Individual/Population Bioequivalence [General Sta­tis­tics]

posted by Harish Kaushik – India, 2015-02-02 13:16 (3811 d 00:13 ago) – Posting: # 14350
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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

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