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1-10 of 171 results for ICH guidelines

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Select article: The ICH Guideline for Stability Testing—What Matrixing does it Permit?

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First published 1998-4

The ICH Guideline for Stability Testing—What Matrixing does it Permit?

David J. Pack

Therapeutic Innovation & Regulatory Science

Select article: An Algorithmic Approach to Incorporating the ICH E2A Guidelines into Safety Department ADR Reporting in the United States

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First published 1999-7

An Algorithmic Approach to Incorporating the ICH E2A Guidelines into Safety Department ADR Reporting in the United States

Stephen L. Klincewicz, Nancy A. Woolpert, Mark K. Blake [...]

Therapeutic Innovation & Regulatory Science

Select article: Overview of the ICH GCP Guideline

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First published 1997-10

Overview of the ICH GCP Guideline

Keiji Ueda

Therapeutic Innovation & Regulatory Science

Select article: Impact of the ICH E9 Guideline Statistical Principles for Clinical Trials on the Conduct of Clinical Trials in Japan

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First published 2003-10

Impact of the ICH E9 Guideline Statistical Principles for Clinical Trials on the Conduct of Clinical Trials in Japan

Chihiro Hirotsu, Ludwig A. Hothorn

Therapeutic Innovation & Regulatory Science

Select article: Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

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Brief report

First published 2019

Defining Efficacy Estimands in Clinical Trials: Examples Illustrating ICH E9(R1) Guidelines

Bohdana Ratitch, Niti Goel, Craig Mallinckrodt [...]

Therapeutic Innovation & Regulatory Science

Select article: International Conference on Harmonization-Keeping International Drug Development in Harmony?

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First published 2001-4

International Conference on Harmonization-Keeping International Drug Development in Harmony?

Craig McCarthy

Therapeutic Innovation & Regulatory Science

Select article: Impact of the ICH Guideline on Ethnic Differences

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First published 1998-1

Impact of the ICH Guideline on Ethnic Differences

Helene Dumitriu

Therapeutic Innovation & Regulatory Science

Select article: Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences

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First published 2009-1

Bridging Studies in Japan and Taiwan: A Dynamic Evolution in Regulating Ethnic Differences

Wen-Hua Kuo

Therapeutic Innovation & Regulatory Science

Select article: ICH: Strengths,Weaknesses,and Future Tasks

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Research article

First published 2014-5

ICH: Strengths,Weaknesses,and Future Tasks

Sebastian Specht, Ingrid Klingmann

Therapeutic Innovation & Regulatory Science

Select article: Statistical/Practical Issues in Clinical Trials

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First published 1997-10

Statistical/Practical Issues in Clinical Trials

Annpey Pong, Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

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