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1-10 of 6361 results for Clinical safety data

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Select article: Japanese Perspectives on Harmonization Initiatives: Problems in Assessing Predrug Approval Clinical Safety Data

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First published 1994-4

Japanese Perspectives on Harmonization Initiatives: Problems in Assessing Predrug Approval Clinical Safety Data

Chikayuki Naito

Therapeutic Innovation & Regulatory Science

Select article: Clinical Safety,Administration and Data Systems: How Should They be Integrated?

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First published 1995-4

Clinical Safety,Administration and Data Systems: How Should They be Integrated?

Steve Jolley

Therapeutic Innovation & Regulatory Science

Select article: A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

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Research article

First published 2016-11

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Patrick M. Schnell, Greg Ball

Therapeutic Innovation & Regulatory Science

Select article: Hepatotoxicity in the Review of Clinical Safety Data

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First published 2003-4

Hepatotoxicity in the Review of Clinical Safety Data

Yeong-Liang Lin, Herng-Der Chern, Mong-Ling Chu

Therapeutic Innovation & Regulatory Science

Select article: Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained

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First published 2000-1

Evaluation of Safety Data from Controlled Clinical Trials: The Clinical Principles Explained

John E. Gait, Sandy Smith, Sherri L. Brown

Therapeutic Innovation & Regulatory Science

Select article: Analysis of Drug Safety Data from Clinical Trials

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First published 2002-1

Analysis of Drug Safety Data from Clinical Trials

Andrzej Czarnecki, Katarzyna Zalewska

Therapeutic Innovation & Regulatory Science

Select article: Interpreting Clinical Laboratory Data in Safety Assessment Studies

Free access

Research article

First published 1992-5

Interpreting Clinical Laboratory Data in Safety Assessment Studies

Michael C. Carakostas

Toxicologic Pathology

Select article: Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees

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Research article

First published 2006-6

Guidelines for data and safety monitoring for clinical trials not requiring traditional data monitoring committees

SCT Working Group on Data Monitoring, Dennis O Dixon, Ralph S Freedman [...]

Clinical Trials

Select article: Institutionally Chartered Data and Safety Monitoring Boards: Structured Approaches to Assuring Participant Safety in Clinical Research

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Research article

First published 2021-6

Institutionally Chartered Data and Safety Monitoring Boards: Structured Approaches to Assuring Participant Safety in Clinical Research

Blair Holbein, Marie T Rape, Barbara N Hammack [...]

Journal of Investigative Medicine

Select article: Use of the false discovery rate for evaluating clinical safety data

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Research article

First published 2004-06

Use of the false discovery rate for evaluating clinical safety data

Devan V Mehrotra, Joseph F Heyse

Statistical Methods in Medical Research

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