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Guidelines for Statisticians in the Pharmaceutical Industry

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Pharmaceutical Industry GUSTAPH Statisticians Guidelines Drug Interaction Drug Administration Health Canada Medical Devices data Statistical issues Clinical Trials guidance Note bioequivalence investigation consider Points Selected guidelines 13

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Interne Links

Anchor	URL

Externe Links

Anchor	URL
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use	http://www.ich.org
Statistical principles for clinical trials (ICH E9)	http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_...
Choice of control group and related issues in clinical trials (ICH E10)	http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E10/Step4/E1...
Food and Drug Administration	http://www.fda.gov/cder/index.html
Drug Interaction Studies - Study Design, Data Analysis, and Implications for Dosing and Labeling	http://www.fda.gov/cder/guidance/6695dft.pdf
Guideline for the format and content of the clinical and statistical sections of an application	http://www.fda.gov/cder/guidance/statnda.pdf
Statistical approaches to establishing bioequivalence	http://www.fda.gov/cder/guidance/3616fnl.pdf
Health Canada	http://www.hc-sc.gc.ca/index-eng.php
Pharmaceuticals and Medical Devices Agency	http://www.pmda.go.jp/english/index.html
Basic principles on global clinical trials	http://www.pmda.go.jp/operations/notice/2007/file/0928010-e.pdf