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Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts

Biological and Pharmaceutical Bulletin, 2024/03/13, Vol.47(3), pp.611-619

2024

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Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model

Therapeutic innovation & regulatory science, 2024-03, Vol.58 (2), p.357-367

2024

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Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost

Regulatory toxicology and pharmacology, 2021-10, Vol.125, p.105019, Article 105019

2021

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Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan

Clinical pharmacology and therapeutics, 2021-06, Vol.109 (6), p.1555-1563

2021

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Applications of a grid-based CYP3A4 Template system to understand the interacting mechanisms of large-size ligands; part 4 of CYP3A4 Template study

Drug metabolism and pharmacokinetics, 2020-12, Vol.35 (6), p.485-496

2020

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Comparison of the developmental/reproductive toxicity and hepatotoxicity of phthalate esters in rats using an open toxicity data source

The Journal of Toxicological Sciences, 2019, Vol.44(4), pp.245-255

2019

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Comparison of Efficacy and Safety of Direct Oral Anticoagulants and Warfarin between Patients in Asian and Non‐Asian Regions: A Systematic Review and Meta‐Regression Analysis

Clinical pharmacology and therapeutics, 2023-06, Vol.113 (6), p.1240-1250

2023

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Reconstitution of CYP3A4 active site through assembly of ligand interactions as a grid-template: Solving the modes of the metabolism and inhibition

Drug metabolism and pharmacokinetics, 2019-04, Vol.34 (2), p.113-125

2019

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Expression, mutation, and methylation of cereblon‐pathway genes at pre‐ and post‐lenalidomide treatment in multiple myeloma

Cancer science, 2020-04, Vol.111 (4), p.1333-1343

2020

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Versatile applicability of a grid-based CYP3A4 Template to understand the interacting mechanisms with the small-size ligands; part 3 of CYP3A4 Template study

Drug metabolism and pharmacokinetics, 2020-06, Vol.35 (3), p.253-265

2020

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BRAF/MEK inhibitor-associated nephrotoxicity in a real-world setting and human kidney cells

Anti-cancer drugs, 2021-11, Vol.32 (10), p.1076-1083

2021

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Solving the interactions of steroidal ligands with CYP3A4 using a grid-base template system

Drug metabolism and pharmacokinetics, 2019-12, Vol.34 (6), p.351-364

2019

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Significant association between HLA‐B35:01 and onset of drug‐induced liver injury caused by Kampo medicines in Japanese patients

Hepatology research, 2023-05, Vol.53 (5), p.440-449

2023

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HLA‐B1511 is a risk factor for carbamazepine‐induced Stevens‐Johnson syndrome and toxic epidermal necrolysis in Japanese patients

Epilepsia (Copenhagen), 2010-12, Vol.51 (12), p.2461-2465

2010

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Cross-Classification of Human Urinary Lipidome by Sex, Age, and Body Mass Index

PloS one, 2016-12, Vol.11 (12), p.e0168188-e0168188

2016

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Serum lipidomics for exploring biomarkers of bortezomib therapy in patients with multiple myeloma

Cancer science, 2019-10, Vol.110 (10), p.3267-3274

2019

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In Silico Prediction of Chemical-Induced Hepatocellular Hypertrophy Using Molecular Descriptors

Toxicological sciences, 2018-04, Vol.162 (2), p.667-675

2018

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In Silico Approach to Predict Severe Cutaneous Adverse Reactions Using the Japanese Adverse Drug Event Report Database

Clinical and translational science, 2021-03, Vol.14 (2), p.756-763

2021

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Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians

British journal of clinical pharmacology, 2016-06, Vol.81 (6), p.1078-1090

2016

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Targeted Disruption of the Nuclear Receptor FXR/BAR Impairs Bile Acid and Lipid Homeostasis

Cell, 2000-09, Vol.102 (6), p.731-744

2000

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Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents

Drug metabolism and pharmacokinetics, 2020-04, Vol.35 (2), p.187-190

2020

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Factors Affecting Drug‐Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan

Clinical and translational science, 2018-03, Vol.11 (2), p.182-188

2018

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HLA genotyping in Japanese patients with multiple myeloma receiving bortezomib: An exploratory biomarker study of JCOG1105 (JCOG1105A1)

Cancer science, 2021-12, Vol.112 (12), p.5011-5019

2021

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Comparison of Efficacy of Dipeptidyl Peptidase‐4 Inhibitors and Sodium‐Glucose Co‐Transporter 2 Inhibitors Between Japanese and Non‐Japanese Patients: A Meta‐Analysis

Clinical and translational science, 2020-05, Vol.13 (3), p.498-508

2020

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Identification of the functional vitamin D response elements in the human MDR1 gene

Biochemical pharmacology, 2008-08, Vol.76 (4), p.531-542

2008

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Streamlining Considerations for Safety Measures: A Predictive Model for Addition of Clinically Significant Adverse Reactions to Japanese Drug Package Inserts

Predicting the Addition of Information Regarding Clinically Significant Adverse Drug Reactions to Japanese Drug Package Inserts Using a Machine-Learning Model

Development of quantitative model of a local lymph node assay for evaluating skin sensitization potency applying machine learning CatBoost

Points to Consider for Implementation of the ICH E17 Guideline: Learning from Past Multiregional Clinical Trials in Japan

Applications of a grid-based CYP3A4 Template system to understand the interacting mechanisms of large-size ligands; part 4 of CYP3A4 Template study

Comparison of the developmental/reproductive toxicity and hepatotoxicity of phthalate esters in rats using an open toxicity data source

Comparison of Efficacy and Safety of Direct Oral Anticoagulants and Warfarin between Patients in Asian and Non‐Asian Regions: A Systematic Review and Meta‐Regression Analysis

Reconstitution of CYP3A4 active site through assembly of ligand interactions as a grid-template: Solving the modes of the metabolism and inhibition

Expression, mutation, and methylation of cereblon‐pathway genes at pre‐ and post‐lenalidomide treatment in multiple myeloma

Versatile applicability of a grid-based CYP3A4 Template to understand the interacting mechanisms with the small-size ligands; part 3 of CYP3A4 Template study

BRAF/MEK inhibitor-associated nephrotoxicity in a real-world setting and human kidney cells

Solving the interactions of steroidal ligands with CYP3A4 using a grid-base template system

Significant association between HLA‐B35:01 and onset of drug‐induced liver injury caused by Kampo medicines in Japanese patients

HLA‐B1511 is a risk factor for carbamazepine‐induced Stevens‐Johnson syndrome and toxic epidermal necrolysis in Japanese patients

Cross-Classification of Human Urinary Lipidome by Sex, Age, and Body Mass Index

Serum lipidomics for exploring biomarkers of bortezomib therapy in patients with multiple myeloma

In Silico Prediction of Chemical-Induced Hepatocellular Hypertrophy Using Molecular Descriptors

In Silico Approach to Predict Severe Cutaneous Adverse Reactions Using the Japanese Adverse Drug Event Report Database

Absence of ethnic differences in the pharmacokinetics of moxifloxacin, simvastatin, and meloxicam among three East Asian populations and Caucasians

Targeted Disruption of the Nuclear Receptor FXR/BAR Impairs Bile Acid and Lipid Homeostasis

Clinical study designs and patient selection methods based on genomic biomarkers: Points-to-consider documents

Factors Affecting Drug‐Development Strategies in Asian Global Clinical Trials for Drug Approval in Japan

HLA genotyping in Japanese patients with multiple myeloma receiving bortezomib: An exploratory biomarker study of JCOG1105 (JCOG1105A1)

Comparison of Efficacy of Dipeptidyl Peptidase‐4 Inhibitors and Sodium‐Glucose Co‐Transporter 2 Inhibitors Between Japanese and Non‐Japanese Patients: A Meta‐Analysis

Identification of the functional vitamin D response elements in the human MDR1 gene

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