{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.002287409,0.000153975,0.0002605471,0.004386587,0.00157198,0.002347559,0.0005754774,0.0003105273,0.003523003],"category_scores_gemma":[0.006559885,0.0001325693,0.0004800461,0.00964011,0.001254154,0.0007046964,0.0009597953,0.0005997519,0.0003485873],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.02095473,"about_ca_system_score_gemma":0.02332919,"about_ca_topic_candidate":true,"about_ca_topic_consensus":true,"about_ca_topic_score_codex":0.8721673,"about_ca_topic_score_gemma":0.9248148,"domain_scores_codex":[0.9960354,0.0004596642,0.0002790359,0.0002228603,0.002103406,0.0008996922],"domain_scores_gemma":[0.991203,0.00126585,0.001911208,0.0002046056,0.004519143,0.0008962344],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.0006970747,0.0001319759,0.8097125,0.0004963402,0.0002792473,0.001338379,0.01469608,0.001087968,0.001464257,0.05093222,0.01389715,0.1052669],"study_design_scores_gemma":[0.000005970744,0.00007094218,0.9641773,0.00007841246,0.00004722605,0.0001939402,0.007420149,0.0003081209,0.0003201909,0.0002264845,0.02712974,0.00002162313],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8545343,0.007681444,0.0005448775,0.002324833,0.00007896406,0.00008217018,0.002309247,0.00006613147,0.132378],"genre_scores_gemma":[0.9865723,0.002236894,0.0002719206,0.0004535032,0.00001637828,0.00001808819,0.0009841396,0.00001846086,0.009428277],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1278327,"threshold_uncertainty_score":0.257171,"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."}}