{"id":"W2981766175","doi":"10.1016/j.biologicals.2019.10.008","title":"Quality changes to approved biotherapeutic product: Simulated case studies on reporting categories &amp; 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":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.0087078,0.0008784526,0.004328649,0.000203964,0.0003422938,0.00005454199,0.0009768527,0.001121068,0.0002427888],"category_scores_gemma":[0.01784774,0.0004884202,0.0003767942,0.0005380013,0.0004056999,0.00004948141,0.001325803,0.0007833253,0.0004233769],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001212426,"about_ca_system_score_gemma":0.0001337652,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00004956696,"about_ca_topic_score_gemma":0.00005279718,"domain_scores_codex":[0.9910699,0.002356824,0.003361937,0.002185539,0.00009490494,0.0009309708],"domain_scores_gemma":[0.9909974,0.001953337,0.004229553,0.002517266,0.0002236652,0.0000787813],"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":[0.00009183346,0.0002669553,0.00004917193,0.00706651,0.00271378,0.0002105921,0.0001269345,6.160254e-7,0.002061877,0.0001708333,0.003052298,0.9841886],"study_design_scores_gemma":[0.0001820983,0.0003963733,0.00000495018,0.001728406,0.0008486828,0.0004616077,0.0001329876,5.096716e-7,0.0003198701,0.00007216753,0.9951104,0.0007419722],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0005952719,0.9934705,0.0000256936,0.0007160174,0.001712732,0.002460783,0.0006816925,0.0001943532,0.0001429075],"genre_scores_gemma":[0.0009106864,0.9899181,0.001314184,0.001469439,0.0002701562,0.00008930847,0.001675116,0.00006393601,0.004289126],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9920581,"threshold_uncertainty_score":0.9997568,"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."}}