{"id":"W791093694","doi":"10.1016/j.biologicals.2015.05.013","title":"The regulation of cell therapy products in Canada","year":2015,"lang":"en","type":"article","venue":"Biologicals","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":8,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"Health Canada","keywords":"Harmonization; Business; Transplantation; Regulatory authority; Product (mathematics); Risk analysis (engineering); Food and drug administration; Biotechnology; Medicine; Biology; Political science; Public administration","routes":{"ca_aff":true,"ca_fund":true,"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":[],"consensus_categories":[],"category_scores_codex":[0.007886625,0.0003487226,0.0005306886,0.002082119,0.01147249,0.009391814,0.002285194,0.008331908,0.006254822],"category_scores_gemma":[0.01776462,0.0007868449,0.0008057983,0.002471739,0.006345674,0.001335494,0.002489041,0.006648519,0.0004460278],"about_ca_system_candidate":true,"about_ca_system_consensus":true,"about_ca_system_score_codex":0.2013306,"about_ca_system_score_gemma":0.3543749,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.9897495,"about_ca_topic_score_gemma":0.9922547,"domain_scores_codex":[0.9835803,0.001673153,0.00046302,0.001128944,0.008760336,0.004394291],"domain_scores_gemma":[0.9760436,0.006530963,0.001255339,0.0005324417,0.01096899,0.004668646],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0002189726,0.0001694162,0.01441017,0.0003100198,0.00008334732,0.001136586,0.005345021,0.002916584,0.004304979,0.8212945,0.09992184,0.04988855],"study_design_scores_gemma":[0.000094028,0.0001091892,0.04508376,0.0004887632,0.00006962755,0.0002032061,0.002481032,0.002726624,0.00259944,0.01735147,0.9285912,0.0002015597],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.1803071,0.02606031,0.004873417,0.313578,0.002356529,0.0005500641,0.001784281,0.0002163318,0.470274],"genre_scores_gemma":[0.6722154,0.008878842,0.005481488,0.06040152,0.0003891892,0.0002030027,0.0003895843,0.000100172,0.2519408],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.7986693,"threshold_uncertainty_score":0.9263433,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08397976924490445,"score_gpt":0.2883434570020226,"score_spread":0.2043636877571182,"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."}}