Drug prophylaxis: PK interaction? [Study Performance]
Dear Both,
Thanks for the reply.
My other concern was safety (after ruling out p/k interaction). I want to know how one will be able to differentiate that a particular adverse event is because of study mediction or due to prophylactic drug.
Finally, Is such study data acceptable by regulatory authorities because i came across no examples of such studies during my search on internet.
Thanks & Regards,
Deepak
--
Edit: Full quote removed. Please see this post! [Jaime]
Thanks for the reply.
My other concern was safety (after ruling out p/k interaction). I want to know how one will be able to differentiate that a particular adverse event is because of study mediction or due to prophylactic drug.
Finally, Is such study data acceptable by regulatory authorities because i came across no examples of such studies during my search on internet.
Thanks & Regards,
Deepak
--
Edit: Full quote removed. Please see this post! [Jaime]
Complete thread:
- Drug prophylaxis: BE trials in healthy volunteers drchilkoti 2008-11-02 09:19
- Drug prophylaxis: PK interaction? Helmut 2008-11-02 18:26
- Drug prophylaxis: PK interaction?drchilkoti 2008-11-03 13:21
- Drug prophylaxis: BE trials in healthy volunteers ElMaestro 2008-11-03 09:16
- Drug prophylaxis: PK interaction? Helmut 2008-11-02 18:26
