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Average parameters in bioavailability studies: an application to slow-release amitriptyline formulation

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Summary

In order to assess the extent and the rate of absorption in bioavailability studies, area under the curve (AUC), experimental maximum concentration (Cmax) and experimental time to reach Cmax (Tmax), are used. But when slow-release formulations are considered, the drug concentration-time curves usually show multiple peaks, and it is difficult to compute a Cmax and Tmax value. In case a Cmax value is computed, important variability in this parameter results in high values in the residual variance of the ANOVA test. So in order to decrease the high variability, average parameters: average concentration (Cav), average maximum concentration (Cmax,av) and Cmax,av x 100/Cav (%Cmax,av), are proposed.

These new parameters were applied in a bioavailability study of slow-release amitriptyline formulation.

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Authors and Affiliations

  1. Department of Pharmacology and Biopharmacy, Faculty of Chemistry, CC 1157, 11800, Montevideo, Uruguay

    P. Fagiolino, M. Vázquez, E. Savio & L. Domínguez

  2. Department of Biopharmacy, Faculty of Pharmacy, Clermont-Ferrand, France

    J. M. Aiache & E. Beyssac

Authors
  1. P. Fagiolino
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  2. M. Vázquez
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  3. E. Savio
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  4. L. Domínguez
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  5. J. M. Aiache
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  6. E. Beyssac
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Fagiolino, P., Vázquez, M., Savio, E. et al. Average parameters in bioavailability studies: an application to slow-release amitriptyline formulation. European Journal of Drug Metabolism and Pharmacokinetics 23, 160–165 (1998). https://doi.org/10.1007/BF03189333

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  • DOI: https://doi.org/10.1007/BF03189333

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