Interspecies Scaling: Predicting Oral Clearance in Humans
Abstract
The objective of this study was to test the interspecies scaling approach for a wide variety of drugs to predict oral clearance in humans from animal data. This study is an attempt to evaluate whether the rule of exponents of Mahmood and Balian for the prediction of systemic clearance can also be applied for the prediction of oral clearance in humans. Three different methods were used to generate log-log plots to scale up the clearance values: (1) clearance versus body weight (simple allometric equation), (2) the product of clearance and maximum life-span potential (MLP) versus body weight, and (3) the product of clearance and brain weight versus body weight. Data from 32 drugs were analyzed, and it was concluded that the oral clearance of drugs could be best predicted using one of the allometric equations.
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The ROE also predicted oral clearance.
“Results showed that the ROE also predicted oral clearance.”
From Interpretation of Non-Clinical Data for Prediction of Human Pharmacokinetic Parameters: In Vitro-In Vivo Extrapolation and Allometric Scaling (2019) · cites this paper as [103]
Cites
Interspecies Scaling: Predicting Clearance of Drugs in Humans. Three Different Approaches
Mahmood, I., & Balian, J. D. (1996) · Xenobiotica · doi:10.3109/00498259609052491 · Cited by 257 · see citing works
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Shiran, M. R., Proctor, N. J., Howgate, E. M., Rowland-Yeo, K., Tucker, G. T., & Rostami-Hodjegan, A. (2006) · Xenobiotica · doi:10.1080/00498250600761662 · Cited by 89 · see citing works
Choi, G.-W., Lee, Y.-B., & Cho, H.-Y. (2019) · Pharmaceutics · doi:10.3390/pharmaceutics11040168 · Cited by 76 · see citing works
“Mahmood [103] also tested the ROE to predict oral clearance by the same approach.”
MethodMechan, A., Yuan, J., Hatzidimitriou, G., Irvine, R. J., McCann, U. D., & Ricaurte, G. A. (2006) · Neuropsychopharmacology · doi:10.1038/sj.npp.1300808 · Cited by 67 · see citing works
Phytochemicals in Alzheimer disease, the development of clinical trials
Quinn, J., Kaye, J., Montine, T., & Stackman, R. (2004) · Pharmaceutical Biology · doi:10.3109/138802090893531 · Cited by 8 · see citing works
- Authors
- Mahmood, I.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Mahmood, Iftekhar
- ORCID
- Mahmood, Iftekhar
- Venue
- American Journal of Therapeutics
- Published
- 2002-01
- Volume
- 9
- Issue
- 1
- Pages
- 35-42
- ISSN
- 1075-2765 (ISSN-L)
- OpenAlex
- W2034191582
- Cited by
- 33
- References
- 1
- Citations by year
- 2026: 1 · 2024: 1 · 2021: 1 · 2019: 1 · 2017: 1 · 2016: 1 · 2013: 3 · 2012: 2
- FWCI
- 2.42
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- American Journal of Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- interspecies scaling, oral clearance, allometric scaling, brain weight, body weight, drug clearance prediction, animal-to-human extrapolation
- MeSH terms
- Administration, Oral, Animals, Body Weight, Evaluation Studies as Topic, Humans, Life Expectancy, Mathematics, Metabolic Clearance Rate, Models, Biological, Organ Size, Pharmacokinetics, Species Specificity
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