Sundar.M
☆    

India,
2019-02-15 12:37

Posting: # 19925
Views: 523
 

 Dose curve [PK / PD]

Dear all,

How to choose dose for any PK/PD study (without non-clinical data) in healthy volunteer for Phase-1 trials for already marketed product? Other words, how to choose the proposed dose to detect clinically meaningful differences in PK/PD responses?

Thanks for your help.

Thanks
MSMN
Activity
 Admin contact
20,246 posts in 4,261 threads, 1,397 registered users;
online 6 (0 registered, 6 guests [including 5 identified bots]).
Forum time (Europe/Vienna): 23:45 UTC

To call the statistician after the experiment is done
may be no more than asking him to perform a postmortem examination:
he may be able to say what the experiment died of.    R.A. Fisher

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