Clinical evaluation of medicinal products intended for treatment of hepatitis B

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/EWP/6172/2003
Effective from01/09/2006
KeywordsHepatitis B, diagnostic criteria, non-inferiority trials, superiority trials, endpoints, comparator, special populations, safety evaluation
DescriptionThis document provides guidance on the clinical evaluation of new medicinal products in the treatment of chronic hepatitis B.

Related content

How useful was this page?

Add your rating