AddStat: Statistical Links

internal websites Guidelines Guidelines Bioequivalence Portals, Textbooks, Websites Statistical software Please select!

... add statistics to your data:   use ressources from internet

At this page, some useful links are provided.
AddStat is not liable for content of external pages.

Internal websites

• Download
• Web-Shop

Guidelines

• EMEA: ICH topic E 6: Guideline for good clinical practice
• EMEA: ICH topic E 9: Statistical principles in Clinical Trials:
• EMEA: ICH topic E 3: Guidance on Structure and Content of Clinical Study Reports:

Guidelines - diagnostic medicine

• STARD: STAndards for the Reporting of Diagnostic accuracy studies
• FDA: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests
• FDA: Guidance for Industry: Regulating In Vitro Diagnostic Device (IVD) Studies
• FDA: Guidance for Industry: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

Web sources - diagnostic medicine

• MS Pepe's website: The Diagnostic and Biomarkers Statistical (DABS) Center
• MS Pepe's book: Examples, presentations etc. related to book Pepe MS: The Statistical Evalutaion of Medical Tests for Classification and Prediction. Oxford University Press 2003, New York

Guidelines - Bioeqivalence

• EMEA: Note for guidance on the Investigation of Bioavailability and Bioequivalence
• FDA: Guidance for Industry: Statistical approaches to establishing Bioequivalence

Portals, Textbooks, Websites

• Tools, Technology and Training for Healthcare Labs: www.westgard.com
• Zanen: Bioequivalence and Generic Medicines

Statistical software* used by AddStat

• SAS®: statistical package
• SPSS®: statistical package
• Medcalc®: statistical package for clinical lab and evaluation of diagnostic tests
• BiAS. für Windows^TM: a low budget, but very goots statistical package (german language)
• R: open source software for statistical computing
• NCSS, PASS: statistical package, sample size estimation
• Analyse-It®: statistical software add-in for MS Excel
• nQuery Advisor®: sample size estimation
• EquivTest^TM: Equivalence tests

*Remark: Most of these names are trademarks. Therefore, links to these external software don't implicate free availability of the packages. The links are presented only for information.