Clinical investigation of medicinal products for the treatment of ankylosing spondylitis
This document provides guidance for the clinical evaluation of new medicinal products for the treatment of ankylosing spondylitis. It addresses the patient characteristics and selection criteria, as well as efficacy assessement. It outlines strategies for early studies in man (dose-response trials) as well as for therapeutic confirmatory trials and specific aspects of evaluation of clinical safety.
Click on this link for more information.
