{"id":"W4395004529","doi":"10.1136/bmjgh-2024-015122","title":"Quality and safety for substances of human origins: scientific evidence and the new EU regulations","year":2024,"lang":"en","type":"article","venue":"BMJ Global Health","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":11,"is_retracted":false,"has_abstract":true,"ca_institutions":"University of Toronto","funders":"","keywords":"Quality (philosophy); Scientific evidence; Human health; Public health; Business; Environmental health; Political science; Risk analysis (engineering); Engineering ethics; Medicine; Engineering; Nursing; Epistemology; Philosophy","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":[0.002550846,0.00007636387,0.00029688,0.00004479733,0.0002575049,0.0001486029,0.0001079073,0.00003201529,0.00002273797],"category_scores_gemma":[0.0001300853,0.00006566625,0.00005946811,0.0002005535,0.0002916887,0.0001683014,0.00003757327,0.0000533828,0.000009358208],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001692656,"about_ca_system_score_gemma":0.0002035948,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001500342,"about_ca_topic_score_gemma":0.000690095,"domain_scores_codex":[0.9988026,0.00002848009,0.0006513359,0.0002940831,0.00002460044,0.0001989005],"domain_scores_gemma":[0.9992042,0.0002634868,0.0001960463,0.0001858259,0.00001765051,0.0001327716],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.00004002022,0.000007483181,0.002106013,0.0001909899,0.00001435059,5.413152e-8,0.0002343148,0.00000774191,9.670032e-7,0.9858893,0.005266478,0.006242353],"study_design_scores_gemma":[0.0006949118,0.00004241696,0.03870825,0.00009859615,0.000004922933,0.000002705595,0.00003181538,0.006034425,0.000003780411,0.6971124,0.2571624,0.000103356],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":"theoretical_or_conceptual","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.5244029,0.2235774,0.006529844,0.2254796,0.001923606,0.002918498,0.003364881,0.00007809012,0.01172511],"genre_scores_gemma":[0.9958522,0.00205971,0.0003883989,0.001266717,0.0001382196,0.00001560702,0.000007570764,0.000005173172,0.0002664097],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4714493,"threshold_uncertainty_score":0.2677792,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2483557773370478,"score_gpt":0.4884743484454923,"score_spread":0.2401185711084446,"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."}}