Bioequivalence and Bioavailability Forum

Individual/Population Bioequivalence [General Statistics]

posted by Harish Kaushik – India, 2015-02-02 13:16 (4165 d 03:01 ago) – Posting: # 14350
Views: 12,092

Hello HS & Forum members

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?

If I understand rightly, FDA/EMEA considers only Average bioequivalence for establishing the BE of formulations?

Correct me if iam wrong, may be this is reason why in bear software we don't have option to calculate IBE/PBE

Finally, I would like to hear from experts out there, about the status of IBE/PBE statistical analysis, Does it have any relevance now?

Regards
Kaushik

Complete thread:

Individual/Population BioequivalenceHarish Kaushik 2015-02-02 12:16
- Population/Individual Bioequivalence Helmut 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

Individual/Population Bioequivalence [General Sta­tis­tics]

Complete thread:

Individual/Population Bioequivalence [General Statistics]