Dhruv Shah

2016-03-11 03:48
(1655 d 13:51 ago)

Posting: # 16088
Views: 4,585

 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]

2016-03-11 20:25
(1654 d 21:14 ago)

@ Dhruv Shah
Posting: # 16098
Views: 3,735

 t1/2 prior to Tmax in BE study


Did you sample PK adequately?

Dhruv Shah

2016-03-16 07:01
(1650 d 10:38 ago)

(edited by Ohlbe on 2016-03-16 09:53)
@ jag009
Posting: # 16107
Views: 3,401

 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]

2016-03-11 22:20
(1654 d 19:19 ago)

@ Dhruv Shah
Posting: # 16099
Views: 3,695

 t1/2 prior to Tmax in BE study

Hi Dhruv Shah,

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

Kind regards,
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