2340-9894 2340-9894 S2340-98942018000100004 10.30827/ars.v59i1.7277 Costa Rica Costa Rica 00 03 2018 00 03 2018 59 1 27 35

1 2012 10 4 4 233-8 2 European Medicines Agency 2013 3 2015 21 11 11 1859-60 4 2010 87 3 3 257-61 5 2011 117 1 1 c1-7 6 2016 45 S1-S10 7 2012 59 8 2016 36 613-25 9 2016 46 73-9 10 2001 103 24 24 2994-3018 11 2016 97 237-49 12 2014 44 5 5 497-500 13 2015 11 5 5 269-78 14 2000 42 15 2014 3 3 3 143-8 16 Consejo Internacional de Armonización de los requisitos técnicos para el registro de medicamentos de uso humano 2003 17 Committee for Medicinal Products for Human Use 2014 18 Health Canada 2016 19 European Medicines Agency 2008 20 2010 20 1 1 46-61 21 World Health Organization 2009 22 Committee for Medicinal Products for Human Use 2014 23 US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research 2015 24 Generics and Biosimilars Initiative 25 2015 115 431-42 26 2011 127 Suplemento 3 Suplemento 3 S100-4 27 2012 98 1 1 e11-4 28 2012 31 2 2 101-4 29 2013 18 5-6 5-6 305-11