{"id":"W1989847611","doi":"10.1016/j.biologicals.2011.06.015","title":"Quality, safety and efficacy of follow-on biologics in Japan","year":2011,"lang":"en","type":"review","venue":"Biologicals","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":24,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Comparability; Harmonization; Medicine; Quality (philosophy); Product (mathematics); Scientific evidence; Drug approval; Pharmacovigilance; Risk analysis (engineering); Business; Pharmacology; Adverse effect; Internal medicine; Drug","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":[0.003344791,0.0004848821,0.001284679,0.001703645,0.0003379303,0.001188803,0.0006631087,0.001216759,0.001020866],"category_scores_gemma":[0.002741657,0.0002646036,0.0005318173,0.001851533,0.0007518507,0.001116802,0.0005513745,0.0009510272,0.0003495524],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00151006,"about_ca_system_score_gemma":0.00293848,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004313618,"about_ca_topic_score_gemma":0.004360214,"domain_scores_codex":[0.9983187,0.0003281534,0.0004251049,0.0002160662,0.0006425685,0.00006952524],"domain_scores_gemma":[0.9981615,0.0006681317,0.0005086262,0.00004359505,0.0005585351,0.00005960486],"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":[0.0001152607,0.00005947931,0.001040205,0.01803992,0.0000793732,0.0002646593,0.000192975,0.000199524,0.002508836,0.003381752,0.005866485,0.9682514],"study_design_scores_gemma":[0.00005458789,0.000560512,0.01334837,0.009427338,0.0005333712,0.003681679,0.0004557798,0.0002629262,0.009213671,0.002936531,0.9594592,0.00006590047],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0005204319,0.9983289,0.00009350441,0.0002765394,0.00005541892,0.000004869892,0.000008190749,0.000001905383,0.0007102097],"genre_scores_gemma":[0.006428613,0.9923885,0.0003921218,0.0002167466,0.0001141069,0.00001349219,0.00002553377,0.00000170353,0.0004190366],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.004313618,"threshold_uncertainty_score":0.01768917,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2219666777781518,"score_gpt":0.4229495287818701,"score_spread":0.2009828510037183,"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."}}