.
Many companies have submitted study reports without ISR data and many times this has caused trouble at the CMD(h), and this in a sense one reason why the PK work group's statement re. ISR was born.
In a case like Helmut's I believe the CMD(h) members would with very decent effort try to reach consensus for acceptance due to e.g.
"ISR data obtained for the same analyte from other studies carried out in the same laboratory and with the same analytical method may be used as supportive data to justify the lack of ISR."
I hope this answers your question.
❝ 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)?
It is difficult to challenge the CMD(h) directly; in a DCP they will be on the receiving end of a PSRtPH if a national agency declares one. The CMD(h) doesn't really 'decide' much here, and the members are often relying on their experts since the core business of CMD(h) is regulatory rather than strictly scientific (but please don't ask me to draw the line between what's regulatory and what's science
).They can talk and they can invite experts for specific issues in a procedure and they can more generally send over issues to the PK work group as needed.
Many companies have submitted study reports without ISR data and many times this has caused trouble at the CMD(h), and this in a sense one reason why the PK work group's statement re. ISR was born.
In a case like Helmut's I believe the CMD(h) members would with very decent effort try to reach consensus for acceptance due to e.g.
"ISR data obtained for the same analyte from other studies carried out in the same laboratory and with the same analytical method may be used as supportive data to justify the lack of ISR."
I hope this answers your question.
—
Pass or fail!
ElMaestro
Pass or fail!
ElMaestro
Complete thread:
- Incurred sample reanalysis sarada06884 2013-04-09 12:22 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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" - apologiesElMaestro 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
- Repeat use Ohlbe 2013-04-24 11:41
- "ISR" – resolved Helmut 2013-09-20 21:50
- "ISR" – resolved Dr_Dan 2013-09-22 16:56
- Repeat use ElMaestro 2013-04-24 11:08
- "ISR" - apologies The Outlaw Torn 2013-04-24 07:44
- "Meth" - apologiesElMaestro 2013-04-23 14:29
- "Meth" - apologies The Outlaw Torn 2013-04-23 08:27
- "Meth" - apologies ElMaestro 2013-04-22 20:03
- Lack of ISR / only 5% ISR in study with 656 samples Helmut 2013-04-22 19:35
- 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
- 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 17:01
- Clopidogrel The Outlaw Torn 2013-04-10 11:31
- Clopidogrel Ohlbe 2013-04-10 10:34
- Incurred sample reanalysis The Outlaw Torn 2013-04-10 08:40
- Incurred sample reanalysis Ohlbe 2013-04-09 14:09
Ing. Helmut Schütz