An Estimate of the Number of Hepatocyte Donors Required to Provide Reasonable Estimates of Human Hepatic Clearance from In Vitro Experiments

James Byers; Kenneth Bachmann; Heather Eng; Anand Katta; Donald White; Ritwik Ghosh; Nicola J. Hewitt; Paul Silber; Genfu Chen

doi:10.2174/187231207780363660

ISSN: 1872-3128
E-ISSN: 1874-0758

An Estimate of the Number of Hepatocyte Donors Required to Provide Reasonable Estimates of Human Hepatic Clearance from In Vitro Experiments
Authors: James Byers¹, Kenneth Bachmann², Heather Eng³, Anand Katta⁴, Donald White⁵, Ritwik Ghosh⁶, Nicola J. Hewitt⁷, Paul Silber⁸ and Genfu Chen⁹
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¹ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ² Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ³ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ⁴ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ⁵ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ⁶ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ⁷ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ⁸ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA. ⁹ Department of Pharmacology,The University of Toledo College of Pharmacy, 2801 W. Bancroft St.,Toledo, OH 43606, USA.
Source: Drug Metabolism Letters, Volume 1, Issue 2, Apr 2007, p. 91 - 95
DOI: https://doi.org/10.2174/187231207780363660
- Available online: 01 Apr 2007

Abstract

Cryopreserved human hepatocytes in suspension were used to estimate in vivo hepatic clearances for six different drugs. In vitro intrinsic clearances were measured on the basis of substrate depletion. The number of different hepatocyte donors required for a reasonable estimate of in vivo hepatic clearance-within twice or 1 / 2 of the actual value—was determined. Depending upon the desired level of confidence, anywhere from 9-20 donors are required by this method.

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2007-04-01

2025-10-11

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Article Type: Research Article

Keyword(s): clearance prediction; Cryopreserved hepatocytes; hepatocyte donors; intrinsic clearance

An Estimate of the Number of Hepatocyte Donors Required to Provide Reasonable Estimates of Human Hepatic Clearance from In Vitro Experiments

Abstract

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