balakotu
★    

India,
2014-01-15 08:02
(4548 d 06:41 ago)

Posting: # 12170
Views: 3,440
 

 Population Bioequivalence for In Vitro Data [Regulatives / Guidelines]

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Dear All,
Please clarify,

In Vitro data (Example: D50) how to calculate 95% CI using population bioequivalence

http://www.pqri.org/commworking/minutes/pdfs/dptc/psdpcwg/Addl/DC01-526048-v1-PBE_Description_for_PQRI_Prof_Comp.pdf

From above link in page no.3 how to calculate MSB_T and MSB_R (sample variance). Please provide SAS code for calculating sample variance for Test and Reference individually.
 
ElMaestro
★★★

Denmark,
2014-01-16 00:17
(4547 d 14:26 ago)

@ balakotu
Posting: # 12176
Views: 2,807
 

 Population Bioequivalence for In Vitro Data

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Hi balakotu,

❝ From above link in page no.3 how to calculate MSB_T and MSB_R (sample variance). Please provide SAS code for calculating sample variance for Test and Reference individually.


Perhaps you'd want to look at the Budesonide draft guidance?
—
Pass or fail!
ElMaestro
 
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