Sasi
☆    

2008-09-30 12:48
(6476 d 19:32 ago)

Posting: # 2444
Views: 2,869
 

 Distribution of meal in BA/BE studies [Design Issues]

Dear All

In what basis meal distribution will be desided in BA/BE studies for example 4, 9, 13 hours post dose (lunch, snacks and dinner) respectivley
QA-Clinical
☆    

2008-10-03 16:25
(6473 d 15:55 ago)

@ Sasi
Posting: # 2472
Views: 2,178
 

 Distribution of meal in BA/BE studies

Dear Sasi,

The FDA Guidance for Industry for Bioavailability and Bioequivalence studies -Food Effect can provide some information.

Hope it helps.

Regards
QA-Clinical

❝ In what basis meal distribution will be desided in BA/BE studies for example 4, 9, 13 hours post dose (lunch, snacks and dinner) respectivley

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