{"id":"W4238788977","doi":"10.1177/2168479018811889","title":"Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements","year":2019,"lang":"en","type":"article","venue":"Therapeutic Innovation & Regulatory Science","topic":"Pharmaceutical studies and practices","field":"Medicine","cited_by":4,"is_retracted":false,"has_abstract":true,"ca_institutions":"Université de Montréal","funders":"American Association of Pharmaceutical Scientists","keywords":"Medicine; New drug application; Pharmacy; Drug; Pharmacology; Approved drug; Risk analysis (engineering); Medical physics; 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":[0.003685758,0.0001696316,0.0003021809,0.000190029,0.000287843,0.00002487328,0.0002367001,0.00003326362,0.0001445269],"category_scores_gemma":[0.0000569981,0.0001113992,0.00003456677,0.002159248,0.0005782659,0.0003956811,0.0001511524,0.0001778651,0.00001316278],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001418764,"about_ca_system_score_gemma":0.0003217195,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000006335285,"about_ca_topic_score_gemma":6.085769e-7,"domain_scores_codex":[0.9978622,0.00006299005,0.0005792389,0.0003589919,0.0008452911,0.0002913129],"domain_scores_gemma":[0.9985585,0.00008680508,0.0004027561,0.0004675004,0.0004236448,0.00006084971],"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":[0.0001309555,0.0001000785,0.004552296,0.001985333,0.0001264992,7.208489e-7,0.00153724,0.000003304169,0.1928171,0.007893234,0.0002729364,0.7905803],"study_design_scores_gemma":[0.002125329,0.0002247161,0.3069707,0.004078036,0.0001708651,0.00003794943,0.000677613,0.0008154025,0.1224303,0.0009692773,0.5609469,0.0005528941],"study_design_candidate":"design_other","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9719999,0.01572194,0.000101067,0.004601594,0.0003121057,0.0006092747,0.000001273698,0.00004216014,0.006610664],"genre_scores_gemma":[0.9893968,0.0008168783,0.000380295,0.008409136,0.00003703931,0.0000174001,0.000003936168,0.00001220848,0.0009263529],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.7900274,"threshold_uncertainty_score":0.4542727,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05223078935574084,"score_gpt":0.3414882531716082,"score_spread":0.2892574638158674,"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."}}