ReviewClinical pharmacokinetics1999
Prediction of hepatic metabolic clearance based on interspecies allometric scaling techniques and in vitro-in vivo correlations.
Review in Clinical pharmacokinetics, 1999. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
39 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Allometry of factor VIII and informed scaling of next-generation therapeutic proteins.Journal of pharmaceutical sciences · 2013Pooled it
- Pharmacokinetics of the protease inhibitor indinavir in human immunodeficiency virus type 1-infected children.Antimicrobial agents and chemotherapy · 2001Trial
- Data set of fraction unbound values in the in vitro incubations for metabolic studies for better prediction of human clearance.Database : the journal of biological databases and curation · 2024Article
- Preclinical Pharmacokinetics and Translational Pharmacokinetic/Pharmacodynamic Modeling of M8891, a Potent and Reversible Inhibitor of Methionine Aminopeptidase 2.Pharmaceutical research · 2023Article
- Application of the Population Pharmacokinetics Model-Based Approach to the Prediction of Drug-Drug Interaction between Rivaroxaban and Carbamazepine in Humans.Pharmaceuticals (Basel, Switzerland) · 2023Article
- Application of an Inter-Species Extrapolation Method for the Prediction of Drug Interactions between Propolis and Duloxetine in Humans.International journal of molecular sciences · 2020Article
- Building and Applying Quantitative Adverse Outcome Pathway Models for Chemical Hazard and Risk Assessment.Environmental toxicology and chemistry · 2019Review
- Interpretation of Non-Clinical Data for Prediction of Human Pharmacokinetic Parameters: In Vitro-In Vivo Extrapolation and Allometric Scaling.Pharmaceutics · 2019Review
- Quantitative Prediction of Human Hepatic Clearance for P450 and Non-P450 Substrates from In Vivo Monkey Pharmacokinetics Study and In Vitro Metabolic Stability Tests Using Hepatocytes.The AAPS journal · 2019Article
- Research tools for extrapolating the disposition and pharmacokinetics of nanomaterials from preclinical animals to humans.Theranostics · 2019Review
- Novel in vitro dynamic metabolic system for predicting the human pharmacokinetics of tolbutamide.Acta pharmacologica Sinica · 2018Article
- Virtual population pharmacokinetic using physiologically based pharmacokinetic model for evaluating bioequivalence of oral lacidipine formulations in dogs.Asian journal of pharmaceutical sciences · 2017Article
- M2698 is a potent dual-inhibitor of p70S6K and Akt that affects tumor growth in mouse models of cancer and crosses the blood-brain barrier.American journal of cancer research · 2016Article
- Across-Species Scaling of Monoclonal Antibody Pharmacokinetics Using a Minimal PBPK Model.Pharmaceutical research · 2015Article
- A Multifaceted GABAA Receptor Modulator: Functional Properties and Mechanism of Action of the Sedative-Hypnotic and Recreational Drug Methaqualone (Quaalude).Molecular pharmacology · 2015Article
- Quantifying and Communicating Uncertainty in Preclinical Human Dose-Prediction.CPT: pharmacometrics & systems pharmacology · 2015Article
- Pharmacokinetics and interspecies allometric scaling of ST-246, an oral antiviral therapeutic for treatment of orthopoxvirus infection.PloS one · 2013Article
- In vitro to in vivo extrapolation and species response comparisons for drug-induced liver injury (DILI) using DILIsym™: a mechanistic, mathematical model of DILI.Journal of pharmacokinetics and pharmacodynamics · 2012Article
- The liver partition coefficient-corrected inhibitory quotient and the pharmacokinetic-pharmacodynamic relationship of directly acting anti-hepatitis C virus agents in humans.Antimicrobial agents and chemotherapy · 2012Article
- Applications of human pharmacokinetic prediction in first-in-human dose estimation.The AAPS journal · 2012Review
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
This article reviews the methods available for predicting hepatic metabolic clearance in humans, and discusses their application to the processes of drug discovery and development. The application of these techniques has increased markedly during the past few years because of the improved availability of human liver samples, which has increased the opportunities to use in vitro studies to predict human clearance. The techniques available involve both empirical and physiologically based approaches. Allometric scaling using in vitro data from animals and humans combines certain aspects of both approaches. An evaluation of data retrieved from the literature indicates that, together with in vitro human data, allometric scaling based on a combination of in vitro and in vivo preclinical data can accurately predict clearance in humans. With this approach, 80% of the predictions were within a 2-fold factor of actual human clearance values, with an overall accuracy of 1.6-fold. The uncertainties and inaccuracies in predicting human clearance are related to: (i) the specific method that is used to make the prediction; (ii) the experimental design and the model used to determine the in vitro clearance; (iii) protein binding within the in vitro test system; and (iv) various in vivo factors such as the involvement of extrahepatic metabolism and active transport processes, interindividual variability and nonlinearity in pharmacokinetics. In contrast to purely empirical approaches, the physiological approach to predicting clearance gives an opportunity to integrate some of these complexities and, therefore, should provide more confidence in the prediction of clearance in humans.
Indexed as
Identifiers
10223169What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.