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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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Real-world prescription of anti-COVID-19 drugs in hospitalized patients with COVID-19 in Japan

PloS one, 2024-01, Vol.19 (1), p.e0297679-e0297679

2024

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Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies

Therapeutic innovation & regulatory science, 2024-07, Vol.58 (4), p.714-720

2024

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Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

Nature reviews. Drug discovery, 2013-02, Vol.12 (2), p.103-115

2013

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Establishment of the MID‐NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan

Pharmacoepidemiology and drug safety, 2019-10, Vol.28 (10), p.1395-1404

2019

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Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia

Therapeutic innovation & regulatory science, 2022-05, Vol.56 (3), p.523-529

2022

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The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan

Pharmacoepidemiology and drug safety, 2016-07, Vol.25 (7), p.854-859

2016

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Atypical Antipsychotics and the Risk of Hyperlipidemia: A Sequence Symmetry Analysis

Drug safety, 2015-07, Vol.38 (7), p.641-650

2015

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Risk of neutropenia in psoriasis patients prescribed anti-IL-23 antibody in comparison with anti-IL-17 antibody or adalimumab based on real-world data from the MID-NET ® in Japan

The Journal of dermatological treatment, 2024-12, Vol.35 (1), p.2373826

2024

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Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

Therapeutic innovation & regulatory science, 2023, Vol.57 (1), p.37-47

2023

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Correction: Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

Therapeutic innovation & regulatory science, 2023, Vol.57 (1), p.48-48

2023

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Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan

Therapeutic innovation & regulatory science, 2023-11, Vol.57 (6), p.1298-1303

2023

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Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis

Therapeutic innovation & regulatory science, 2021-09, Vol.55 (5), p.1075-1081

2021

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Cardiovascular risk of urate‐lowering drugs: A study using the National Database of Health Insurance Claims and Specific Health Checkups of Japan

Clinical and translational science, 2023-02, Vol.16 (2), p.206-215

2023

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Identification of gastrointestinal perforation based on ICD‐10 code in a Japanese administrative medical information database and associated drug exposure risk factors

Pharmacoepidemiology and drug safety, 2019-07, Vol.28 (7), p.976-984

2019

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Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials

British journal of clinical pharmacology, 2019-06, Vol.85 (6), p.1270-1282

2019

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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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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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Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan

Journal of human genetics, 2013-06, Vol.58 (6), p.313-316

2013

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Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET® Medical Information Database Network in Japan

Therapeutic innovation & regulatory science, 2022-07, Vol.56 (4), p.625-631

2022

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Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan

Therapeutic innovation & regulatory science, 2024-07, Vol.58 (4), p.746-755

2024

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Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia

Clinical and translational science, 2017-11, Vol.10 (6), p.503-508

2017

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Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan

Therapeutic innovation & regulatory science, 2021-05, Vol.55 (3), p.539-544

2021

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Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data

Therapeutic innovation & regulatory science, 2021-05, Vol.55 (3), p.523-538

2021

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Similarities and Differences between US and Japan as to Pharmacogenomic Biomarker Information in Drug Labels

DRUG METABOLISM AND PHARMACOKINETICS, 2012, Vol.27 (1), p.142-149

2012

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

Real-world prescription of anti-COVID-19 drugs in hospitalized patients with COVID-19 in Japan

Different Development Strategies Affecting Japan’s Drug lag between Japan-Based and Foreign-Based Companies

Pharmacogenetics in the evaluation of new drugs: a multiregional regulatory perspective

Establishment of the MID‐NET® medical information database network as a reliable and valuable database for drug safety assessments in Japan

Potential Future Drug Development Lag in Japan Based on an Analysis of Multiregional Clinical Trials in the US, Europe, and East Asia

The MIHARI project: establishing a new framework for pharmacoepidemiological drug safety assessments by the Pharmaceuticals and Medical Devices Agency of Japan

Atypical Antipsychotics and the Risk of Hyperlipidemia: A Sequence Symmetry Analysis

Risk of neutropenia in psoriasis patients prescribed anti-IL-23 antibody in comparison with anti-IL-17 antibody or adalimumab based on real-world data from the MID-NET ® in Japan

Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

Correction: Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

Characteristics of Asian Participation in Multi-regional Clinical Trials Reviewed for Drug Approval in Japan: Opportunities for Collaboration Between South-East Asia, East Asia, and Japan

Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis

Cardiovascular risk of urate‐lowering drugs: A study using the National Database of Health Insurance Claims and Specific Health Checkups of Japan

Identification of gastrointestinal perforation based on ICD‐10 code in a Japanese administrative medical information database and associated drug exposure risk factors

Population/regional differences in efficacy of 3 drug categories (antidiabetic, respiratory and psychotropic agents) among East Asians: A retrospective study based on multiregional clinical trials

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

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

Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan

Assessing the Risk of Decrease in Kidney Function in Patients Prescribed Direct-Acting Antivirals for Hepatitis C Utilizing the MID-NET® Medical Information Database Network in Japan

Detection Algorithms for Gastrointestinal Perforation Cases in the Medical Information Database Network (MID-NET®) in Japan

Current Status and Open Issues Concerning Global Clinical Trials (GCTs) in Japan and East Asia

Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET®) in Japan

Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data

Similarities and Differences between US and Japan as to Pharmacogenomic Biomarker Information in Drug Labels

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