ICH Guidelines for Biostatisticians in Industry ... Application with 1.) Meta-analyses and 2.) One Pivotal study (adopted by CPMP May 2001) CPMP/EWP/QWP/1401/98 Note For Guidance on the Investigation of Bioavailability and Bioequivalence (Adopted July 2001) CHMP/EWP/2459/02 Reflection Paper on ...