{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","research_integrity"],"consensus_categories":[],"category_scores_codex":[0.001913332,0.0005062629,0.00321357,0.0001986637,0.00005376551,0.000005820824,0.0004662525,0.002292026,0.000614111],"category_scores_gemma":[0.001415695,0.0002660542,0.000562725,0.0003005942,0.0007862872,0.00001266336,0.0003178852,0.000703184,0.00009599307],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00003202589,"about_ca_system_score_gemma":0.0000472352,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00002672452,"about_ca_topic_score_gemma":0.000005235285,"domain_scores_codex":[0.9952464,0.002139224,0.001413571,0.00072245,0.00002590793,0.0004524097],"domain_scores_gemma":[0.9961551,0.002745726,0.0005660819,0.0004567117,0.00003368955,0.00004271639],"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":[0.0001848886,0.0002842374,0.0002925087,0.0008123011,0.0002033336,0.000002131065,0.00001104397,7.430069e-9,0.0001154456,0.01222499,0.000113369,0.9857557],"study_design_scores_gemma":[0.0006445633,0.0008921219,0.003185656,0.001708863,0.000173641,0.00001480206,0.00001024172,2.248095e-8,0.00005122016,0.000558838,0.9923657,0.0003943718],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0004756294,0.9944108,0.00001003626,0.00003139508,0.0002944984,0.0006409113,0.0002550508,0.00003752088,0.00384419],"genre_scores_gemma":[0.0006641088,0.9981441,0.0003262761,0.0001340434,0.00002839541,0.0000195736,0.0001221013,0.00001441364,0.0005469318],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9922523,"threshold_uncertainty_score":0.9999791,"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."}}