Pilot and Repeat Trials as Development Tools Associated with Demonstration of Bioequivalence

Author:

Fuglsang Anders

Publisher

Springer Science and Business Media LLC

Subject

Pharmaceutical Science

Reference9 articles.

1. Committee for Human Medicinal Products. Investigation of bioequivalence. CHMP CPMP/EWP/QWP/1401/98 Rev. 1. 2010. http://www.ema.europa.eu/ema/pages/includes/document/open_document.jsp?webContentId=WC500070039 . Accessed 10 Aug 2014.

2. United States Food and Drug Administration, Center for Drug Evaluation and Research. Statistical Approaches to Establishing Bioequivalence. Guidance for Industry: Statistical Approaches to Establishing Bioequivalence. 2001. http://www.fda.gov/downloads/Drugs/Guidances/ucm070244.pdf . Accessed 10 Aug 2014.

3. Therapeutic Products Directorate, Health Canada. Conduct and Analysis of Comparative Bioavailability Studies. 2012. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd_cbs_ebc_ld-eng.pdf . Accessed 10 Aug 2014.

4. World Medical Association. Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. 2013. http://www.wma.net/en/30publications/10policies/b3/ . Accessed 10 Aug 2014.

5. Steering Committee (International Conference of Harmonization). Statistical Principles for Clinical Trials. International Conference of Harmonization. 1998. Available via http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E9/Step4/E9_Guideline.pdf .

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