{"id":"W4383620165","doi":"10.1208/s12248-023-00830-5","title":"Neutralizing Antibody Validation Testing and Reporting Harmonization","year":2023,"lang":"en","type":"article","venue":"The AAPS Journal","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":26,"is_retracted":false,"has_abstract":true,"ca_institutions":"Pfizer (Canada); TransCanada (Canada)","funders":"Strong","keywords":"Harmonization; Immunogenicity; Food and drug administration; Computer science; Robustness (evolution); Medicine; Risk analysis (engineering); Antibody; Chemistry; Immunology","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":[],"consensus_categories":[],"category_scores_codex":[0.002353203,0.00006642071,0.0001192753,0.00005990439,0.0005180363,0.00006800772,0.00008192722,0.00007185466,0.00005483995],"category_scores_gemma":[0.001937118,0.00003942848,0.00003448613,0.0003018932,0.00008128974,0.000075139,0.00005468093,0.0003008914,0.00002579809],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.000008483385,"about_ca_system_score_gemma":0.00001719182,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000007768793,"about_ca_topic_score_gemma":2.942267e-7,"domain_scores_codex":[0.9990367,0.0002210435,0.0004217483,0.00009723569,0.00002980401,0.0001935229],"domain_scores_gemma":[0.9990693,0.0002891984,0.000463681,0.00008375297,0.00007727808,0.00001677524],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"observational","study_design_scores_codex":[0.00001175283,0.000008245891,0.03326816,0.000007250559,0.00004936043,0.00001863424,0.000169514,0.00002378844,0.9319596,0.0002236854,0.001503651,0.0327564],"study_design_scores_gemma":[0.00127423,0.0002928252,0.5681794,0.0002774963,0.0003360033,0.00766737,0.0011301,0.002059176,0.3866209,0.01631826,0.01537352,0.0004707885],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9923754,0.0005417465,0.002166762,0.003509189,0.0005421638,0.00006972783,0.000001490499,0.0000745683,0.0007189168],"genre_scores_gemma":[0.9972134,0.0001675252,0.001642935,0.0001938304,0.0001187741,7.328934e-7,0.000006507345,0.000008589842,0.0006477142],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5453387,"threshold_uncertainty_score":0.3984369,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1436484235687656,"score_gpt":0.3814750163648544,"score_spread":0.2378265927960888,"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."}}