{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.004472045,0.0006238102,0.003458003,0.0002781592,0.0003266712,0.00003084456,0.0003486086,0.001904218,0.0002810426],"category_scores_gemma":[0.001334601,0.0005287788,0.0003749713,0.0001881296,0.0021276,0.00006031395,0.0003850406,0.001103282,0.000007805478],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001255161,"about_ca_system_score_gemma":0.002797805,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001958859,"about_ca_topic_score_gemma":0.01936652,"domain_scores_codex":[0.9926242,0.002021805,0.003326071,0.001225385,0.00007737061,0.0007252119],"domain_scores_gemma":[0.9954913,0.002953298,0.0007469854,0.0003159196,0.0003074879,0.0001849951],"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":[0.0001122182,0.0001487259,0.01124396,0.001227939,0.001859194,0.00002662094,0.00001417864,4.19947e-8,0.0000125324,0.0000685572,0.7640405,0.2212455],"study_design_scores_gemma":[0.001995758,0.0001698863,0.004669274,0.0005445047,0.001192921,0.00009497788,0.00001470154,0.00002731072,0.0000406083,0.0002247133,0.990409,0.000616352],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0008893008,0.9838852,0.001421176,0.001029845,0.01082608,0.001365769,0.0004647975,0.0000198661,0.0000979527],"genre_scores_gemma":[0.0000340535,0.9353418,0.05770477,0.004559084,0.000592696,0.00009421531,0.0001634777,0.00004981552,0.001460048],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.2263685,"threshold_uncertainty_score":0.9997164,"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."}}