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Prediction of the volume of distribution of 7-hydroxycoumarin in man from in vitro and ex vivo data obtained in rat

✍ Scribed by W. A. Ritschel; R. D. Johnson; N. N. Vachharajani; A. S. Hussain

Publisher
John Wiley and Sons
Year
1992
Tongue
English
Weight
661 KB
Volume
13
Category
Article
ISSN
0142-2782

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✦ Synopsis

Abstract

The essential parameter to estimate the first dose size of a drug in man is the volume of distribution. For a drug that has never been used in man before, estimates of the volume of distribution can only be obtained from animals and in vitro data. The purpose of this study was to compare various approaches presented in the literature for predicting the volume of distribution at steady state (V~SS~) and the terminal phase volume of distribution (V~dΞ²~) in man. A lipophilic active metabolite of coumarin, 7‐hydroxycoumarin (7OHC), was selected for this investigation. This compound is extensively metabolized in both the central and peripheral compartments. Of the six methods evaluated, only an empirical allometric approach yielded a reasonable estimate of V~SS~. All methods underestimated V~SS~ and none of the applicable methods were able to predict V~dΞ²~. The reason for this discrepancy may be due to the fact that the calculation of Kss in man was done assuming elimination from the central compartment.

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