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1-4 of 4 results for United States and Japanese submission

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Select article: Preclinical Considerations for Regulatory Submissions

Retricted access

Other

First published 2001-1

Preclinical Considerations for Regulatory Submissions

Paul Baldrick

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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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: The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

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First published 2005-7

The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

Shunsuke Ono, Chisato Yoshioka, Orie Asaka [...]

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Forum Opinion Piece*

Free access

Research article

First published 2014-8

Regulatory Forum Opinion Piece*

Yoichi Konishi, Shim-mo Hayashi, Shoji Fukushima

Toxicologic Pathology

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