Drug development of nonalcoholic fatty liver disease: challenges in research, regulatory pathways, and study endpoints
Do A, Ilagan-Ying YC, Mehal WZ, Lim JK. Drug development of nonalcoholic fatty liver disease: challenges in research, regulatory pathways, and study endpoints. Expert Opinion On Drug Discovery 2020, 16: 125-134. PMID: 33086894, DOI: 10.1080/17460441.2020.1811674.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsClinical Trials as TopicDrug ApprovalDrug DevelopmentDrug DiscoveryEndpoint DeterminationHumansNon-alcoholic Fatty Liver DiseaseObesityResearch DesignConceptsNonalcoholic fatty liver diseaseFatty liver diseaseNonalcoholic steatohepatitisLiver diseaseHealthcare resource burdenNovel trial designsClinical trial researchSignificant healthcareCase definitionClinical trialsEfficacious treatmentNew therapiesEndpoint definitionsTrial designTreatment targetsMetabolic diseasesTrial researchClinical researchDrug development processQuality data reportingDrug approvalDiseaseResource burdenRegulatory pathwaysDrug development