Prediction of human drug clearance from animal data: Application of the rule of exponents and ‘fu corrected intercept method’ (FCIM)
Abstract
The objective of this study is to evaluate the predictive performance of the rule of exponents (ROE) and 'fu Corrected Intercept Method' (FCIM) for the human drug clearance. Different classes of drugs such as extensively metabolized, renally excreted, renally secreted, and biliary excreted drugs were used in this analysis. The results of the study indicated that both these methods under given conditions are extremely useful for the prediction of human drug clearance. There are certain situations under which one of these methods is more suited than the other method. Overall, it appears that a rational use of FCIM and the ROE can help a great deal in obtaining a better estimate of the human drug clearance for a wide variety of drugs. The advantages and disadvantages of these two methods are also discussed.
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FCIM is not suitable for renally secreted and biliary excreted drugs.
“Furthermore, FCIM is not suitable for renally secreted and biliary excreted drugs.”
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 [106]
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“However, when Mahmood [106] performed comparative analysis using ROE and FCIM for drugs with various PK properties (i.”
MethodInfluentialMisconceptions and Issues Regarding Allometric Scaling during the Drug Development Process
Mahmood, I. (2018) · Expert Opinion on Drug Metabolism & Toxicology · doi:10.1080/17425255.2018.1499725 · Cited by 35 · see citing works
Self-citation
- Authors
- Mahmood, I.
- Affiliations
- United States Food and Drug Administration (US)
- Corresponding author
- Mahmood, Iftekhar
- ORCID
- Mahmood, Iftekhar
- Venue
- Journal of Pharmaceutical Sciences
- Publisher
- Elsevier BV
- Published
- 2006-08
- Volume
- 95
- Issue
- 8
- Pages
- 1810-1821
- ISSN
- 0022-3549 (ISSN-L)
- OpenAlex
- W2032849206
- Cited by
- 34
- References
- 0
- Citations by year
- 2026: 3 · 2023: 1 · 2022: 1 · 2020: 1 · 2019: 2 · 2018: 1 · 2017: 1 · 2016: 1 · 2015: 2 · 2014: 1 · 2012: 3
- FWCI
- 3.40
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Pharmaceutical Sciences (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Health Sciences › Veterinary › Small Animals › Animal testing and alternatives
- Keywords
- predictive performance
- MeSH terms
- Animals, Haplorhini, Dogs, Pharmaceutical Preparations, Humans, Metabolic Clearance Rate, Predictive Value of Tests, Rabbits, Species Specificity, Technology, Pharmaceutical, Databases, Factual, Mice, Rats
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