eswar
●    

2008-01-28 12:30
(6727 d 03:57 ago)

Posting: # 1564
Views: 4,735
 

 steady state BA/BE study analysis [Design Issues]

hi

this is eswar, working as a statistician in a CRO. I would like to go for analysis of one steady state study. please provide to me about study state study, what are the parameters used in analysis of steady state studies, and how they calculate.

please provide to me one example on steady state studies.

thanks & regards

eswar
Jaime_R
★★  

Barcelona,
2008-01-28 13:41
(6727 d 02:46 ago)

@ eswar
Posting: # 1566
Views: 4,094
 

 steady state BA/BE study analysis

Dear Eswar!

❝ I would like to go for analysis of one steady state study. please provide to

❝ me about study state study,...


Search the forum. :cool:
For basics see this post, for references that one.

❝ ... what are the parameters used in analysis of steady state studies


Main parameters are AUC0-tau (or if diurnal variation is possible AUC0-24h), Css,max, PTF ([Css,max-Css,min]/Css,av, where Css,av=AUC0-tau/tau),...
See also the guideline page.

❝ ... and how they calculate.


By noncompartmental analysis (NCA).

❝ please provide to me one example on steady state studies.


Please do your homework first; sorry, but this would go beyond the limits of a single post. We are posting here in our leisure time - maybe one of Helmut's lectures would help (look for the 'Istanbul' series).

Regards, Jaime
opinion@experience
●    

2008-07-16 14:20
(6557 d 03:07 ago)

@ Jaime_R
Posting: # 2046
Views: 3,821
 

 steady state BA/BE study analysis

You may also need to include Cssmin and Percent Swing.
Nirali
★    

India,
2008-02-15 08:29
(6709 d 07:58 ago)

@ eswar
Posting: # 1613
Views: 3,899
 

 steady state BA/BE study analysis

Dear Eswar,

Canadian guideline [Conduct & Analysis of BA and BE studies-Part B: Oral Modified Release Formulations] has best examples for steady state analysis.

May I know which software are you using for Bioequivalence analysis?

Thanks & Regards,
Nirali
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