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Re: Pharmacoeconomic simulations

From: Jeffrey Barrett <barrettj>
Date: Thu, 23 Apr 2009 11:02:41 -0400


The best paper I know is by Hughes et al - see below with abstract

Hughes DA, Walley T. Economic evaluations during early (phase II) drug =
development: a role for clinical trial simulations? Pharmacoeconomics. =


Faced with increasing demands on demonstrating cost effectiveness, =
pharmaceutical companies are required to conduct pharmacoeconomic =
evaluations throughout the drug development programme. At present, there =
is particular emphasis in the literature on burden-of-illness studies and =
on economic evaluations conducted alongside phase III clinical trials but =
not on those conducted during phase II clinical trials. This article =
describes modelling techniques, namely clinical trial simulations (CTS), =
which are gaining popularity in the clinical research community, but which =
might also prove to be beneficial during the conduct of these early =
pharmacoeconomic evaluations. The basic concepts and structure of CTS are =
described by using published examples of simulations of antipsychotic and =
anticancer drugs. With the use of an illustrative example of a hypothetical=
 cholinesterase inhibitor for Alzheimer's disease, an integrated CTS-based =
pharmacoeconomic evaluation is presented. The results demonstrate how the =
modelling may be of value in 'go/no-go' decisions during the drug =
development programme.



Jeffrey S. Barrett, Ph.D.
Research Associate Professor, Pediatrics
Director, Pediatric Pharmacology Research Unit,
Laboratory for Applied PK/PD
Clinical Pharmacology & Therapeutics
Abramson Research Center, Rm 916H
The Children's Hospital of Philadelphia
3615 Civic Center Blvd.
Philadelphia, PA 19104

KMAS (Kinetic Modeling & Simulation)
Institute for Translational Medicine
University of Pennsylvania
email: barrettj
Ph: (267) 426-5479

>>> "Bonate, Peter" <Peter.Bonate
Is anyone aware of any papers or abstracts using computer-assisted trial =
design that incorporates a pharmacoeconomic component to the simulation? =
Or any pop pharmacokinetic-pharmacodynamic papers that include the same?


Pete bonate

Peter L. Bonate, PhD, FCP
Genzyme Corporation
Senior Director
Clinical Pharmacology and Pharmacokinetics
4545 Horizon Hill Blvd
San Antonio, TX 78229 USA
phone: 210-949-8662
fax: 210-949-8219
crackberry: 210-315-2713
"Beware of geeks bearing formulas". Written by Warren Buffet as part of =
Berkshire Hathaway's 2009 Annual Report to Stockholders.

Received on Thu Apr 23 2009 - 11:02:41 EDT

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