{"id":"W2738563879","doi":"10.18579/jpcrkc/2017/16/2/116432","title":"Drug Master File Filing in US, Europe, Canada and Australia","year":2017,"lang":"en","type":"article","venue":"Journal of Pharmaceutical Research","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":3,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Drug; Business; Medicine; Pharmacology","routes":{"ca_aff":false,"ca_fund":false,"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":[0.01243147,0.0004890913,0.000633257,0.006936943,0.006121449,0.009763529,0.001925791,0.002218961,0.05327413],"category_scores_gemma":[0.05865678,0.0005008104,0.0009137266,0.006998545,0.002428631,0.00537396,0.002973442,0.002363403,0.01955203],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.03035934,"about_ca_system_score_gemma":0.07273229,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.5598211,"about_ca_topic_score_gemma":0.4959344,"domain_scores_codex":[0.9655278,0.002475694,0.002019475,0.002448114,0.02257865,0.004950229],"domain_scores_gemma":[0.9286219,0.005848921,0.003565532,0.003736267,0.05292184,0.005305396],"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":[0.0005246839,0.0002412709,0.02815421,0.001050805,0.00005389004,0.0007950935,0.005760451,0.0005857743,0.002737864,0.09388395,0.6529016,0.2133104],"study_design_scores_gemma":[0.0000543836,0.000100311,0.06853978,0.0007360777,0.00003064991,0.0005895579,0.003821543,0.0003772746,0.002386366,0.001444134,0.9217851,0.0001347679],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.06202718,0.005407447,0.005629557,0.02614119,0.002525857,0.002929216,0.02524929,0.002941486,0.8671486],"genre_scores_gemma":[0.3494495,0.009696012,0.01982108,0.02391653,0.0007184321,0.001587453,0.03428362,0.003099004,0.5574283],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.4401789,"threshold_uncertainty_score":0.8855423,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3834213812101235,"score_gpt":0.4595554708074974,"score_spread":0.07613408959737389,"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."}}