Trial reportArchives of pharmacal research2021
Physiologically based pharmacokinetic (PBPK) modelling of tamsulosin related to CYP2D6*10 allele.
Trial report in Archives of pharmacal research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.
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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
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Who cites it
12 citing papers in PubMed.
- Development and Evaluation of Physiologically Based Pharmacokinetic (PBPK) Models to Investigate the Effect of CYP2D6 Polymorphism on Metoclopramide Systemic Exposure.Pharmaceuticals (Basel, Switzerland) · 2026Article
- Effects of fluconazole on the pharmacokinetics of celecoxib and its carboxylic acid metabolite in different CYP2C9 genotypes.Archives of pharmacal research · 2025Article
- Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry.Pharmaceutics · 2024Review
- Physiologically based pharmacokinetic (PBPK) modeling of pitavastatin in relation to SLCO1B1 genetic polymorphism.Archives of pharmacal research · 2024Article
- PBPK modeling to predict the pharmacokinetics of pantoprazole in different CYP2C19 genotypes.Archives of pharmacal research · 2024Article
- Physiologically based pharmacokinetic (PBPK) modeling to predict the pharmacokinetics of irbesartan in different CYP2C9 genotypes.Archives of pharmacal research · 2023Article
- Effects of CYP2D6 and CYP2C19 genetic polymorphisms and cigarette smoking on the pharmacokinetics of tolperisone.Archives of pharmacal research · 2023Article
- Effects of CYP2C9 and CYP2C19 genetic polymorphisms on the pharmacokinetics and pharmacodynamics of gliclazide in healthy subjects.Archives of pharmacal research · 2023Article
- Article
- Physiologically based pharmacokinetic (PBPK) modeling of flurbiprofen in different CYP2C9 genotypes.Archives of pharmacal research · 2022Article
- Physiologically based pharmacokinetic modelling to predict the pharmacokinetics of metoprolol in different CYP2D6 genotypes.Archives of pharmacal research · 2022Article
- Physiologically based pharmacokinetic (PBPK) modeling of piroxicam with regard to CYP2C9 genetic polymorphism.Archives of pharmacal research · 2022Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
Tamsulosin, a selective [Formula: see text]-adrenoceptor blocker, is commonly used for alleviation of lower urinary tract symptoms related to benign prostatic hyperplasia. Tamsulosin is predominantly metabolized by CYP3A4 and CYP2D6 enzymes, and several studies reported the effects of CYP2D6 genetic polymorphism on the pharmacokinetics of tamsulosin. This study aims to develop and validate the physiologically based pharmacokinetic (PBPK) model of tamsulosin in CYP2D6*wt/*wt, CYP2D6*wt/*10, and CYP2D6*10/*10 genotypes, using Simcyp® simulator. Physicochemical, and formulation properties and data for absorption, distribution, metabolism and excretion were collected from previous publications, predicted in the simulator, or optimized in different CYP2D6 genotypes. The tamsulosin PBPK model in CYP2D6*wt/*wt and CYP2D6*wt/*10 genotypes were developed based on the clinical pharmacokinetic study where a single oral dose of 0.2 mg tamsulosin was administered to 25 healthy Korean male volunteers with CYP2D6*wt/*wt and CYP2D6*wt/*10 genotypes. A previous pharmacokinetic study was used to develop the model in CYP2D6*10/*10 genotype. The developed model was validated using other clinical pharmacokinetic studies not used in development. The predicted exposures via the PBPK model in CYP2D6*wt/*10 and CYP2D6*10/*10 genotype was 1.23- and 1.76-fold higher than CYP2D6*wt/*wt genotype, respectively. The simulation profiles were visually similar to the observed profiles, and fold errors of all development and validation datasets were included within the criteria. Therefore, the tamsulosin PBPK model in different CYP2D6 genotypes with regards to CYP2D6*10 alleles was appropriately established. Our model can contribute to the implementation of personalized pharmacotherapy of patients, appropriately predicting the pharmacokinetics of tamsulosin reflecting their demographic and CYP2D6 genotype characteristics without unnecessary drug exposure.
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