{"id":"W1239449858","doi":"10.2165/11599720-000000000-00000","title":"Impact of Regulatory Guidances and Drug Regulation on Risk Minimization Interventions in Drug Safety","year":2012,"lang":"en","type":"review","venue":"Drug Safety","topic":"Pharmacovigilance and Adverse Drug Reactions","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":17,"is_retracted":false,"has_abstract":false,"ca_institutions":"Université de Montréal","funders":"Canadian Patient Safety Institute; Golden Key International Honour Society","keywords":"Medicine; Psychological intervention; Drug; Agency (philosophy); MEDLINE; Pharmacovigilance; Population; Adverse effect; Regulatory science; Intensive care medicine; Pharmacology; Environmental health; Psychiatry","routes":{"ca_aff":true,"ca_fund":true,"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":["metaepi_narrow","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.002309994,0.000696625,0.001664022,0.0006662846,0.0003546062,0.0000190275,0.0003700063,0.000473745,0.0009773627],"category_scores_gemma":[0.0001380245,0.0006106534,0.001137806,0.0007322154,0.0003011157,0.0004504807,0.0001412145,0.001648479,0.0001131967],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0006576562,"about_ca_system_score_gemma":0.0003188443,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0002206802,"about_ca_topic_score_gemma":0.0001344313,"domain_scores_codex":[0.9944572,0.00223931,0.001790276,0.0006432029,0.0002735818,0.0005964609],"domain_scores_gemma":[0.9960694,0.001376705,0.001641243,0.0005022688,0.0001166138,0.0002937359],"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":[0.0005712096,0.001308151,0.004460373,0.007653367,0.001237045,0.000009826348,0.001858684,0.003709485,0.00001848255,0.001027603,0.01073394,0.9674118],"study_design_scores_gemma":[0.001489601,0.00003211603,0.009104974,0.004591769,0.002302045,0.00001871812,0.0001095839,0.0003307314,0.00003894395,0.0001164107,0.9812443,0.0006208674],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.004639821,0.9841906,0.00003693579,0.0001007637,0.001629236,0.001640731,0.002147506,0.000107823,0.005506561],"genre_scores_gemma":[0.04745792,0.948613,0.00006970669,0.00004970922,0.0004217156,0.000107107,0.00085813,0.00007497854,0.002347701],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9705103,"threshold_uncertainty_score":0.9999359,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1358083373969537,"score_gpt":0.4777817785596545,"score_spread":0.3419734411627008,"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."}}