RE: Reporting of interim models in Pop PK Reports

From: "Diane R Mould" drmould@attglobal.net Subject: RE: [NMusers] Reporting of interim models in Pop PK Reports Date: Tue, 18 Jul 2006 15:22:03 -0400 Mark I tend to agree that there are many times when "logic" in modeling defies description J That said, I think that trying to explain what led you to a particular model isnt a bad idea. The need to explain this is often dependent on the study / Phase that the data come from. If a model has been developed previously for a NCE, then there should be little need for long descriptions of why models were selected for evaluation. The model should be able to be fairly well specified in the analysis plan. Similarly if an agent is of a particular class of drugs that generally exhibits certain behaviors, then the rationale for model development should be fairly clear, at least in theory Diane