4 replies to this topic

[raghava choudary]

Can Population pharmacokinetic analysis be performed on data from a phase I study ??

[serge guzy]

Can Population pharmacokinetic analysis be performed on data from a phase I study ??

of course, from preclinical to Phase 3 included.

best

Serge

[smouksassi1]

While in Phase I you might have only Healthy with limited vriation in covariates values the Phase I data are typically very helpful since they are in rich in sampling which help in determining the structural model etc. and then as Serge pointed out you can cumulatively enhance your model by bringing in Phase II and Phase III patient data to understand sources of variability.

Samer

[raghava choudary]

Hi Serge / Samer / Simon,

 

Thank you for the reply,

 

I have one more question like can we combine multiple dosing data (i.e from MAD study) with Data from Single ascending dose for population PK ?

 

Thanks in advance,

 

RC

[Simon Davis]

Again yes, simply use append to put the data in the same worksheet, some individuals will have many doses and other just one.  However there is no problem to have them in the same analysis althoguh you may want to be careful when identifying covariates etc. incase it is an artefact of the different grousp/regimens