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1-10 of 117 results for Common Technical Document

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Select article: The Electronic Common Technical Document (eCTD)

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Research article

First published 2012-1

The Electronic Common Technical Document (eCTD)

Andreas Suchanek, Herwig Ostermann

Therapeutic Innovation & Regulatory Science

Select article: Electronic common technical document submission with analysis using R

Open access

Research article

First published 2023-2

Electronic common technical document submission with analysis using R

Yujie Zhao, Nan Xiao, Keaven Anderson [...]

Clinical Trials

Select article: Electronic Common Technical Document Implementation in Japan

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Other

First published 2009-7

Electronic Common Technical Document Implementation in Japan

Kiyohito Nakai, Yasuhiro Araki, Daigoro Ebina [...]

Therapeutic Innovation & Regulatory Science

Select article: ICH M4/The Common Technical Document (CTD): Comparison of Clinical Documents and Summaries Assessment Practices in the United States,Europe,and Japan *

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Other

First published 1999-4

ICH M4/The Common Technical Document (CTD): Comparison of Clinical Documents and Summaries Assessment Practices in the United States,Europe,and Japan *

Françoise de Crémiers

Therapeutic Innovation & Regulatory Science

Select article: Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations

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Other

First published 2008-3

Preparing the Common Technical Document for Registration of Pharmaceuticals for Human Use (CTD)—Insights and Recommendations

Robert I. Roth

Therapeutic Innovation & Regulatory Science

Select article: The Common Technical Document as academic guideline

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Editorial

First published 2015-1

The Common Technical Document as academic guideline

Pharmaceuticals Policy and Law

Select article: How Should a Globalized CTD Be Created? An Introduction to the Japanese 3-Layer Approach

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Research article

First published 2015-1

How Should a Globalized CTD Be Created? An Introduction to the Japanese 3-Layer Approach

Katsumi Yoshida, Naoto Awaji, Kazumasa Takenouchi [...]

Therapeutic Innovation & Regulatory Science

Select article: An Overview of the Drug Registration Requirements for Export to Tanzania,Nepal,and Cambodia

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Review article

First published 2019

An Overview of the Drug Registration Requirements for Export to Tanzania,Nepal,and Cambodia

Triveni V. Shelke, Shyam Khante, Mukund B. Sarda [...]

Therapeutic Innovation & Regulatory Science

Select article: The common technical document as basis of the authorization of marketing of medicinal products in the European Union

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Research article

First published 2015-1

The common technical document as basis of the authorization of marketing of medicinal products in the European Union

María Dolores Cabezas

Pharmaceuticals Policy and Law

Select article: Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

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Other

First published 2009-08

Guidance for Industry: Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document

Biotechnology Law Report

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