{"id":"W2959919038","doi":"","title":"Drug Product Registration in US, EUROPE, JAPAN and CANADA for New Drug and Generics","year":2014,"lang":"en","type":"article","venue":"","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Drug; Product (mathematics); Business; Drug approval; Approved drug; Marketing; Drug development; 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":[0.00155813,0.0003930351,0.000493938,0.004950895,0.001873775,0.003206077,0.0007079169,0.001341352,0.0419198],"category_scores_gemma":[0.006682524,0.000232351,0.000650252,0.008632703,0.001499277,0.001977806,0.0007190435,0.001559372,0.01471782],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01178421,"about_ca_system_score_gemma":0.02354585,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.3180976,"about_ca_topic_score_gemma":0.3014818,"domain_scores_codex":[0.9960266,0.0003390692,0.0002786016,0.0003797024,0.002496743,0.0004792215],"domain_scores_gemma":[0.9947851,0.000614097,0.0005799229,0.0003766275,0.003291179,0.0003531293],"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":[0.0001562459,0.0001163007,0.01468466,0.0007968492,0.00005591581,0.0003803243,0.0006324832,0.0008448524,0.0013964,0.3568397,0.4355302,0.1885662],"study_design_scores_gemma":[0.00001930331,0.00003521881,0.01996759,0.0001553405,0.0000258977,0.0002386434,0.0002730467,0.0006097776,0.0006210796,0.007368964,0.9706532,0.00003198969],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"review","genre_scores_codex":[0.01182562,0.006448907,0.007536129,0.006692846,0.0008573209,0.0007292782,0.02703485,0.0007684418,0.9381067],"genre_scores_gemma":[0.3225313,0.01953144,0.0255311,0.004785941,0.0009896086,0.0005885343,0.0426509,0.0004787256,0.5829125],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.6819024,"threshold_uncertainty_score":0.6324921,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03460662745522742,"score_gpt":0.2382060936486098,"score_spread":0.2035994661933824,"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."}}