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) […]

Clopidogrel bioequivalence study.Sample.

QUOTATION CLOPIDOGREL 75 Tablets   Study design: a two-period, crossover, single-dose bioequivalence study in 36 healthy volunteers of both sexes, clinical confinement during 10 hours before and 32 hours after the dose, 20 blood samples per subject per period will be collected before dosing and till 32 hours after the drug administration, at least 7 […]