Global Drug Development Based on ICH-E5 Guideline.

Drug Metabolism and Pharmacokinetics ◽

10.2133/dmpk.15.381 ◽

2000 ◽

Vol 15 (4) ◽

pp. 381-385

Author(s):

Hidefumi MATSUI

Keyword(s):

Drug Development ◽

Global Drug Development

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Design and Sample Size Considerations for Simultaneous Global Drug Development Program

Journal of Biopharmaceutical Statistics ◽

10.1080/10543406.2012.701587 ◽

2012 ◽

Vol 22 (5) ◽

pp. 1060-1073 ◽

Author(s):

Qin Huang ◽

Gang Chen ◽

Zhilong Yuan ◽

K. K. Gordon Lan

Keyword(s):

Drug Development ◽

Sample Size ◽

Development Program ◽

Drug Development Program ◽

Global Drug Development

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Guest Editor's Note: A European Concept for Good Statistical Practices in Global Drug Development

Drug Information Journal ◽

10.1177/009286159502900215 ◽

1995 ◽

Vol 29 (2) ◽

pp. 471-471 ◽

Author(s):

Andreas Zipfel

Keyword(s):

Drug Development ◽

Global Drug Development

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Application of Pharmacokinetics and Pharmacodynamics in Antimicrobial Global Drug Development

Antimicrobial Pharmacodynamics in Theory and Clinical Practice ◽

10.3109/9781420017137-24 ◽

2007 ◽

pp. 445-460

Keyword(s):

Drug Development ◽

Pharmacokinetics And Pharmacodynamics ◽

Global Drug Development

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Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2008.144 ◽

2008 ◽

Vol 84 (3) ◽

pp. 287-294 ◽

Author(s):

S-M Huang ◽

R Temple

Keyword(s):

Clinical Practice ◽

Drug Development ◽

Regulatory Review ◽

Ethnic Factors ◽

Global Drug Development

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Cultural differences: implications on drug therapy and global drug development

International Journal of Clinical Pharmacology and Therapeutics ◽

10.5414/cpp38047 ◽

2000 ◽

Vol 38 (02) ◽

pp. 47-52 ◽

Author(s):

L.P. Balant ◽

E.A. Balant-Gorgia

Keyword(s):

Drug Therapy ◽

Drug Development ◽

Cultural Differences ◽

Global Drug Development

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Impact of Global Drug Development on Industry—Mergers, Acquisitions, and Joint Ventures

Drug Information Journal ◽

10.1177/009286159302700423 ◽

1993 ◽

Vol 27 (4) ◽

pp. 1089-1093

Author(s):

Brian Tambi

Keyword(s):

Drug Development ◽

Joint Ventures ◽

Global Drug Development

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Approaches to Japanese Dose Evaluation in Global Drug Development: Factors That Generate Different Dosages Between Japan and the United States

Clinical Pharmacology & Therapeutics ◽

10.1038/clpt.2011.156 ◽

2011 ◽

Vol 90 (6) ◽

pp. 836-843 ◽

Author(s):

K Nakashima ◽

M Narukawa ◽

M Takeuchi

Keyword(s):

United States ◽

Drug Development ◽

The United States ◽

Dose Evaluation ◽

Global Drug Development

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Application of Pharmacokinetics and Pharmacodynamics in Antimicrobial Global Drug Development

Infectious Disease and Therapy - Antimicrobial Pharmacodynamics in Theory and Clinical Practice ◽

10.3109/9781420017137.021 ◽

2007 ◽

pp. 433-448

Author(s):

Sujata M. Bhavnani

Keyword(s):

Drug Development ◽

Pharmacokinetics And Pharmacodynamics ◽

Global Drug Development

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Using Technology to Support Global Drug-Development Teams

Exploring the Rhetoric of International Professional Communication ◽

10.4324/9781315224626-5 ◽

2020 ◽

pp. 55-79

Author(s):

Stephen A. Bernhardt

Keyword(s):

Drug Development ◽

Development Teams ◽

Global Drug Development

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Leveraging Foreign Clinical Data Extrapolation to Accelerate Global Drug Development: A Case Study in Hematological Oncology

10.1201/9781003109785-10 ◽

2021 ◽

pp. 129-135

Author(s):

Hongjie Zhu ◽

Jingjing Ye ◽

Xiang Guo

Keyword(s):

Drug Development ◽

Clinical Data ◽

Data Extrapolation ◽

Global Drug Development

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