2221-2442 2221-2442 S2221-24422022000200281 Cuba 00 12 2022 00 12 2022 53 2 281 287

1989 1992 CECMED 2014 1998 29 123-6 2006 37 1 1 75-6 International Conference of Harmonization, ICH. 2000 1992 2012 17 1 1 21-9 2017 3 2013 19 2 2 18-23 2014 12 1-2 1-2 13-8 2015 49 1 1 117-31 2010 29 1451-4 2011 65 330-5 2013 23 1 1 24-8 2016 38 1 1 8-12