anilpatra
☆    

India,
2015-02-07 08:36
(4159 d 01:11 ago)

Posting: # 14385
Views: 5,490
 

 Population Bioequivalence on In-Vitro data [General Sta­tis­tics]

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Dear Forum members

Can any one please help me on how to perform Population Bioequivalence on In-Vitro data for US-FDA submission. Is there any specific guideline available for these type of studies.

Regards
Anil
 
ElMaestro
★★★

Denmark,
2015-02-07 11:16
(4158 d 22:31 ago)

@ anilpatra
Posting: # 14386
Views: 4,331
 

 Population Bioequivalence on In-Vitro data

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Hi Anil,

❝ Can any one please help me on how to perform Population Bioequivalence on In-Vitro data for US-FDA submission. Is there any specific guideline available for these type of studies.


Perhaps you're looking for the Budesonide draft guidance?
—
Pass or fail!
ElMaestro
 
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