SynthesisCPT: pharmacometrics & systems pharmacology2023
Model-based meta-analysis of ethnic differences and their variabilities in clearance of oral drugs classified by clearance mechanism.
Synthesis in CPT: pharmacometrics & systems pharmacology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.
- Model-based meta-analysis of ethnic differences and their variabilities in clearance of oral drugs classified by clearance mechanism.CPT: pharmacometrics & systems pharmacology · 2023Pooled it
- Pharmacokinetics, Tolerability, and Biomarker Profile of the Neurokinin 3 Receptor Antagonist Fezolinetant in Healthy Japanese Individuals: A 2-Part, Randomized, Phase 1 Study.Clinical pharmacology in drug development · 2025Trial
- Pharmacokinetics of Nirmatrelvir/Ritonavir after Multiple Administration in a Phase 1, Open-Label Study in Healthy Chinese Adults and Compared with Non-Chinese Participants.Clinical drug investigation · 2026Article
- Mitigate Japan's Drug Loss With Model-Informed Drug Development.CPT: pharmacometrics & systems pharmacology · 2025Article
- Evaluation of Characteristics and Ethnic Sensitivity for FDA-Approved Drugs with Racial and Ethnic Differences in Pharmacokinetics, Safety, and Efficacy.Journal of clinical pharmacology · 2025Article
- New Horizon in Clinical Development Strategy in Japan Based on New Guideline on Japanese Phase 1 Studies Prior to Multi-Regional Clinical Trials.Clinical and translational science · 2025Article
- Utilising Endogenous Biomarkers in Drug Development to Streamline the Assessment of Drug-Drug Interactions Mediated by Renal Transporters: A Pharmaceutical Industry Perspective.Clinical pharmacokinetics · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In this study, the ethnic ratios (ERs) of oral clearance between Japanese and Western populations were subjected to model-based meta-analysis (MBMA) for 81 drugs evaluated in 673 clinical studies. The drugs were classified into eight groups according to the clearance mechanism, and the ER for each group was inferred together with interindividual variability (IIV), interstudy variability (ISV), and inter-drug variability within a group (IDV) using the Markov chain Monte Carlo (MCMC) method. The ER, IIV, ISV, and IDV were dependent on the clearance mechanism, and, except for particular groups such as drugs metabolized by polymorphic enzymes or their clearance mechanism is not confirmative, the ethnic difference was found to be generally small. The IIV was well-matched across ethnicities, and the ISV was approximately half of the IIV as the coefficient of variation. To adequately assess ethnic differences in oral clearance without false detections, phase I studies should be designed with full consideration of the mechanism of clearance. This study suggests that the methodology of classifying drugs based on the mechanism that causes ethnic differences and performing MBMA with statistical techniques such as MCMC analysis is helpful for a rational understanding of ethnic differences and for strategic drug development.
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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.