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Cited by 29Pharmacogenetics and Drug MetabolismPharmaceutical studies and practicesAnimal testing and alternatives

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Prediction of Clearance in Humans from In Vitro Human Liver Microsomes and Allometric Scaling. A Comparative Study of the Two Approaches

Mahmood,, I.·2002·Drug Metabolism and Drug Interactions
DOI 10.1515/dmdi.2002.19.1.49
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Abstract

The objective of this study was to evaluate whether the predicted clearance of a drug in humans from in vitro human liver microsomes was comparable with the predicted clearance in humans obtained by allometric scaling. Sixteen drugs were randomly selected from the literature and their hepatic clearances were predicted using human liver microsomes. For allometric scaling at least three animal species were used and three methods were utilized to generate allometric equations to predict the clearance in humans: (i) clearance vs body weight (simple allometry); (ii) product of the clearance and maximum life-span potential (MLP) vs body weight; and (iii) the product of clearance and brain weight vs body weight. The choice of one of the methods was based on the 'rule of exponents' as described by Mahmood and Balian /2,3/. The results of this study indicated that the use of human liver microsomes to predict hepatic clearance in humans may not provide reliable predictions. On the other hand, the prediction of clearance in humans using allometric scaling combined with the 'rule of exponents' can provide comparatively better prediction of clearance in humans.

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References 47 · Cited by 29

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Metadata

Authors
Mahmood
Affiliations
Center for Biologics Evaluation and Research (US)
Corresponding author
Mahmood,, I.
ORCID
Mahmood,, I.
Venue
Drug Metabolism and Drug Interactions
Publisher
Walter de Gruyter GmbH
Published
2002-09
Volume
19
Issue
1
Pages
49-64
ISSN
  • 0334-2190 (ISSN-L)
  • 2191-0162
  • 0792-5077
DOI
10.1515/dmdi.2002.19.1.49
OpenAlex
W2315133816
Cited by
29
References
47
Citations by year
2024: 1 · 2019: 1 · 2018: 1 · 2017: 1 · 2015: 2 · 2014: 1 · 2012: 3
FWCI
1.02
Type
journal article
Language
en
Open access
closed
Locations
  • Drug metabolism and drug interactions (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
  • Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
Keywords
human liver microsomes, allometric scaling, brain weight, body weight, in vitro-in vivo extrapolation, drug metabolism
MeSH terms
Animals, Biometry, Body Weight, Brain, Humans, Life Expectancy, Metabolic Clearance Rate, Microsomes, Liver, Models, Chemical, Organ Size, Pharmacokinetics, In Vitro Techniques

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