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Related Experiment Videos

Dosage regimen design: pharmacodynamic considerations.

R L Williams1

  • 1Office of Generic Drugs, Center for Drug Evaluation and Research, Rockville, Maryland 20857.

Journal of Clinical Pharmacology
|July 1, 1992
PubMed
Summary
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Pharmacokinetic and pharmacodynamic (PK/PD) models are established, but challenges remain in clinical drug development. Barriers include assay issues, inaccessible fluids, and difficulty linking immediate effects to long-term benefits for effective drug therapy.

Area of Science:

  • Pharmacology
  • Drug Development
  • Clinical Therapeutics

Background:

  • Pharmacokinetic (PK) methodology and concentration-effect models are well-established.
  • Non-steady-state PK/PD models can be used when steady-state conditions are unavailable.
  • Clinical drug development and therapy face limitations in PK/PD scrutiny.

Purpose of the Study:

  • To identify and discuss barriers to PK/PD scrutiny in clinical drug development.
  • To propose key questions for evaluating drug effects and their relationship to concentration.
  • To guide the application of PK/PD principles in therapeutic drug monitoring.

Main Methods:

  • Review of established PK/PD methodologies.
  • Identification of practical challenges in applying PK/PD models clinically.

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  • Formulation of a guiding question framework for drug evaluation.

    • Main Results:

    • Barriers include drug assay limitations, lack of accessible biological fluids, and absence of immediate clinical effects relatable to concentration.
    • Difficulty in linking immediate pharmacologic effects to long-term clinical benefits poses a significant challenge.
    • A structured set of questions is proposed to aid in assessing the suitability of PK/PD analysis for specific drugs.

    Conclusions:

    • Despite methodological advances, practical barriers hinder the widespread application of PK/PD in clinical drug development.
    • Careful consideration of drug effects, measurement feasibility, and concentration-effect relationships is crucial.
    • The proposed questions can facilitate better decision-making regarding drug dosimetry and therapeutic strategies.