Applications and prospects for physiologically based pharmacokinetic (PB-PK) models involving pharmaceutical agents

Toxicology Letters
H SuzukiY Sugiyama

Abstract

Because of the increasing availability of human liver samples, we are now able to predict in vivo drug disposition in man from in vitro metabolic and binding studies. In this report, we summarize successful attempts to predict in vivo metabolic clearances in animals and humans from in vitro biochemical parameters, using physiologically based pharmacokinetic models. There are still some problems, however, in extrapolating in vivo hepatic metabolism in man from in vitro data obtained using human liver specimens, due to (1) large interindividual differences resulting from genetic polymorphism and/or (2) differences in enzyme activities depending upon the conditions under which liver specimens may have been kept. We propose a possible method to overcome these difficulties by applying the concept of a 'scaling factor'. In addition, we also review several additional factors which should be considered to help achieve more reliable predictions.

References

Apr 15, 1988·Biochemical Pharmacology·L Bass, S Keiding
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Citations

Jan 1, 1997·Pharmacology & Therapeutics·T IwatsuboY Sugiyama
Jun 7, 2000·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·L P Balant, M Gex-Fabry
May 11, 1999·Alcoholism, Clinical and Experimental Research·V A RamchandaniS O'Connor
Sep 23, 2008·Journal of Pharmaceutical Sciences·Jong Hwan SungMichael L Shuler
Dec 25, 2004·Drug Metabolism and Pharmacokinetics·Noriko MatsunagaEmi Nakashima
Jun 14, 2021·European Journal of Drug Metabolism and Pharmacokinetics·Renu SinghDanica Stanimirovic

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