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

Leslie M. Shaw, Bruce Kaplan, Kenneth L. Brayman

Research output: Contribution to journalArticle

37 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)381-387
Number of pages7
JournalClinical Chemistry
Volume44
Issue number2
StatePublished - Mar 9 1998

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical

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