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Dose-finding studies in clinical drug development

Summary

A correct dose-finding study is of the utmost importance during clinical development of a new drug. It must define the no-effect dose and the mean effective and maximal effective doses. Then taking tolerability into account, the optimal therapeutic dose range can be selected.

To define the dosage schedule the duration of action in man must be tested, if possible together with blood concentration measurements. An adequate dose-finding study shows the optimal doses for double-blind trials in Phase II and large scale trials in Phase III, thereby saving time and effort and reducing the number of patients required.

The tendency of clinical experts to try to demonstrate superiority of one drug over another by using doses higher than patients really need must be resisted. The price paid in poor tolerability exceeds any potential benefits.

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References

  1. U.S. Department of Health, Education, and Welfare, Public Health Service, Food and Drug Administration (1977) No. 77-3040. General Considerations for the Clinical Evaluation of Drugs. Washington DC 20402

  2. Greenwood DT, Todd AH (1977) From laboratory to clinical use. In: Johnson FN and Johnson S (eds) Clinical Trials. Blackwell Oxford, London, Edinburgh

    Google Scholar 

  3. Temple R (1982) Government viewpoint of clinical trials. Drug Information J 82: 10–17

    Google Scholar 

  4. Dengler HJ (1973) Early human trials: Selection of investigators and subjects. In: Clinical pharmacological evaluation in drug control. Report on a Symposium, Heidelberg, Nov 72 WHO (ed). Copenhagen, pp 29–36

    Google Scholar 

  5. World Medical Association Inc (1975) Declaration of Helsinki, Tokyo, Japan. Fed Reg 40, p 16056

    Google Scholar 

  6. Arpaillange P, Dion S, Mathé G (1986) Proposals for ethical standards in therapeutic trials with humans. Drugs Exp Clin Res 12: 11–19

    Google Scholar 

  7. Schmidt R (1987) Klinische Pharmakologie in der Pharmaindustrie — Möglichkeiten und Grenzen. In: Magometschnigg D (ed) Therapieversuch am Menschen. Uhlen-Verlagsgesellschaft, Wien

    Google Scholar 

  8. Schmidt R (1978) Nicht-invasive Methoden in der klinischen Pharmakologie. Medita 8: 48–49

    Google Scholar 

  9. Spiegel R, Aebi HJ (1983) Effects of psychopharmaceuticals on sleep polygrams. In: Psychopharmacology — An introduction. Wiley, Chichester

    Google Scholar 

  10. Godwey CW (1983) A guide to the pharmacology of placebos. Can Med Assoc J 128: 921–925

    Google Scholar 

  11. Simon P, Mery C (1985) Détermination de la posologie optimum. In: Pour une meilleure appréciation de la posologie optimale des médicaments. Therapie 37: 679–687

    Google Scholar 

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Scmidt, R. Dose-finding studies in clinical drug development. Eur J Clin Pharmacol 34, 15–19 (1988). https://doi.org/10.1007/BF01061410

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  • DOI: https://doi.org/10.1007/BF01061410

Key words

  • dose-finding
  • drug development
  • clinical trial
  • therapeutic dose range
  • proposed procedure
  • dose optimisation