{"id":"W4412594961","doi":"10.1093/ecco-jcc/jjaf111","title":"Comparison of the FDA and EMA guidance on drug development in ulcerative colitis: an expert panel review","year":2025,"lang":"en","type":"review","venue":"Journal of Crohn s and Colitis","topic":"Inflammatory Bowel Disease","field":"Biochemistry, Genetics and Molecular Biology","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"McMaster University; Western University; University of Calgary","funders":"","keywords":"Medicine; Ulcerative colitis; Drug; Drug development; Tofacitinib; Internal medicine; Intensive care medicine; Pharmacology; Disease","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.1343399,0.001403848,0.003637494,0.01202936,0.001483507,0.005225653,0.00542159,0.006532645,0.003635251],"category_scores_gemma":[0.1503349,0.001017761,0.005570231,0.01025989,0.001590128,0.004124125,0.003128206,0.004863276,0.001379917],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00789895,"about_ca_system_score_gemma":0.03206225,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00763764,"about_ca_topic_score_gemma":0.01346476,"domain_scores_codex":[0.9289514,0.03205727,0.01465375,0.00277797,0.0200722,0.0014874],"domain_scores_gemma":[0.8094633,0.1037408,0.01683338,0.003050022,0.06384828,0.003064204],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0005170477,0.0001402741,0.001774108,0.08745511,0.00191942,0.0003452083,0.001042336,0.001174531,0.0009527326,0.008946856,0.1884715,0.7072608],"study_design_scores_gemma":[0.0003295165,0.0002757535,0.004581939,0.2485155,0.004551237,0.000414449,0.0005727432,0.0004349576,0.001046626,0.00318292,0.7359664,0.0001280429],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.001211116,0.9411067,0.003304266,0.03818202,0.002801819,0.001315923,0.0009623035,0.00005267924,0.01106321],"genre_scores_gemma":[0.02175607,0.9173814,0.01718883,0.03577834,0.001979225,0.002115235,0.001638433,0.00008848633,0.002074028],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.1343399,"threshold_uncertainty_score":0.7104656,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0320659033394963,"score_gpt":0.345660803392896,"score_spread":0.3135949000533996,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}