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Clinical Chemistry 44: 381-387, 1998;
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(Clinical Chemistry. 1998;44:381-387.)
© 1998 American Association for Clinical Chemistry, Inc.

TDM Conference

Prospective investigations of concentration–clinical response for immunosuppressive drugs provide the scientific basis for therapeutic drug monitoring

Leslie M. Shaw1,a, Bruce Kaplan3, and Kenneth L. Brayman2

Departments of
1 Pathology & Laboratory Medicine and
2 Surgery, University of Pennsylvania Medical Center, Philadelphia, PA 19104.
3 St. Barnabas Medical Center, Livingston, NJ.
a Author for correspondence. Fax 215-662-7529; e-mail shawlmj{at}mail.med.upenn.edu.


Abstract

The performance of prospective concentration–clinical response investigations during the early stages of the development of new therapeutic agents can provide a more rigorous basis for therapeutic drug monitoring than the traditional retrospective review of drug concentrations vs clinical outcome. Here we discuss the application of the multicenter randomized concentration-controlled clinical trial study design, and related study designs, as applied to older commonly used and monitored drugs and to two new immunosuppressant drugs, mycophenolate mofetil and tacrolimus. Such studies can provide a more rigorous basis for assessing the risk/benefit associated with a target drug concentration in the individual patient and for designing future prospective pharmacokinetic and therapeutic drug monitoring investigations.




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[Abstract] [Full Text] [PDF]


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