Sequential Bioequivalence Approaches for Parallel Designs

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 1 Mar 2013.

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 1 Mar 2013.

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 1 Mar 2013.

4. Potvin D, DiLiberti CE, Hauck WW, Parr AF, Schuirmann DJ, Smith RA. Sequential design approaches for bioequivalence studies with crossover designs. Pharm Stat. 2008;7:245–62.

5. Montague TH, Potvin D, Diliberti CE, Hauck WW, Parr AF, Schuirmann DJ. Additional results for ‘sequential design approaches for bioequivalence studies with crossover designs’. Pharm Stat. 2012;11:8–13.

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