15 Citations (Scopus)

Abstract

The development of a new drug is characterized by distinct developmental stages, usually described as phases I to IV. Dose tolerance and dose response exploration studies are undertaken in phase II or III. Pharmacokinetic studies are often involved in these phases, but frequently only as an objective of minor importance. The usefulness of therapeutic drug monitoring (TDM) is not consequently investigated for new drugs. Usually the need for TDM is only discovered much later, when the drug is already on the market. TDM is particularly valuable under the following circumstances: (i) if there is a stronger relationship between the drug concentration and effect than between the dose and effect; (ii) if there is no simple and clear clinical parameter available to evaluate the clinical efficacy of the drug; (iii) if the therapeutic window is small; (iv) to document interactions; (v) to monitor drug compliance; and (vi) if there is large intra- and interindividual variability and unpredictability in pharmacokinetic parameters. Our recommendation is that randomized concentration controlled trials should be performed during the early stages of drug development and that it should be obligatory for drug licensing. © 2008 Adis Data Information BV. All rights reserved.
Original languageEnglish
Pages (from-to)235-244
Number of pages10
JournalPharmaceutical Medicine
Volume22
Issue number4
Publication statusPublished - 1-Jan-2008

Keywords

  • Clinical trial design
  • Cost effectiveness
  • Drug monitoring
  • Pharmacokinetics
  • Research and development
  • amikacin
  • aminoglycoside
  • anticonvulsive agent
  • antifungal agent
  • antiinfective agent
  • antiretrovirus agent
  • caffeine
  • centoxin
  • clozapine
  • cyclosporin A
  • digoxin
  • immunosuppressive agent
  • methadone
  • serotonin uptake inhibitor
  • tetrahydrocannabinol
  • theophylline
  • tricyclic antidepressant agent
  • vancomycin
  • voriconazole
  • area under the curve
  • cerebrospinal fluid analysis
  • clinical effectiveness
  • clinical research
  • clinical trial
  • controlled clinical trial
  • cost effectiveness analysis
  • dose response
  • drug binding
  • drug blood level
  • drug cerebrospinal fluid level
  • drug clearance
  • drug distribution
  • drug hair level
  • drug half life
  • drug marketing
  • drug monitoring
  • drug saliva level
  • drug tolerability
  • drug urine level
  • expired air
  • eye disease
  • hair analysis
  • human
  • licensing
  • maximum plasma concentration
  • meconium
  • neurologic disease
  • patient compliance
  • pharmacodynamics
  • priority journal
  • review
  • saliva analysis
  • schizophrenia
  • sweat
  • time to maximum plasma concentration
  • urinalysis

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