Dhruv Shah
☆    

India,
2016-03-11 03:48

Posting: # 16088
Views: 4,357
 

 t1/2 prior to Tmax in BE study [NCA / SHAM]

In a recent BE study I observed that t1/2 (1 hrs) was faster than Tmax (1.3 hrs). I wanted to know that what does it mean? Moreover if we analyze the data of individual subjects, the occurrence was more in test as compared to reference product. Do we need any special design precautions in such study?


Edit: Category changed. Please follow the Forum’s Policy[Helmut]
jag009
★★★

NJ,
2016-03-11 20:25

@ Dhruv Shah
Posting: # 16098
Views: 3,553
 

 t1/2 prior to Tmax in BE study

Hi,

Did you sample PK adequately?

John
Dhruv Shah
☆    

India,
2016-03-16 07:01
(edited by Ohlbe on 2016-03-16 09:53)

@ jag009
Posting: # 16107
Views: 3,220
 

 t1/2 prior to Tmax in BE study

» Did you sample PK adequately?

yes John we have taken that precaution to have adequate points near Tmax


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
mittyri
★★  

Russia,
2016-03-11 22:20

@ Dhruv Shah
Posting: # 16099
Views: 3,511
 

 t1/2 prior to Tmax in BE study

Hi Dhruv Shah,

Please search the forum and you'll find some gems.

Kind regards,
Mittyri
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