{"id":"W4398198877","doi":"10.1016/j.jcyt.2024.03.219","title":"REGULATORY GUIDANCE FOR PRECLINICAL STUDIES OF CELL THERAPIES: PILOT SYNTHESIS OF HEALTH CANADA, FDA, AND EMA PERSPECTIVES","year":2024,"lang":"en","type":"article","venue":"Cytotherapy","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"Ottawa Hospital; University of Ottawa","funders":"","keywords":"Medicine; Drug approval; Pharmacology; Drug","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.1440152,0.00130518,0.001856287,0.003784994,0.005886044,0.01413209,0.00613735,0.02422309,0.01067549],"category_scores_gemma":[0.1362803,0.0009677523,0.002785968,0.003053203,0.01252532,0.004185295,0.003838939,0.01848149,0.001483662],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.03472165,"about_ca_system_score_gemma":0.2985352,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.3846132,"about_ca_topic_score_gemma":0.4935616,"domain_scores_codex":[0.9200337,0.02808064,0.003289189,0.003793257,0.03851742,0.006285756],"domain_scores_gemma":[0.7248528,0.1468022,0.006521043,0.005723985,0.1061632,0.009936782],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0006543249,0.00054086,0.002013202,0.002595374,0.0001243995,0.0004470793,0.003065215,0.001371121,0.009528451,0.3468159,0.4975837,0.1352603],"study_design_scores_gemma":[0.0004104831,0.0003766339,0.004682849,0.005056348,0.0002743927,0.0001966146,0.001555913,0.0005404816,0.00435621,0.03188252,0.9505424,0.0001252475],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"review","genre_scores_codex":[0.009332001,0.0604137,0.01482019,0.7599765,0.007781019,0.001974338,0.002887675,0.0003596129,0.142455],"genre_scores_gemma":[0.1299826,0.05155918,0.06387209,0.6924549,0.003494453,0.002977825,0.001987969,0.0002863484,0.05338462],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.9652783,"threshold_uncertainty_score":0.7647489,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.07620384852891501,"score_gpt":0.3893276784046861,"score_spread":0.313123829875771,"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."}}