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RegisterPopulation/Individual Bioequivalence [General Statistics]
posted by Helmut 
– Vienna, Austria, 2015-02-02 14:30 (3364 d 11:57 ago) – Posting: # 14352
Views: 8,284
Hi Kaushik,
AFAIK, yes.
No. If the FDA is concerned, parts of the methodology enter the scene through the back door, e.g., comparing within-subject variances of NTIDs (warfarin guidance) and the subject-by-formulation interaction (ER methylphenidate guidance).
❝ I have read in a BEBAC forum posted by HS that the concept of Individual/Population Bioequivalence is no longer considered by FDA/other regulatory agencies, Is it true?
AFAIK, yes.
- FDA abandoned PBE/IBE more than a decade ago. PBE/IBE is not mentioned in CFR21/320. Not a single word in the current drafts for ANDAs (2013) and NDAs/INDs (2014). Only: “We recommend that applicants use the average BE method of analysis with these study designs for establishing BE.”
- In Europe PBE/PBE was never implemented.
❝ Finally, I would like to hear […] about the status of IBE/PBE statistical analysis, Does it have any relevance now?
No. If the FDA is concerned, parts of the methodology enter the scene through the back door, e.g., comparing within-subject variances of NTIDs (warfarin guidance) and the subject-by-formulation interaction (ER methylphenidate guidance).
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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:
- Individual/Population Bioequivalence Harish Kaushik 2015-02-02 12:16 [General Statistics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Population/Individual BioequivalenceHelmut 2015-02-02 13:30
- Population/Individual Bioequivalence Harish Kaushik 2015-02-03 05:52
- Population/Individual Bioequivalence jag009 2015-02-27 00:30
- Switching in theory & practice Helmut 2015-02-27 16:37
- theory & practice.... & practice ElMaestro 2015-02-27 17:07
- theory & practice.... & practice nobody 2015-02-27 19:56
- theory & practice.... & practice ElMaestro 2015-02-27 21:04
- theory & practice.... & practice nobody 2015-02-27 21:34
- theory & practice.... & practice ElMaestro 2015-02-27 21:04
- theory & practice.... & practice nobody 2015-02-27 19:56
- theory & practice.... & practice ElMaestro 2015-02-27 17:07
- Population/Individual Bioequivalence Harish Kaushik 2015-02-03 05:52
- Population/Individual BioequivalenceHelmut 2015-02-02 13:30
Ing. Helmut Schütz