msmnainar
★    

India,
2013-05-09 11:05
(4790 d 13:26 ago)

Posting: # 10558
Views: 3,430
 

 Scaled ABE for patient BE studies [Design Issues]

Dear All

Is it possible to adopt SABE design for BE study using patient populations?

Request your insight on this.

Regards

Sundar. M
d_labes
★★★

Berlin, Germany,
2013-05-10 10:19
(4789 d 14:11 ago)

@ msmnainar
Posting: # 10565
Views: 2,730
 

 Why not?

Dear Sundar,

❝ Is it possible to adopt SABE design for BE study using patient populations?


AFAIK there is nowhere written in the literature or in the guidances that the scaled ABE approach is limited to studies with volunteers (healthy subjects).
Further I can't imagine any reasons that it should be.

Regards,

Detlew
msmnainar
★    

India,
2013-05-29 11:17
(4770 d 13:14 ago)

@ d_labes
Posting: # 10683
Views: 2,553
 

 Why not?

Dear Detlefff

Sorry for the dealy in response. My concern is, most of the patient PK studies will be on group basis. Is there any statistical procedure to combine data obtained on group basis using RSABE design or same set of procedure will applicable when combining the group?

Need your advise.


Thanks and Regards

Sundar. M
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