{"id":"W3215384357","doi":"10.1208/s12248-021-00649-y","title":"Anti-drug Antibody Validation Testing and Reporting Harmonization","year":2021,"lang":"en","type":"article","venue":"The AAPS Journal","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":72,"is_retracted":false,"has_abstract":true,"ca_institutions":"Pfizer (Canada); TransCanada (Canada)","funders":"","keywords":"Harmonization; Immunogenicity; Sample (material); Biotechnology; Computer science; Medicine; Chemistry; Biology; Chromatography; Antibody; 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":[0.001651969,0.00007239462,0.0001603495,0.00002703101,0.0004562178,0.0000823907,0.00007124977,0.00006548397,0.0001811471],"category_scores_gemma":[0.002883544,0.00004412595,0.00004157638,0.000176963,0.00008911805,0.00007541598,0.00006451033,0.0003514312,0.000009104226],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00000967685,"about_ca_system_score_gemma":0.00004725117,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000005554029,"about_ca_topic_score_gemma":5.505599e-7,"domain_scores_codex":[0.9988736,0.0003505181,0.0004600484,0.0001192117,0.00003363912,0.0001629819],"domain_scores_gemma":[0.9989005,0.0002481757,0.0005232055,0.0001121504,0.0001974663,0.00001853101],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.000006608933,0.00002322161,0.04553179,0.000006517685,0.0000613752,0.00004191989,0.0001065855,0.00000667216,0.933384,0.0001425831,0.0009286328,0.0197601],"study_design_scores_gemma":[0.0006344608,0.00005244322,0.1620729,0.0001283556,0.0002064447,0.01159445,0.0004698567,0.0002175626,0.8122915,0.004060199,0.008067459,0.0002043747],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9862669,0.003056308,0.004709573,0.004246527,0.0005614479,0.00004729123,0.00000204256,0.0000229598,0.001086913],"genre_scores_gemma":[0.9926263,0.0002411807,0.005632838,0.0003461897,0.0001204579,3.481833e-7,0.000007280969,0.000007298372,0.001018109],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1210925,"threshold_uncertainty_score":0.3508905,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.07843213960607921,"score_gpt":0.3504298733020686,"score_spread":0.2719977336959894,"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."}}