{"id":"W2908941652","doi":"10.1007/s43441-019-00036-y","title":"Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements","year":2020,"lang":"en","type":"article","venue":"Therapeutic Innovation & Regulatory Science","topic":"Pharmaceutical studies and practices","field":"Medicine","cited_by":34,"is_retracted":false,"has_abstract":true,"ca_institutions":"Université de Montréal","funders":"","keywords":"Medicine; New drug application; Pharmacy; Drug; Approved drug; Pharmacology; Risk analysis (engineering); Family medicine","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":[0.002476226,0.0001679249,0.0002945444,0.0001149112,0.0003626632,0.00002532173,0.0002407195,0.00002924562,0.00008162154],"category_scores_gemma":[0.0001202495,0.0001123661,0.00003399312,0.002579002,0.0007058321,0.0003479367,0.0001637686,0.0001875358,0.000005559295],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00009790374,"about_ca_system_score_gemma":0.0003162686,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000004075092,"about_ca_topic_score_gemma":3.966249e-7,"domain_scores_codex":[0.9979093,0.00006489038,0.000593231,0.0003600345,0.0008062501,0.0002662713],"domain_scores_gemma":[0.9987558,0.00007148072,0.000377323,0.000306833,0.0003895364,0.00009910252],"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":[0.0001519048,0.00007034808,0.0012237,0.001866444,0.0001190863,0.00000142221,0.003060412,0.000003120497,0.1603202,0.004883732,0.0005710261,0.8277286],"study_design_scores_gemma":[0.001944129,0.000264282,0.1221247,0.002598625,0.0002235805,0.00002663672,0.000833496,0.001540115,0.1519389,0.0006262252,0.7173316,0.0005477093],"study_design_candidate":"design_other","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9063211,0.03792631,0.0007443354,0.04698708,0.00032011,0.000959409,0.000003573466,0.0001152572,0.006622788],"genre_scores_gemma":[0.9716134,0.0009411318,0.0005343609,0.02665385,0.00006460516,0.00001729856,0.000003884279,0.00001198358,0.0001594916],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.8271809,"threshold_uncertainty_score":0.4582156,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.08448228183349814,"score_gpt":0.3486671360293755,"score_spread":0.2641848541958773,"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."}}