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Dose-finding studies in clinical drug development.

R Schmidt1

  • 1Clinical Research Department, SANDOZ Ltd., Basel, Switzerland.

European Journal of Clinical Pharmacology
|January 1, 1988
PubMed
Summary
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Proper drug dose-finding studies are crucial for determining effective and safe therapeutic ranges. Identifying optimal doses early saves resources and patient numbers in clinical trials.

Area of Science:

  • Pharmacology
  • Clinical Drug Development

Background:

  • Accurate dose-finding is essential for new drug development.
  • Defining no-effect, effective, and maximal doses is critical.
  • Tolerability influences the selection of the optimal therapeutic dose range.

Purpose of the Study:

  • To outline the importance and methodology of correct dose-finding studies.
  • To emphasize the selection of optimal therapeutic dose ranges.
  • To guide dosage schedule determination through duration of action and blood concentration studies.

Main Methods:

  • Defining no-effect dose, mean effective dose, and maximal effective dose.
  • Assessing drug duration of action in humans and blood concentration.
  • Utilizing findings for Phase II and Phase III clinical trial dose selection.

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Main Results:

  • Adequate dose-finding studies optimize doses for subsequent clinical trials.
  • This approach saves time, effort, and reduces patient numbers.
  • Resisting the urge to use supra-therapeutic doses prevents poor tolerability.

Conclusions:

  • Correct dose-finding studies are fundamental for efficient and ethical drug development.
  • Optimal therapeutic dose selection balances efficacy and tolerability.
  • Prioritizing patient safety and resource management is paramount.