{"id":"W4313464260","doi":"10.22270/ijdra.v10i2.518","title":"A Comparative Study of Biologic Regulation in US, Canada, Australia, Europe and Singapore","year":2022,"lang":"en","type":"article","venue":"International Journal of Drug Regulatory Affairs","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Regulatory science; Product (mathematics); Regulatory authority; Order (exchange); Business; Quality (philosophy); Control (management); New product development; Developed country; International trade; Political science; Public administration; Marketing; Medicine; Economics; Environmental health; Management; Finance","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":[],"consensus_categories":[],"category_scores_codex":[0.0006896819,0.0001009944,0.0003020282,0.0002017369,0.00005771167,0.000006946926,0.0002865764,0.00003880187,0.0004297254],"category_scores_gemma":[0.00005327702,0.00008320534,0.00004526157,0.0001504865,0.0001321211,0.00006417147,0.0001328274,0.0003276429,5.488052e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001406575,"about_ca_system_score_gemma":0.0001302476,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.006406193,"about_ca_topic_score_gemma":0.02613745,"domain_scores_codex":[0.9984788,0.0005563081,0.0005519788,0.0001381332,0.0001634727,0.0001113567],"domain_scores_gemma":[0.9990298,0.000143344,0.0004785118,0.00008614476,0.0002397375,0.00002251929],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.002906286,0.002968062,0.800583,0.00002371962,0.002398833,0.0003982603,0.006686024,0.00454458,0.1543005,0.003174354,0.01901828,0.00299816],"study_design_scores_gemma":[0.002637567,0.0007749413,0.9642981,0.00004074673,0.00007192601,0.0003329268,0.01180919,0.00004217391,0.01128846,0.0003523086,0.008179413,0.0001722945],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9980291,0.000371412,0.000005538559,0.0004740483,0.0007606968,0.0001016449,0.00002948079,0.000002324432,0.0002257405],"genre_scores_gemma":[0.9991342,0.00000674317,0.00009821542,0.00004302012,0.00002654968,0.000001837343,0.000005852926,0.000003886176,0.000679724],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.163715,"threshold_uncertainty_score":0.991633,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03078367434811793,"score_gpt":0.3029877999982529,"score_spread":0.272204125650135,"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."}}