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Articles (153)

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1-10 of 153 results for Integrated safety summaries

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Select article: Preparing an Integrated Summary of Safety: A Writer's Perspective

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Other

First published 1998-1

Preparing an Integrated Summary of Safety: A Writer's Perspective

Sharie Myers, Beth Baron, Lyn Radke-Mitchell [...]

Therapeutic Innovation & Regulatory Science

Select article: Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)

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First published 2010-9

Understanding the Differences and Effectively Transitioning between the US Integrated Summaries of Effectiveness and Safety (ISE/ISS) and the CTD Summaries of Clinical Efficacy and Safety (SCE/SCS)

David N. Schwartz, Michael J. Umen, Kathy Nomides [...]

Therapeutic Innovation & Regulatory Science

Select article: Can There Really Be an Integrated Safety Summary?

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Research article

First published 1991-10

Can There Really Be an Integrated Safety Summary?

Thomas Q. Garvey

Therapeutic Innovation & Regulatory Science

Select article: The Regulatory Evolution of the Integrated Safety Summary

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Research article

First published 1991-10

The Regulatory Evolution of the Integrated Safety Summary

Robert J. Temple

Therapeutic Innovation & Regulatory Science

Select article: Approaches to Describing Common Adverse Events in the Integrated Safety Summary

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Research article

First published 1991-10

Approaches to Describing Common Adverse Events in the Integrated Safety Summary

Charles Lineberry

Therapeutic Innovation & Regulatory Science

Select article: Preface: Preparation of an Integrated Safety Summary for a New Drug Application

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Research article

First published 1991-10

Preface: Preparation of an Integrated Safety Summary for a New Drug Application

David M. Cocchetto, Cheryl F. Graham

Therapeutic Innovation & Regulatory Science

Select article: Current Reporting Methods for Laboratory Data at Zeneca Pharmaceuticals

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Other

First published 1994-4

Current Reporting Methods for Laboratory Data at Zeneca Pharmaceuticals

Jill M. Davis

Therapeutic Innovation & Regulatory Science

Select article: Pooling in Integrated Safety Databases

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Other

First published 2000-4

Pooling in Integrated Safety Databases

Damian J. McEntegart

Therapeutic Innovation & Regulatory Science

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

Select article: The effects of inhaled corticosteroids on the endocrine system

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Research article

First published 1994-3

The effects of inhaled corticosteroids on the endocrine system

P.I. Folb

International Journal of Risk & Safety in Medicine

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