Impact of guidance documents on translational large animal studies of cartilage repair.

ABSTRACT: Promising therapies for cartilage repair are translated through large animal models toward human application. To guide this work, regulatory agencies publish recommendations ("guidance documents") to direct pivotal large animal studies. These are meant to aid in study design, outline metrics for judging efficacy, and facilitate comparisons between studies. To determine the penetrance of these documents in the field, we synthesized the recommendations of the American Society for Testing and Materials, U.S. Food and Drug Administration, and European Medicines Agency into a scoring system and performed a systematic review of the past 20 years of preclinical cartilage repair studies. Our hypothesis was that the guidance documents would have a significant impact on how large animal cartilage re

SUBMITTER: Pfeifer CG 

PROVIDER: S-EPMC5802867 | biostudies-literature | 2015 Oct

REPOSITORIES: biostudies-literature