From:"Janet R Wade"
Subject:[NMusers] Regulatory Guidelines Date:Thu, 5 Jun 2003 07:44:29 +0200 Hi Everyone As a service to the modelling community, Exprimo Consulting LLP has put a summary of the FDA, ICH and CPMP regulatory guidances that refer to the population approach, PK/PD modelling, and modelling and simulation onto our web site. To access this document, go to www.exprimo.com and click on the link on the left hand side of the page that says 'Regulatory Guidelines'. The information shown there is Exprimo Consulting LLP?s best understanding of the current regulatory guidances with respect to the different topics presented. The comments and interpretations given under each guidance/regulatory document are Exprimo?s alone and do not reflect the opinion of the relevant regulatory agency. Exprimo will endeavour to ensure that the information presented here is as complete and as up to date as possible, but does not guarantee this. There is considerable overlap between the guidances presented for three different topics, the population approach, PK/PD, and, modelling and simulation, but the information most specific to each topic is presented in the relevant section. For the convenience of the reader, a hyper-link has been inserted to each document discussed. Exprimo would be delighted to hear any comments or suggestions to improve this service. Kind regards to all Janet ____________________________________________ Janet R Wade, PhD Exprimo Consulting LLP http://www.exprimo.com E-mail firstname.lastname@example.org _______________________________________________________