{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.004929469,0.0008108411,0.001803183,0.002745706,0.001364448,0.004796665,0.001804901,0.004787993,0.006913352],"category_scores_gemma":[0.007394154,0.0003525095,0.0006431324,0.003815297,0.004201414,0.002732053,0.001592509,0.005524667,0.001486487],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01569649,"about_ca_system_score_gemma":0.05539977,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.118047,"about_ca_topic_score_gemma":0.18945,"domain_scores_codex":[0.9975447,0.0004336918,0.00018037,0.0001980157,0.001363585,0.0002794952],"domain_scores_gemma":[0.9912741,0.005170912,0.0006281487,0.0001514571,0.002309691,0.0004656438],"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":[0.00006037959,0.00005760104,0.000198703,0.01335938,0.00004568779,0.0001729661,0.0003331037,0.0004108038,0.0007814034,0.08530737,0.1890975,0.7101752],"study_design_scores_gemma":[0.000004529654,0.000009819977,0.0002533995,0.005119359,0.00002586785,0.00009823569,0.0001049864,0.00003285959,0.00009885511,0.003968042,0.9902725,0.00001151761],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.00006802409,0.9856728,0.0001560915,0.009082626,0.0006683472,0.000005212354,0.00003977126,0.00001156862,0.004295568],"genre_scores_gemma":[0.001486113,0.988836,0.0003222917,0.006663706,0.0004847528,0.00001051764,0.00004269701,0.000005133431,0.002148802],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9843035,"threshold_uncertainty_score":0.2347197,"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."}}