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Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan

Clinical pharmacology and therapeutics, 2014-05, Vol.95 (5), p.533-541

2014

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Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective

Clinical pharmacology and therapeutics, 2013-08, Vol.94 (2), p.195-198

2013

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Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors

Clinical pharmacology and therapeutics, 2010-03, Vol.87 (3), p.362-366

2010

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PMDA's Challenge to Accelerate Clinical Development and Review of New Drugs in Japan

Clinical pharmacology and therapeutics, 2010-10, Vol.88 (4), p.454-457

2010

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Regulatory Science as a Bridge Between Science and Society

Clinical pharmacology and therapeutics, 2011-07, Vol.90 (1), p.29-31

2011

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How should ethnicity-related information be included on drug labels? Considerations based on comparison of multiregional clinical trial data on the label between Japan and the United States

Clinical pharmacology and therapeutics, 2015-11, Vol.98 (5), p.480-482

2015

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Representation of older patients in clinical trials for drug approval in Japan

The Journal of nutrition, health & aging, 2014-05, Vol.18 (5), p.520-523

2014

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Surface Modification and Functionalization of Polytetrafluoroethylene Films

Macromolecules, 1996-10, Vol.29 (21), p.6872-6879

1996

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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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Polymer surface with graft chains

Progress in polymer science, 2003-02, Vol.28 (2), p.209-259

2003

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Effects of cyclopiazonic acid, a novel Ca(2+)-ATPase inhibitor, on contractile responses in skinned ileal smooth muscle

British journal of pharmacology, 1992-05, Vol.106 (1), p.208-214

1992

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The utilization and challenges of Japan's MID‐NET® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

Pharmacoepidemiology and drug safety, 2019-05, Vol.28 (5), p.601-608

2019

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Increased function of voltage-dependent Ca++ channels and Ca(++)-activated K+ channels in resting state of femoral arteries from spontaneously hypertensive rats at prehypertensive stage

The Journal of pharmacology and experimental therapeutics, 1995-11, Vol.275 (2), p.775

1995

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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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Improvement of the micro-wear resistance of silicone by vacuum ultraviolet irradiation

Polymer (Guilford), 1998-06, Vol.39 (13), p.2875-2881

1998

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Cyclopiazonic acid, an inhibitor of Ca(2+)-ATPase in sarcoplasmic reticulum, increases excitability in ileal smooth muscle

British journal of pharmacology, 1993-10, Vol.110 (2), p.565-572

1993

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Size partitioning of particulate inorganic nitrogen species between the fine and coarse mode ranges and its implication to their deposition on the surface ocean

Atmospheric environment (1994), 2009-09, Vol.43 (28), p.4259-4265

2009

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Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan

Clinical pharmacology and therapeutics, 2005-08, Vol.78 (2), p.102-113

2005

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Grafting/Characterization Techniques/Kinetic Modeling

1999

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Surface lubrication of polymer films by photoinduced graft polymerization

Journal of applied polymer science, 1990-02, Vol.39 (3), p.489-498

1990

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Characteristics of Ca2+ release for activation of K+ current and contractile system in some smooth muscles

American Journal of Physiology: Cell Physiology, 1996-09, Vol.271 (3), p.C772-C782

1996

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Chemical properties and outflow patterns of anthropogenic and dust particles on Rishiri Island during the Asian Pacific Regional Aerosol Characterization Experiment (ACE-Asia)

Journal of Geophysical Research - Atmospheres, 2003-12, Vol.108 (D23), p.8666-n/a

2003

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Graft polymerization of acrylamide onto UV-irradiated films

Journal of applied polymer science, 1988-08, Vol.36 (5), p.1087-1096

1988

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ELDERLY-SPECIFIC REVISIONS OF DRUG PRESCRIBING INFORMATION IN THE POSTMARKETING ENVIRONMENT IN JAPAN

JAR life, 2016, p.1-6

2016

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Stereocontrolled Synthesis of Multi-functionalized β-Substituted α-Amino Acids: Nitrone Cycloaddition Approach

Synlett, 2000, Vol.2000 (11), p.1553-1556

2000

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Significant Differences in Drug Lag in Clinical Development Among Various Strategies Used for Regulatory Submissions in Japan

Regulatory Challenges in the Review of Data from Global Clinical Trials: The PMDA Perspective

Effective Global Drug Development Strategy for Obtaining Regulatory Approval in Japan in the Context of Ethnicity-Related Drug Response Factors

PMDA's Challenge to Accelerate Clinical Development and Review of New Drugs in Japan

Regulatory Science as a Bridge Between Science and Society

How should ethnicity-related information be included on drug labels? Considerations based on comparison of multiregional clinical trial data on the label between Japan and the United States

Representation of older patients in clinical trials for drug approval in Japan

Surface Modification and Functionalization of Polytetrafluoroethylene Films

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

Polymer surface with graft chains

Effects of cyclopiazonic acid, a novel Ca(2+)-ATPase inhibitor, on contractile responses in skinned ileal smooth muscle

The utilization and challenges of Japan's MID‐NET® medical information database network in postmarketing drug safety assessments: A summary of pilot pharmacoepidemiological studies

Increased function of voltage-dependent Ca++ channels and Ca(++)-activated K+ channels in resting state of femoral arteries from spontaneously hypertensive rats at prehypertensive stage

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

Improvement of the micro-wear resistance of silicone by vacuum ultraviolet irradiation

Cyclopiazonic acid, an inhibitor of Ca(2+)-ATPase in sarcoplasmic reticulum, increases excitability in ileal smooth muscle

Size partitioning of particulate inorganic nitrogen species between the fine and coarse mode ranges and its implication to their deposition on the surface ocean

Successful bridging strategy based on ICH E5 guideline for drugs approved in Japan

Grafting/Characterization Techniques/Kinetic Modeling

Surface lubrication of polymer films by photoinduced graft polymerization

Characteristics of Ca2+ release for activation of K+ current and contractile system in some smooth muscles

Chemical properties and outflow patterns of anthropogenic and dust particles on Rishiri Island during the Asian Pacific Regional Aerosol Characterization Experiment (ACE-Asia)

Graft polymerization of acrylamide onto UV-irradiated films

ELDERLY-SPECIFIC REVISIONS OF DRUG PRESCRIBING INFORMATION IN THE POSTMARKETING ENVIRONMENT IN JAPAN

Stereocontrolled Synthesis of Multi-functionalized β-Substituted α-Amino Acids: Nitrone Cycloaddition Approach

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