Biodisponibilité/Bioéquivalence, BPC/BPL, dissolution/BCS, pharmacocinétique, bioanalyse et statistiques

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) Bonnes pratiques cliniques; E6(R1): step 4, Jun 1996 (PDF380KB; including IBtemplate) General Considerations for Clinical Trials; E8: Jul 1997 (PDF182KB) Clinical Safety Data Management: Definitions and Standards for Expedited Reporting; E2A: step Lire la suite