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Articles (49)

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1-10 of 49 results for Statistical regulatory guidelines

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Select article: The International Conference on Harmonization Guideline “Statistical Principles for Clinical Trials”: Issues in Applying the Guideline in Practice

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First published 2000-4

The International Conference on Harmonization Guideline “Statistical Principles for Clinical Trials”: Issues in Applying the Guideline in Practice

Alan Phillips, Alan Ebbutt, Lesley France [...]

Therapeutic Innovation & Regulatory Science

Select article: Recent Methodological Issues in Drug Evaluation: A Perspective from the United States *

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Research article

First published 1995-10

Recent Methodological Issues in Drug Evaluation: A Perspective from the United States *

Robert T. O'Neill

Therapeutic Innovation & Regulatory Science

Select article: Ensuring Good Statistical Practice in Clinical Research: Guidelines for Standard Operating Procedures (An Update)

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First published 1998-7

Ensuring Good Statistical Practice in Clinical Research: Guidelines for Standard Operating Procedures (An Update)

Philip M. North

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

Select article: Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) Working Group

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First published 1999-4

Qualified Statisticians in the European Pharmaceutical Industry: Report of a European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) Working Group

David Morgan

Therapeutic Innovation & Regulatory Science

Select article: Two-stage Testing of Safety: A Statistical View

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Research article

First published 2003-11

Two-stage Testing of Safety: A Statistical View

Dieter Hauschke, Ludwig A. Hothorn

Alternatives to Laboratory Animals

Select article: Multicentre trials: a US regulatory perspective

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Research article

First published 2005-06

Multicentre trials: a US regulatory perspective

Charles Anello, Robert T O’Neill, Satya Dubey

Statistical Methods in Medical Research

Select article: Recommendations to Improve End-of-Life Care Through Regulatory Change in U.S. Health Care Financing

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Research article

First published 2002-02

Recommendations to Improve End-of-Life Care Through Regulatory Change in U.S. Health Care Financing

Charles F. von Gunten, Frank D. Ferris, Robert D'Antuono [...]

Journal of Palliative Medicine

Select article: Statistics and Statisticians in European Drug Regulatory Agencies

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First published 1998-1

Statistics and Statisticians in European Drug Regulatory Agencies

Wolfgang Köpcke, David R. Jones, Bernhard Huitfeldt [...]

Therapeutic Innovation & Regulatory Science

Select article: Opportunities for Reduction in Acute Toxicity Testing via Improved Design

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Research article

First published 2004-9

Opportunities for Reduction in Acute Toxicity Testing via Improved Design

Anne Whitehead, Nigel Stallard

Alternatives to Laboratory Animals

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