Clinical evaluation of medicinal products intended for treatment of hepatitis B

Current effective version

PDF iconAdopted guideline

Reference numberCPMP/EWP/6172/2003
Published23/02/2006
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.



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