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Orphan drug designation and development in Japan: 25 years of experience and assessment

Nature reviews. Drug discovery, 2021-12, Vol.20 (12), p.893-894

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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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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Aggravation by selective COX-1 and COX-2 inhibitors of dextran sulfate sodium (DSS)-induced colon lesions in rats

Digestive diseases and sciences, 2007-09, Vol.52 (9), p.2095-2103

2007

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Gastro-protective action of lafutidine mediated by capsaicin-sensitive afferent neurons without interaction with TRPV1 and involvement of endogenous prostaglandins

World journal of gastroenterology : WJG, 2006-05, Vol.12 (19), p.3031

2006

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Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline

Clinical pharmacology and therapeutics, 2024-05, Vol.115 (5), p.965-970

2024

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Healing Impairment Effect of Cyclooxygenase Inhibitors on Dextran Sulfate Sodium-Induced Colitis in Rats

Digestion, 2006-01, Vol.74 (2), p.91-100

2006

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Improved development of mouse and human embryos using a tilting embryo culture system

Reproductive biomedicine online, 2010-03, Vol.20 (3), p.358-364

2010

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The involvement of DNA and histone methylation in the repression of IL-1β-induced MCP-1 production by hypoxia

Biochemical and biophysical research communications, 2011-10, Vol.414 (1), p.252-258

2011

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Index of application status transparency and availability of public information for Project Orbis agencies

International Journal of Drug Regulatory Affairs, 2024-09, Vol.12 (3), p.55-65

2024

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Increased susceptibility of small intestine to NSAID-provoked ulceration in rats with adjuvant-induced arthritis: Involvement of enhanced expression of TLR4

Life sciences (1973), 2007-09, Vol.81 (16), p.1309-1316

2007

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A new screw fixation technique via an intraoral approach and its stability in sagittal splitting ramus osteotomy

Nihon Koku Geka Gakkai zasshi, 2007, Vol.53 (3), p.197-200

2007

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General Introduction of E17

Simultaneous Global New Drug Development, 2022, p.1-9

1, 2022

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Implementation of the ICH E17 Guideline in Japan

Simultaneous Global New Drug Development, 2022, p.87-94

1, 2022

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The Debate on Single Embryo Transfer in IVF/ICSI —What Should the Indications for eSET Be

Journal of mammalian ova research, 2008-04, Vol.25 (2), p.74-81

2008

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The Debate on Single Embryo Transfer in IVF/ICSI —What Should the Indications for eSET Be

Journal of Mammalian Ova Research, 2008, Vol.25 (2), p.74-81

2008

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Examination of mandibular ramus thickness by dental conebeam computed tomography in patients with jaw deformity

Nihon Koku Geka Gakkai zasshi, 2006, Vol.52 (10), p.574-577

2006

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Histological and quantitative image analyses of rice gall formed by orange leafhopper Cicadulina bipunctata (Hemiptera: Cicadellidae)

Applied entomology and zoology, 2021-08, Vol.56 (3), p.419-425

2021

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Significance of Basal Membrane Permeability of Epithelial Cells in Predicting Intestinal Drug Absorption

Drug metabolism and disposition, 2023-03, Vol.51 (3), p.318-328

2023

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Safety and efficacy of osimertinib rechallenge or continuation after pneumonitis: A multicentre retrospective cohort study

European journal of cancer (1990), 2023-01, Vol.179, p.15-24

2023

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Multiple Skin Abscesses Caused by Rhizopus sp. Infection after Candida albicans Infection in an Immunocompromised Patient

Medical Mycology Journal, 2019, Vol.60(1), pp.17-21

2019

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Drug-Related Pneumonitis Induced by Osimertinib as First-Line Treatment for Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer

Chest, 2022-11, Vol.162 (5), p.1188-1198

2022

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Nanaomycin H: A new nanaomycin analog

Journal of bioscience and bioengineering, 2017-06, Vol.123 (6), p.765-770

2017

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Dual Effect of Organogermanium Compound THGP on RIG-I-Mediated Viral Sensing and Viral Replication during Influenza a Virus Infection

Viruses, 2021-08, Vol.13 (9), p.1674

2021

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Orphan drug designation and development in Japan: 25 years of experience and assessment

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

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

Aggravation by selective COX-1 and COX-2 inhibitors of dextran sulfate sodium (DSS)-induced colon lesions in rats

Gastro-protective action of lafutidine mediated by capsaicin-sensitive afferent neurons without interaction with TRPV1 and involvement of endogenous prostaglandins

Summary Report of a Public Workshop: Case Studies of Multi‐Regional Clinical Trial Incorporating Concept of the ICH E17 Guideline

Healing Impairment Effect of Cyclooxygenase Inhibitors on Dextran Sulfate Sodium-Induced Colitis in Rats

Improved development of mouse and human embryos using a tilting embryo culture system

The involvement of DNA and histone methylation in the repression of IL-1β-induced MCP-1 production by hypoxia

Index of application status transparency and availability of public information for Project Orbis agencies

Increased susceptibility of small intestine to NSAID-provoked ulceration in rats with adjuvant-induced arthritis: Involvement of enhanced expression of TLR4

A new screw fixation technique via an intraoral approach and its stability in sagittal splitting ramus osteotomy

General Introduction of E17

Implementation of the ICH E17 Guideline in Japan

The Debate on Single Embryo Transfer in IVF/ICSI —What Should the Indications for eSET Be

The Debate on Single Embryo Transfer in IVF/ICSI —What Should the Indications for eSET Be

Examination of mandibular ramus thickness by dental conebeam computed tomography in patients with jaw deformity

Histological and quantitative image analyses of rice gall formed by orange leafhopper Cicadulina bipunctata (Hemiptera: Cicadellidae)

Significance of Basal Membrane Permeability of Epithelial Cells in Predicting Intestinal Drug Absorption

Safety and efficacy of osimertinib rechallenge or continuation after pneumonitis: A multicentre retrospective cohort study

Multiple Skin Abscesses Caused by Rhizopus sp. Infection after Candida albicans Infection in an Immunocompromised Patient

Drug-Related Pneumonitis Induced by Osimertinib as First-Line Treatment for Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer

Nanaomycin H: A new nanaomycin analog

Drug-Related Pneumonitis Induced by Osimertinib as First-Line Treatment for Epidermal Growth Factor Receptor Mutation-Positive Non-Small Cell Lung Cancer: A Real-World Setting

Dual Effect of Organogermanium Compound THGP on RIG-I-Mediated Viral Sensing and Viral Replication during Influenza a Virus Infection

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