Phaneendra.K
☆    

2011-03-10 13:39
(5576 d 14:52 ago)

Posting: # 6738
Views: 5,926
 

 Intra Subject Variability [Power / Sample Size]

Hello,

Intrasubject variability. Is this expected value or calculated. How does this parameter have pertinence in study performance.

Thanks and Regards,

PK
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2011-03-10 13:50
(5576 d 14:41 ago)

@ Phaneendra.K
Posting: # 6741
Views: 4,914
 

 Intra Subject Variability

Hi Phani!

❝ Intrasubject variability. Is this expected value or calculated.


Since you posted in the Sample Size category: It's one of the four fixed values (α, acceptance range, T/R-ratio, CV). Based on those you calculate power (1–β).

❝ How does this parameter have pertinence in study performance.


In the study itself, none. But since the value is based on MSE, the higher the CV for any given sample size, the wider the confidence interval.
Alpesh Ramani
☆    

Ahmedabad, India,
2011-03-14 10:10
(5572 d 18:21 ago)

@ Helmut
Posting: # 6756
Views: 5,024
 

 Intra Subject Variability

Dear HS,

Intrasubject CV is molecule property or its' also affected by formulation property?

For different strengh of same molecule observed with different % CV and repeat study with same strength also observed with different study.

As everybody know that % CV is used to calculate the sample size. So it is always a matter of confusion with % CV take for sample size calculation for next study, i.e., First pilot, recent study or literature based CV.

Kindly provide your valuable inputs with this regards.

Alps
ElMaestro
★★★

Denmark,
2011-03-14 10:19
(5572 d 18:12 ago)

@ Alpesh Ramani
Posting: # 6757
Views: 4,773
 

 Intra Subject Variability

Hello Alpesh Ramani,

❝ Intrasubject CV is molecule property or its' also affected by formulation property?


Both.

❝ As everybody know that % CV is used to calculate the sample size. So it is always a matter of confusion with % CV take for sample size calculation for next study, i.e., First pilot, recent study or literature based CV.


There is no easy answer. I would use the CV-value that appears most trustworthy from your source material. Age of study, apparent standard of conduct, and N would all play a role. I would not pool studies, but that of course is a personal and subjective comment.

Pass or fail!
ElMaestro
UA Flag
Activity
 Admin contact
23,654 posts in 4,992 threads, 1,571 registered users;
139 visitors (0 registered, 139 guests [including 22 identified bots]).
Forum time: 05:31 CEST (Europe/Vienna)

Always listen to experts.
They’ll tell you what can’t be done and why.
Then do it.    Robert A. Heinlein

The Bioequivalence and Bioavailability Forum is hosted by
BEBAC Ing. Helmut Schütz
HTML5