The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

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

Short Title:
Annex VII

European Commission

Document Type:
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.

Go back

GMP Conferences by Topics