On the interchangeability of biologic drug products

Author:

Endrenyi Laszlo1,Chang Chiann2,Chow Shein-Chung3,Tothfalusi Laszlo4

Affiliation:

1. University of Toronto; Toronto; Canada

2. Universidade de São Paulo; São Paulo; Brazil

3. Duke University School of Medicine; Durham; NC; U.S.A.

4. Semmelweis University; Budapest; Hungary

Publisher

Wiley

Subject

Statistics and Probability,Epidemiology

Reference31 articles.

1. FDA Guidance on bioavailability and bioequivalence studies for orally administrated drug products - general considerations Center for Drug Evaluation and Research, US Food and Drug Administration Rockville, MD 2003 http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070124.pdf

2. Health Canada Guidance document: conduct and analysis of comparative bioavailability studies Health Canada Ottawa, ON 2002 http://www.hc-sc.gc.ca/dhp-mps/alt\_formats/pdf/prodpharma/applic-demande/guide-ld/bio/gd\_cbs\_ebc\_ld-eng.pdf

3. European Medicines Agency (EMA) Guideline on the investigation of bioequivalence Committee for Medicinal Products for Human Use London 2010 http://www.ema.europa.eu/docs/en\_GB/document\_library/Scientific\_guideline/2010/01/WC500070039.pdf

4. Quantitative evaluation of bioequivalence/biosimilarity;Chow;Journal of Bioequivalence and Bioavailability,2011

5. Biosimilars: an overview;Sekhon;Biosimilars,2011

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