balakotu
★    

India,
2023-07-12 06:24
(1058 d 16:21 ago)

Posting: # 23670
Views: 5,114
 

 FDA: PD BE study [Power / Sample Size]

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Dear All,

Please anyone suggest me on how to calculate a Sample size for PD BE study of multiple dose, 3-way crossover (Orlistat capsule 60 mg for USA).

Regards
Kotu.

Edit: Category and subject changed; see also this post #1 and #2. [Helmut]
 
dshah
★★  

India,
2023-07-13 10:45
(1057 d 12:00 ago)

@ balakotu
Posting: # 23671
Views: 4,053
 

 FDA: PD BE study

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Dear Kotu!

❝ Please anyone suggest me on how to calculate a Sample size for PD BE study of multiple dose, 3-way crossover (Orlistat capsule 60 mg for USA).


The recommendation is as given below:
[image]

Based on this, i assume it should be similar to BE study calculation.

Regards,
Divyen
 
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