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RegisterNTI drugs with moderate to high variability [Regulatives / Guidelines]
Hi arl_stat.
That's only true if you aim for Europe (EMA) or regulatory bodies which use similar recommendations.
For the FDA the story is different. They recommend RSABE for NTIDs. Search the forums category [RSABE / ABEL] or search the whole forum for "FDA NTID".
Not always. See f.i. this post with at least moderate variabilities for Cmax of NTIDs.
The EMA doesn't make a distinction based on variability in their NTID criteria.
For the FDA the story is again different.
See the warfarin guidance for NTIDs with low variability.
See the dabigatran guidance for NTIDs with moderate to high variabilities. See also this thread wich discussed that topic.
❝ The BE criteria for NTI drugs is 90-111%.
That's only true if you aim for Europe (EMA) or regulatory bodies which use similar recommendations.
For the FDA the story is different. They recommend RSABE for NTIDs. Search the forums category [RSABE / ABEL] or search the whole forum for "FDA NTID".
❝ It is expected to have a low variability for NTI drugs.
Not always. See f.i. this post with at least moderate variabilities for Cmax of NTIDs.
❝ What is the BE criteria for known NTI drugs who possess moderate to high variability?
The EMA doesn't make a distinction based on variability in their NTID criteria.
For the FDA the story is again different.
See the warfarin guidance for NTIDs with low variability.
See the dabigatran guidance for NTIDs with moderate to high variabilities. See also this thread wich discussed that topic.
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Regards,
Detlew
Regards,
Detlew
Complete thread:
- NTI drugs with moderate to high variability arl_stat 2015-12-10 06:53
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- NTI drugs with moderate to high variabilityd_labes 2015-12-10 08:47
- NTI drugs with moderate to high variability arl_stat 2015-12-14 06:00
- NTI drugs with moderate to high variabilityd_labes 2015-12-10 08:47
Ing. Helmut Schütz