balakotu
★    

India,
2019-05-22 07:41
(edited by balakotu on 2019-05-23 07:07)

Posting: # 20288
Views: 395
 

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

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.
ElMaestro
★★★

Denmark,
2019-05-23 08:50

@ balakotu
Posting: # 20296
Views: 308
 

 Population Bioequivalence (PBE) analysis for in-vitro studies

Hello kotu,

» 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

I am not sure what is meant here, can you elaborate?
How did you see two options for PBE apart from vague hints that applicants may propose their own methods etc?

PBE is well-defined but largely abandoned for in vivo crossover studies. For in vitro trials, your situation, a variant of PBE was introduced in the Budenoside guidance and it is often your method of choice.

» 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?

Rhetorically, you are testing the question using the method you specified in your protocol prior to conducting the experiment.

I could be wrong, but...
Best regards,
ElMaestro
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