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
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Janet R Wade, PhD
Exprimo Consulting LLP
http://www.exprimo.com
E-mail janet.wade@exprimo.com
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