{"id":"W6967809012","doi":"10.5281/zenodo.1079863","title":"Generic Drug In Global Market And Regulatory Environment","year":2017,"lang":"en","type":"article","venue":"Zenodo (CERN European Organization for Nuclear Research)","topic":"Pharmaceutical Quality and Counterfeiting","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Generic drug; Regulatory agency; Harmonization; Drug development; Agency (philosophy); Regulatory affairs; Pharmaceutical industry; Good manufacturing practice; Drug; Regulatory science","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":"codex-gemma-dda1882f352a","candidate_categories":["insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.0006745906,0.00007623429,0.0001098888,0.00004072099,0.00102913,0.0002690955,0.0002851142,0.00003183653,0.005005421],"category_scores_gemma":[0.0002782472,0.00007851202,0.00002147958,0.00005230317,0.0002094544,0.0001379908,0.0007235806,0.0001547883,0.0007695358],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001439619,"about_ca_system_score_gemma":0.000002187868,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00001716092,"about_ca_topic_score_gemma":2.996051e-7,"domain_scores_codex":[0.9990367,0.000142228,0.0001462333,0.0002418631,0.0002217956,0.0002112031],"domain_scores_gemma":[0.9993629,0.000008678849,0.00005918932,0.0003668253,0.00004408487,0.0001582582],"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":[0.0009051927,0.0006287426,0.003803833,0.0005007726,0.0001171197,0.0002795356,0.001426445,0.00001410537,0.01169934,0.007469773,0.1443457,0.8288094],"study_design_scores_gemma":[0.001152024,0.00007733935,0.1404033,0.00006227456,0.00001810569,0.0001526329,0.0002323083,0.0009108488,0.0003046242,0.0002633716,0.8563057,0.0001174577],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.7755396,0.0002216058,0.0001965435,0.003097731,0.0000409772,0.0002786968,0.00005289958,0.0001431167,0.2204288],"genre_scores_gemma":[0.9980824,0.0001750906,0.00009992089,0.0003227016,0.00007424785,1.861326e-8,0.00005755267,0.0001980898,0.0009899853],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.828692,"threshold_uncertainty_score":0.9959041,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.06007239745947099,"score_gpt":0.305635021432849,"score_spread":0.245562623973378,"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."}}