{"id":"W2087287783","doi":"10.1016/j.biologicals.2007.11.004","title":"WHO informal consultation on regulatory evaluation of therapeutic biological medicinal products held at WHO Headquarters, Geneva, 19–20 April 2007","year":2008,"lang":"en","type":"article","venue":"Biologicals","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":40,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"","keywords":"Biosimilar; Terminology; Innovator; Product (mathematics); Medicine; Business; Quality (philosophy); Regulatory science; Political science; Intellectual property; Law","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01765233,0.00143949,0.0009780253,0.001343729,0.005132492,0.003469761,0.00211844,0.02309053,0.01854634],"category_scores_gemma":[0.0174834,0.0007405659,0.001418102,0.0009351657,0.002796708,0.002106761,0.004083665,0.009818926,0.003744091],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00615735,"about_ca_system_score_gemma":0.0187453,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.02314756,"about_ca_topic_score_gemma":0.03912709,"domain_scores_codex":[0.9898169,0.004605405,0.0007687282,0.0005108104,0.002223223,0.002074862],"domain_scores_gemma":[0.9837241,0.007709337,0.00130932,0.0004917529,0.004840953,0.001924508],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0004867881,0.0001059004,0.001863794,0.0007013967,0.00004465725,0.003080284,0.002792382,0.0002037449,0.008280401,0.003580463,0.9540884,0.02477183],"study_design_scores_gemma":[0.0001026141,0.0001165921,0.003677346,0.0006616014,0.00005220178,0.0006092136,0.002523303,0.0001871326,0.002884683,0.001229382,0.987899,0.00005693459],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.02270854,0.02722315,0.007877112,0.770609,0.05216991,0.002020355,0.003821131,0.0004923038,0.1130785],"genre_scores_gemma":[0.1113053,0.01143213,0.01115973,0.464667,0.01783187,0.001468173,0.002328341,0.0006797346,0.3791278],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.02314756,"threshold_uncertainty_score":0.09335548,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1320325286439629,"score_gpt":0.3391617240837612,"score_spread":0.2071291954397983,"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."}}