{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.4404192,0.001729344,0.002271321,0.01240079,0.003109935,0.009633844,0.009598593,0.003308919,0.005759952],"category_scores_gemma":[0.3298664,0.001384284,0.002954812,0.006621597,0.004228448,0.005450523,0.006624295,0.005465494,0.006164959],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005602383,"about_ca_system_score_gemma":0.01959249,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004366281,"about_ca_topic_score_gemma":0.002195301,"domain_scores_codex":[0.5246758,0.2415905,0.07325327,0.01523163,0.1387417,0.006507067],"domain_scores_gemma":[0.4522069,0.07706679,0.03182899,0.1225805,0.3132225,0.003094188],"domain_codex":null,"domain_gemma":"reporting","domain_candidate":"reporting","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.001479879,0.001266709,0.03032639,0.004050842,0.0006470075,0.0007114722,0.006548082,0.005358112,0.04497635,0.03490824,0.1802084,0.6895185],"study_design_scores_gemma":[0.0004282134,0.002137558,0.02719309,0.004028565,0.0005181833,0.001423967,0.002786644,0.01725229,0.1540685,0.0173619,0.772422,0.0003792061],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.05885656,0.005635671,0.7398472,0.02033964,0.005007283,0.04148935,0.008283319,0.01392398,0.1066168],"genre_scores_gemma":[0.2473861,0.004483172,0.6470795,0.01116817,0.001740814,0.02866226,0.02675726,0.004211104,0.02851166],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.5595808,"threshold_uncertainty_score":0.6900627,"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."}}