{"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":"codex-gemma-dda1882f352a","candidate_categories":["insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.002553769,0.0002937486,0.0006324606,0.00009399363,0.0002647961,0.000005001803,0.0002484291,0.0007783324,0.001726993],"category_scores_gemma":[0.001386179,0.0001740601,0.0001467331,0.0002546363,0.001359936,0.00005400704,0.00008393221,0.0002982139,0.000155694],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00008739412,"about_ca_system_score_gemma":0.0001251343,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000008875912,"about_ca_topic_score_gemma":0.000002446875,"domain_scores_codex":[0.9968617,0.001258228,0.0006912543,0.0005280093,0.0001982499,0.0004625554],"domain_scores_gemma":[0.9981635,0.0006481498,0.0003236415,0.0003897702,0.0004065237,0.00006836702],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"observational","study_design_scores_codex":[0.003296977,0.0007599291,0.04256262,0.00006397763,0.00056154,0.00001187384,0.0006631205,0.00003298176,0.8460442,0.003602861,0.03151661,0.07088328],"study_design_scores_gemma":[0.004441442,0.005119964,0.6554263,0.0001027524,0.0002331436,0.0002050485,0.0002315324,0.0001460899,0.2543437,0.0007650167,0.07833256,0.0006525142],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9871858,0.007576816,0.0001086345,0.001145954,0.0004932043,0.00075596,0.00006998104,0.0000698494,0.002593759],"genre_scores_gemma":[0.9950498,0.0005807597,0.0003379929,0.002273614,0.0001281606,0.00004080308,0.0001641917,0.00000851973,0.001416194],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.6128637,"threshold_uncertainty_score":0.9991856,"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."}}