Re: RE: What are the best studies to combine?

From: musor000@optonline.net Subject: Re: RE: [NMusers] What are the best studies to combine? Date: Thu, 30 Mar 2006 18:24:59 -0500 Hello Malaz and Mark, Thank you for your responses. The primary objective is to look how demographic covariates affect PK parameters. The problem/question is: Will such diverse studies provide reliable information on covariates (gender, weight, and age)? If SC study of diseased subjects provide reliable estimates of Ka (sparse data from the phase 3 study, measures are taken before dosing), then I can estimate it for each subject. Otherwhise, I have to assume that Ka is the same for all subjects within this study. Ka is not the most important parameter. Probably, it is reasonable to do screening to find potential predictors. Then it is reasonable to add potential covariates and study number to the population PK model. I use different errors for each study. Otherwhise, the model does not converge well. Thank you, Pavel