Phase III trail popPK sample size

From: "TANG,MEI" meitang@ufl.edu Subject: [NMusers] Phase III trail popPK sample size Date: Thu, 16 Nov 2006 20:38:04 -0500 (EST) Dear NMusers, The number of patients involved in our phase III trial is huge. The proposed sampling scheme is sparse. however,it is impossible to collect samples from all patients ($$?). We want to randomly select a subpopulation to collect PK samples. I was wondering what is the "typical" number of PK samples and subjects reported in phase III PopPK study? We have already developed the Pop PK/PD model based on the Phase I and II study. According to FDA popPK guidance, the sample scheme can be multiple trough points or optimal sample points. I was wondering which one is better. Your suggestion will be highly appreciated! Regards, Mei