Population Bioequivalence (PBE) analysis for in-vitro studies [Regulatives / Guidelines]

posted by balakotu – India, 2019-05-22 07:41 (761 d 13:22 ago) – Posting: # 20288
Views: 2,312

(edited by balakotu on 2019-05-23 07:07)

Dear All,

any one help to below topic..............

Population Bioequivalence (PBE) analysis is required for in-vitro studies as per FDA guidance for few products like Iron Sucrose Injection, Ciclosporine Ophthalmic Emulsion, Azelastine Nasal spray etc.

For performing PBE analysis there are two statistical methods
1. One-sided PBE
2. Traditional PBE

Which method is most preferable out of the two methods?

If the study is meeting criteria as per one-sided PBE analysis & not meeting the criteria as per the traditional PBE analysis, whether that study will be accepted by regulatory?

Which is the better method for PBE analysis that regulatory will accept?

Thanks& Regards
Kotu.

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