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Lag Time for New Innovative, First-in-Class, Drug Approval in Japan

Biological and Pharmaceutical Bulletin, 2022/04/01, Vol.45(4), pp.477-482

2022

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The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States

Investigational new drugs, 2019-10, Vol.37 (5), p.1086-1093

2019

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Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan

Biological and Pharmaceutical Bulletin, 2023/05/01, Vol.46(5), pp.700-706

2023

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Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials

Pharmaceutical medicine, 2021-07, Vol.35 (4), p.253-260

2021

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Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan

Clinical therapeutics, 2018-02, Vol.40 (2), p.284-295

2018

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Health Technology Assessment in Japan: A Pharmaceutical Industry Perspective

Therapeutic innovation & regulatory science, 2019-07, Vol.53 (4), p.472-480

2019

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Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database

Therapeutic innovation & regulatory science, 2024-09, Vol.58 (5), p.831-837

2024

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Burden of caring for Alzheimer's disease or dementia patients in Japan, the US, and EU: results from the National Health and Wellness Survey: a cross-sectional survey

Journal of medical economics, 2021-01, Vol.24 (1), p.266-278

2021

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Alternative New Mono-scaled Quantitative Benefit–Risk Assessment of Human Papillomavirus Vaccine in Japan

Therapeutic innovation & regulatory science, 2021, Vol.55 (1), p.48-55

2021

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Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks

Clinical therapeutics, 2016-03, Vol.38 (3), p.574-581

2016

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A population-based study of the humanistic burden among cancer patients in Japan

Journal of medical economics, 2020-05, Vol.23 (5), p.429-441

2020

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New quantitative method for evaluation of motor functions applicable to spinal muscular atrophy

Brain & development (Tokyo. 1979), 2018-03, Vol.40 (3), p.172-180

2018

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HPVワクチンの一元的なベネフィット・リスク評価の確立

YAKUGAKU ZASSHI, 2022/12/01, Vol.142(12), pp.1399-1407

2022

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Weather Fluctuations May Have an Impact on Stroke Occurrence in a Society: A Population-Based Cohort Study

Cerebrovascular diseases extra, 2020-01, Vol.10 (1), p.1-10

2020

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Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework

Therapeutic innovation & regulatory science, 2019-07, Vol.53 (4), p.535-541

2019

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Preliminary Experience with Air Transfer of Patients for Rescue Endovascular Therapy after Failure of Intravenous Tissue Plasminogen Activator

Neurologia medico-chirurgica, 2015, Vol.55(3), pp.248-252

2015

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Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan

Journal of clinical pharmacy and therapeutics, 2022-09, Vol.47 (9), p.1395-1401

2022

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Clinical development of anticancer drugs can be enhanced using efficacy data of small population clinical trials

Journal of clinical pharmacy and therapeutics, 2022-09, Vol.47 (9), p.1388-1394

2022

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Characteristics of drugs approved in Japan without conducting confirmatory clinical trials

Journal of clinical pharmacy and therapeutics, 2021-12, Vol.46 (6), p.1582-1590

2021

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Establishment of Mono-scaled Benefit/Risk Analysis of HPV Vaccine

YAKUGAKU ZASSHI, 2022, pp.22-00142

2022

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Regional disparity in first-in-class anticancer drug development in the US, EU, and Japan

Biological and Pharmaceutical Bulletin, 2023, pp.b22-00868

2023

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Humanistic and economic burden among caregivers of patients with cancer in Japan

Journal of medical economics, 2020-01, Vol.23 (1), p.17-27

2020

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TOWARD BETTER CONDUCT OF MULTINATIONAL CLINICAL TRIALS: COMPARISON OF CLINICAL ASSESSMENT SCALES BY REGIONS (NORTH AMERICA AND JAPAN)

Alzheimer's & dementia, 2017-07, Vol.13 (7), p.P718-P718

2017

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Factors associated with humanistic burden and indirect cost among patients with cancer in Japan

Journal of medical economics, 2020-12, Vol.23 (12), p.1570-1578

2020

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Humanistic burden among caregivers of patients with Alzheimer's disease or dementia in Japan: a large-scale cross-sectional survey

Journal of medical economics, 2021-01, Vol.24 (1), p.181-192

2021

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Lag Time for New Innovative, First-in-Class, Drug Approval in Japan

The drug lag and associated factors for orphan anticancer drugs in Japan compared to the United States

Regional Disparity in First-in-Class Anticancer Drug Development in the US, EU, and Japan

Evaluation of Drug Lags in Development Initiation, New Drug Application and Approval Between Japan and the USA and the Impact of Local Versus Multi-regional Clinical Trials

Identification of Drug Characteristics for Implementing Multiregional Clinical Trials Including Japan

Health Technology Assessment in Japan: A Pharmaceutical Industry Perspective

Preventive Effects of Bioabsorbable Anti-Adhesion Barriers on Bowel Obstruction After Colectomy in Colon Cancer Patients: A Retrospective Cohort Study Using an Insurance Claims Database

Burden of caring for Alzheimer's disease or dementia patients in Japan, the US, and EU: results from the National Health and Wellness Survey: a cross-sectional survey

Alternative New Mono-scaled Quantitative Benefit–Risk Assessment of Human Papillomavirus Vaccine in Japan

Improvement of Pediatric Drug Development: Regulatory and Practical Frameworks

A population-based study of the humanistic burden among cancer patients in Japan

New quantitative method for evaluation of motor functions applicable to spinal muscular atrophy

HPVワクチンの一元的なベネフィット・リスク評価の確立

Weather Fluctuations May Have an Impact on Stroke Occurrence in a Society: A Population-Based Cohort Study

Future Perspectives for the Treatment of Diabetes: Importance of a Regulatory Framework

Preliminary Experience with Air Transfer of Patients for Rescue Endovascular Therapy after Failure of Intravenous Tissue Plasminogen Activator

Impact of expedited programs in the United States, as foreign regulatory factors, on clinical development time in Japan

Clinical development of anticancer drugs can be enhanced using efficacy data of small population clinical trials

Characteristics of drugs approved in Japan without conducting confirmatory clinical trials

Establishment of Mono-scaled Benefit/Risk Analysis of HPV Vaccine

Regional disparity in first-in-class anticancer drug development in the US, EU, and Japan

Humanistic and economic burden among caregivers of patients with cancer in Japan

TOWARD BETTER CONDUCT OF MULTINATIONAL CLINICAL TRIALS: COMPARISON OF CLINICAL ASSESSMENT SCALES BY REGIONS (NORTH AMERICA AND JAPAN)

Factors associated with humanistic burden and indirect cost among patients with cancer in Japan

Humanistic burden among caregivers of patients with Alzheimer's disease or dementia in Japan: a large-scale cross-sectional survey

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