Bioequivalence and Bioavailability Forum

Population/Individual Bioequivalence [General Statistics]

posted by Helmut – Vienna, Austria, 2015-02-02 14:30 (4164 d 02:13 ago) – Posting: # 14352
Views: 10,425

Hi Kaushik,

❝ 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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Complete thread:

Individual/Population Bioequivalence Harish Kaushik 2015-02-02 12:16
- 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

Population/Individual Bioequivalence [General Sta­tis­tics]

Complete thread:

Population/Individual Bioequivalence [General Statistics]