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RegisterFDA scaling for NTIDs [Design Issues]
posted by Helmut 
– Vienna, Austria, 2013-01-20 13:46 (4536 d 05:28 ago) – Posting: # 9893
Views: 8,029
Hi Krishna,
We are talking about the FDA. Until recently FDA did not distinguish between NTIDs and other drugs at all. The acceptance range was 80.00–125.00%, no PE restriction. So the study would have passed anyway. If you read the transcripts of the 2010 and 2011 ACPSCP-meetings you will realize the rationale behind the new method is last but not least political (as is the PE restriction for HVDPs). With the aggregate method ≤21.42 %CV the RSABE will mainly be responsible for the decision and >21.42 conventional ABE. This makes sense, since if a NTID is safe and efficacious despite such a variability there is no reason to impose a restriction. Furthermore as Donald Schuirmann showed in his simulations the patient’s risk has a minimum of ~0.025 at 21.42 %CV.
❝ ❝ The study passes all criteria. What is the problem?
❝
❝ My problem is, here %(T/R): 86.25, it is far way from the 100 and R-R %CV: 26. Due to higher CV it is passing SABE (it would have been failed in SABE if it had low variability). Then how test can be assured with therapeutic equivalence as Reference with out point estimate constraint ?
We are talking about the FDA. Until recently FDA did not distinguish between NTIDs and other drugs at all. The acceptance range was 80.00–125.00%, no PE restriction. So the study would have passed anyway. If you read the transcripts of the 2010 and 2011 ACPSCP-meetings you will realize the rationale behind the new method is last but not least political (as is the PE restriction for HVDPs). With the aggregate method ≤21.42 %CV the RSABE will mainly be responsible for the decision and >21.42 conventional ABE. This makes sense, since if a NTID is safe and efficacious despite such a variability there is no reason to impose a restriction. Furthermore as Donald Schuirmann showed in his simulations the patient’s risk has a minimum of ~0.025 at 21.42 %CV.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- NTIDs with high variability ioanam 2010-06-07 13:52 [Design Issues]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- NTIDs # HVDs (or not?) Helmut 2010-06-07 14:18
- NTIDs # HVDs (or not?) ioanam 2010-06-07 18:17
- Complicated ElMaestro 2010-06-07 18:28
- NTIDs # HVDs (or not?) Dr_Dan 2010-06-08 12:24
- Switch over Helmut 2010-06-08 12:34
- NTIDs # HVDs (or not?) Relaxation 2010-06-09 22:38
- FDA scaling for NTIDs krishna 2013-01-07 14:01
- FDA scaling for NTIDs Helmut 2013-01-12 20:06
- FDA scaling for NTIDs krishna 2013-01-18 10:04
- FDA scaling for NTIDsHelmut 2013-01-20 12:46
- FDA scaling for NTIDs krishna 2013-02-01 12:20
- FDA scaling for NTIDsHelmut 2013-01-20 12:46
- FDA scaling for NTIDs krishna 2013-01-18 10:04
- FDA scaling for NTIDs Helmut 2013-01-12 20:06
- FDA scaling for NTIDs krishna 2013-01-07 14:01
- NTIDs # HVDs (or not?) Relaxation 2010-06-09 22:38
- Switch over Helmut 2010-06-08 12:34
- NTIDs # HVDs (or not?) ioanam 2010-06-07 18:17
- NTIDs # HVDs (or not?) Helmut 2010-06-07 14:18
Ing. Helmut Schütz