{"id":"W4392984296","doi":"10.1097/hep.0000000000000864","title":"Primary biliary cholangitis drug evaluation and regulatory approval: Where do we go from here?","year":2024,"lang":"en","type":"article","venue":"Hepatology","topic":"Liver Diseases and Immunity","field":"Medicine","cited_by":33,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Calgary; Toronto General Hospital; University of Toronto; University Health Network","funders":"Genentech; Eisai; Novo Nordisk; CSL Behring; National Institute for Health and Care Research; European Association for the Study of the Liver; Pfizer; Moderna; ZonMw; Audentes Therapeutics; LifeArc; Regeneron Pharmaceuticals; Bristol-Myers Squibb; AstraZeneca; Ipsen; Alnylam Pharmaceuticals; Ultragenyx Pharmaceutical; Amsterdam University Medical Centers; EA Pharma Co., Ltd.; Gilead Sciences; American Association for the Study of Liver Diseases; Kowa Company; Sanofi; GlaxoSmithKline","keywords":"Drug; Medicine; Internal medicine; Drug approval; Pharmacology; Gastroenterology","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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0002459527,0.0001268585,0.0002539816,0.00008056109,0.00005442094,0.00002962447,0.00005820028,0.0001201581,0.0007739413],"category_scores_gemma":[0.00002866301,0.0001082422,0.00007521154,0.0001041911,0.0001122724,0.0001211865,0.00007768014,0.0002259712,0.0001372996],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001029527,"about_ca_system_score_gemma":0.0002551266,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004628391,"about_ca_topic_score_gemma":0.0000389277,"domain_scores_codex":[0.9989366,0.0001797672,0.0001780461,0.0003272701,0.0002029717,0.0001753646],"domain_scores_gemma":[0.999327,0.0001145708,0.00002994204,0.0003535259,0.00006432388,0.0001106101],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.0002225802,0.0001833793,0.6183327,0.0009971191,0.0003745882,0.0002906763,0.001306113,4.059746e-7,0.002152321,0.0007381015,0.07147446,0.3039276],"study_design_scores_gemma":[0.002106909,0.0001532805,0.754485,0.0007340682,0.001121704,0.0003349365,0.0006563739,0.007953249,0.0003996187,0.005460818,0.2262687,0.0003253857],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8467354,0.1477205,0.00001531299,0.002603019,0.000429504,0.0003059367,0.00004099856,0.000116832,0.002032511],"genre_scores_gemma":[0.9940315,0.003999466,0.0002503619,0.0003610932,0.0001949011,0.00003706712,0.0001435594,0.00002695812,0.000955056],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.3036022,"threshold_uncertainty_score":0.8474114,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01797591256930351,"score_gpt":0.2776136475974494,"score_spread":0.2596377350281459,"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."}}