Bioequivalence

Bioavailability/Bioequivalence, GCP/GLP, dissolution/BCS, pharmacokinetics, bioanalytics and -statistics

Main topic of this collection is Bioavailability / (in-vivo-) Bioequivalence, although GCP/GLP, dissolution/BCS, pharmacokinetics, bioanalytics and -statistics are also covered to some minor extent.   International Conference on Harmonisation Guidelines Development Safety Update Report; E2F: step 4, Aug 2010 (PDF334KB) Structure and Content of Clinical Study Reports; E3: Nov 1995 (PDF471KB) Good Clinical Practice; E6(R1): step 4, Jun 1996 (PDF380KB; including IBtemplate) […]