Influence of Sample Size on the Results of Bioequivalence Studies

Authors

  • I. Zulić Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, B&H
  • J. Kusturica Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, B&H
  • D. Potkonjak
  • E. Kapić
  • N. Mulabegović
  • S. Loga-Zec Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, B&H
  • M. Rakanović-Todić Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, B&H
  • F. Bečić Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, B&H
  • S. Krošnjar Institute of Pharmacology, Clinical Pharmacology and Toxicology, Faculty of Medicine, University of Sarajevo, Sarajevo, B&H

DOI:

https://doi.org/10.5644/Radovi.352

Abstract

Great number of drugs coming from different manufactures is available on the market.

The bioequivalence studies give substantial evidence if these drugs, given in same doses and under similar conditions, have similar bioavailability. Studies of bioequivalence are performed on healthy young volunteers in crossover designs and artificially controlled environment to minimize factors, other than the drug, which can affect bioavailability. They usually include 24 healthy volunteers with about 20 blood analyzes giving a total of 500.

This kind of research is of big importance for the determination of pharmacokinetic drug characteristics but is very expensive, especially in small countries.

Considering the importance of cost decrement, we set the hypothesis that bioequivalence studies can be performed on smaller number of subjects. This hypothesis is confirmed by the results of our analysis (6) included in cross-over study can be an adequate number.

References

Holford, N. (2001): Clinical Pharmacokinetics and Pharmaco-dynamics: The Quantitative Basis for Therapeutics, in: Clinical Pharmacology Basic Principles in Therapeutics Ed: K. L. Mclmon, H.F. Morrelli, B.B. Hoffman, D.W. Nierenberg, Third Edition 37: 951-964.

Goodman and Gilman S. (1996): The Pharmacological Basis of Therapeutics, Ninth edition. Eds.: Hardman, J.G. and Limbird, L.E. McGraw-Hill, Health Professions Division 1-27.

CDER (2001): Guidance for Industry; Statistical Approach’s to Establishing Bioequivalence. US Department of Health and Human Services; Food and Drug Administration. Centre for Drug Evaluation and Research.

Spilker B. (1991): Guide to Clinical Trials. Raven Press, New York.

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Published

18.05.2003

Issue

Vol. 32 (2003): Radovi

Section

Works

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Copyright (c) 2026 I. Zulić, J. Kusturica, D. Potkonjak, E. Kapić, N. Mulabegović, S. Loga-Zec, M. Rakanović-Todić, F. Bečić, S. Krošnjar

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

How to Cite

Influence of Sample Size on the Results of Bioequivalence Studies. (2003). Acta Medica Academica, 32, 73-86. https://doi.org/10.5644/Radovi.352

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