{"id":"W2950775431","doi":"10.1016/j.jcyt.2019.03.005","title":"Current state of Health Canada regulation for cellular and gene therapy products: potential cures on the horizon","year":2019,"lang":"en","type":"review","venue":"Cytotherapy","topic":"Biomedical Ethics and Regulation","field":"Medicine","cited_by":26,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of Toronto; International Society for Cellular Therapy; University Health Network","funders":"Health Canada","keywords":"Regulatory authority; Government regulation; Business; Product (mathematics); Government (linguistics); Food and drug administration; State (computer science); Risk analysis (engineering); Political science; Public administration; Computer science","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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0007563398,0.0002631405,0.001028852,0.00009087049,0.00009710298,0.00001323427,0.00009871419,0.0001346247,0.00001538205],"category_scores_gemma":[0.00001843239,0.0001382899,0.0001578062,0.0001775034,0.0001828169,0.00001484908,0.000009692295,0.0003033777,6.472868e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001455765,"about_ca_system_score_gemma":0.002510285,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002492778,"about_ca_topic_score_gemma":0.000532564,"domain_scores_codex":[0.9981955,0.0001927647,0.0005885257,0.0003595969,0.000451653,0.0002119183],"domain_scores_gemma":[0.9986442,0.0001211338,0.0005957169,0.0004120716,0.0001541661,0.00007270113],"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":[0.00007303696,0.00005857934,3.668206e-7,0.007959479,0.0001318587,3.014926e-7,0.00005102239,0.000001452551,0.000153912,0.0003015152,0.002113135,0.9891554],"study_design_scores_gemma":[0.0006908592,0.0007791499,0.00005287728,0.00453007,0.00008099421,0.000004361581,0.000002748257,0.00007222943,0.0002228029,0.0005238217,0.992904,0.0001360944],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0002855475,0.988038,0.0010254,0.006375886,0.0007097513,0.003440996,0.0001099007,0.0000105778,0.000003951948],"genre_scores_gemma":[0.0005423482,0.997988,0.00009121913,0.0002575956,0.0004302311,0.00006653569,0.0003998343,0.00005456025,0.0001696366],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9907908,"threshold_uncertainty_score":0.5639301,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08385797808713917,"score_gpt":0.3539261606220959,"score_spread":0.2700681825349567,"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."}}