{"id":"W2981766175","doi":"10.1016/j.biologicals.2019.10.008","title":"Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories & supporting data requirements","year":2019,"lang":"en","type":"review","venue":"Biologicals","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"World Health Organization","keywords":"Quality (philosophy); Product (mathematics); Business; Process management; Process (computing); Order (exchange); Operations management; Risk analysis (engineering); Computer science; Engineering; Finance","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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.034761,0.000633548,0.0008117681,0.0016756,0.0007983705,0.001645702,0.002075678,0.002642352,0.004668859],"category_scores_gemma":[0.03935774,0.0004493311,0.001183103,0.002439121,0.0009295851,0.001927747,0.001629306,0.001128057,0.0008828948],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003269545,"about_ca_system_score_gemma":0.005936737,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003739004,"about_ca_topic_score_gemma":0.006879763,"domain_scores_codex":[0.9708964,0.0188647,0.003411487,0.0007985567,0.005413084,0.000615903],"domain_scores_gemma":[0.9612843,0.02783041,0.003552958,0.001645355,0.00532427,0.0003627279],"domain_codex":null,"domain_gemma":"reporting","domain_candidate":"reporting","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"simulation_or_modeling","study_design_scores_codex":[0.001068945,0.001478076,0.009712009,0.06326558,0.0003449214,0.008259842,0.01194498,0.01211079,0.005265709,0.05056727,0.04951002,0.7864718],"study_design_scores_gemma":[0.0003968939,0.001728224,0.007498968,0.02252436,0.0005354167,0.007681495,0.008020822,0.003441517,0.01109611,0.007892341,0.9290531,0.000130706],"study_design_candidate":"simulation_or_modeling","study_design_consensus":null,"genre_codex":"review","genre_gemma":"methods","genre_scores_codex":[0.26046,0.4180368,0.09205175,0.03269299,0.002291601,0.04494799,0.006283233,0.000443299,0.1427923],"genre_scores_gemma":[0.6215953,0.2329664,0.1095118,0.004628111,0.000399996,0.01421012,0.002138399,0.00009282937,0.01445687],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.965239,"threshold_uncertainty_score":0.1838359,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.7420894449380853,"score_gpt":0.5846845918852744,"score_spread":0.1574048530528108,"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."}}