Eudralex Volume 10 Annex VII TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials

Eudralex Volume 10 Annex VII TO GUIDANCE FOR THE CONDUCT OF GOOD CLINICAL PRACTICE INSPECTIONS: Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials

Annex VII

Guidance

This annex compiles specific items that may be verified during the inspection bioanalytical part and of the pharmacokinetic and statistical bioequivalence trials. The selection of items to be inspected will depend scope of the inspection and should be detailed in the inspection plan.