{"id":"W2821537775","doi":"10.22270/ijdra.v6i2.236","title":"Regulatory requirements for Drug master file in context to Canada and Australia","year":2018,"lang":"en","type":"article","venue":"International Journal of Drug Regulatory Affairs","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":1,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Health Canada","keywords":"Legislation; Context (archaeology); Terminology; Drug; Business; Quality (philosophy); Product (mathematics); Computer science; Political science; Pharmacology; Medicine; Law; Biology","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.02080959,0.0005542929,0.000943643,0.005379919,0.006524208,0.008290418,0.004654973,0.005993332,0.05861229],"category_scores_gemma":[0.07911436,0.001264516,0.001168816,0.005098751,0.003095787,0.003657264,0.003114523,0.004000229,0.0297804],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0246858,"about_ca_system_score_gemma":0.09738255,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.5827163,"about_ca_topic_score_gemma":0.5265082,"domain_scores_codex":[0.9622577,0.004248557,0.002915999,0.002944087,0.02371123,0.003922336],"domain_scores_gemma":[0.8820846,0.01527812,0.003206321,0.00956036,0.08590235,0.003968173],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00036453,0.0002024021,0.003046443,0.0008388471,0.00002333961,0.0008463169,0.00281728,0.0006285614,0.00493617,0.08451474,0.8118141,0.08996727],"study_design_scores_gemma":[0.00003364804,0.00004398596,0.008210308,0.0003977778,0.00001539718,0.000272277,0.0003256185,0.0003064369,0.001618208,0.001043494,0.9876666,0.00006619272],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.018629,0.003478865,0.01780646,0.03322114,0.003491369,0.009549506,0.03290772,0.007926133,0.8729897],"genre_scores_gemma":[0.1090049,0.004463845,0.0448616,0.04162797,0.001027357,0.007199219,0.02873032,0.002527746,0.7605571],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.4172837,"threshold_uncertainty_score":0.8394824,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05655171049066777,"score_gpt":0.2988763481879289,"score_spread":0.2423246376972611,"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."}}