S7.3 - Enabling Asia-inclusive global drug development through quantitative and translational science

Drug Metabolism and Pharmacokinetics ◽

10.1016/j.dmpk.2020.04.315 ◽

2020 ◽

Vol 35 (1) ◽

pp. S13

Author(s):

Karthik Venkatakrishnan

Keyword(s):

Drug Development ◽

Translational Science ◽

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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Translational science in drug development: challenges and possible solutions

Folia Pharmacologica Japonica ◽

10.1254/fpj.148.290 ◽

2016 ◽

Vol 148 (6) ◽

pp. 290-295

Author(s):

Shyh Yuh Liou ◽

Susumu Nakade

Keyword(s):

Drug Development ◽

Translational Science

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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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Enhancing value of clinical pharmacodynamics in oncology drug development: An alliance between quantitative pharmacology and translational science

Clinical Pharmacology & Therapeutics ◽

10.1002/cpt.544 ◽

2016 ◽

Vol 101 (1) ◽

pp. 99-113 ◽

Author(s):

K Venkatakrishnan ◽

JA Ecsedy

Keyword(s):

Drug Development ◽

Translational Science ◽

Quantitative Pharmacology ◽

Oncology Drug ◽

Oncology Drug Development

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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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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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