{"id":"W2889574927","doi":"10.3389/fphar.2018.01079","title":"Quality, Non-clinical and Clinical Considerations for Biosimilar Monoclonal Antibody Development: EU, WHO, USA, Canada, and BRICS-TM Regulatory Guidelines","year":2018,"lang":"en","type":"review","venue":"Frontiers in Pharmacology","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":36,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Health Canada; U.S. Food and Drug Administration; World Health Organization","keywords":"Biosimilar; Authorization; Marketing authorization; Quality (philosophy); Medicine; Regulatory science; Business; Bioinformatics; Computer science; Internal medicine; Computer security; Biology","routes":{"ca_aff":false,"ca_fund":true,"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":[0.1213201,0.0006854996,0.001262125,0.006514887,0.002428002,0.008291638,0.00340346,0.004460562,0.002388677],"category_scores_gemma":[0.128444,0.0005240064,0.001407325,0.008463219,0.006135035,0.004554769,0.002596575,0.004288595,0.0003765957],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.03110141,"about_ca_system_score_gemma":0.170402,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.3220005,"about_ca_topic_score_gemma":0.3056644,"domain_scores_codex":[0.8934091,0.0385036,0.01414226,0.003129717,0.04708374,0.003731509],"domain_scores_gemma":[0.7725772,0.1052304,0.01494294,0.003706109,0.1006475,0.002895885],"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":[0.0003412009,0.0001814323,0.009316339,0.05634302,0.0003627409,0.0006809232,0.01556011,0.001279843,0.002962253,0.1903654,0.2544911,0.4681156],"study_design_scores_gemma":[0.00005162773,0.0001096633,0.01271752,0.07205129,0.0005058339,0.0003215285,0.01147829,0.0003269776,0.001584708,0.009947845,0.8907884,0.0001162056],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.01587728,0.6408449,0.009848512,0.2280528,0.003649975,0.002135081,0.005910651,0.0002090916,0.09347174],"genre_scores_gemma":[0.3097851,0.4057359,0.07195272,0.18522,0.001441781,0.003787058,0.007811747,0.0003169558,0.01394871],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.6779995,"threshold_uncertainty_score":0.6416094,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1978419109622758,"score_gpt":0.5028874777871456,"score_spread":0.3050455668248698,"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."}}