{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.4831087,0.00135279,0.002067142,0.01186343,0.002236178,0.01052677,0.009689936,0.003222467,0.003362905],"category_scores_gemma":[0.2825274,0.001203388,0.002859511,0.006987168,0.004094427,0.005772521,0.006685441,0.004813906,0.002998968],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00620516,"about_ca_system_score_gemma":0.01957271,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.002852772,"about_ca_topic_score_gemma":0.001815869,"domain_scores_codex":[0.4753817,0.3252608,0.06422959,0.01309679,0.1159106,0.006120535],"domain_scores_gemma":[0.5062257,0.09642733,0.04477402,0.1022973,0.2467901,0.003485609],"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":[0.001350178,0.001279161,0.02895804,0.005321804,0.0007563455,0.000466328,0.00687963,0.005350784,0.03141178,0.04674939,0.09404748,0.7774291],"study_design_scores_gemma":[0.0005295707,0.003618949,0.04597398,0.00521312,0.0005972014,0.00129403,0.003972394,0.01604027,0.1208191,0.02506479,0.7765387,0.000337782],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.07118336,0.01462121,0.7363847,0.03697634,0.003799885,0.03298333,0.005086457,0.007023596,0.09194113],"genre_scores_gemma":[0.3597914,0.008147039,0.5616032,0.01611047,0.001713121,0.0193659,0.01374364,0.001988431,0.01753671],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.5168914,"threshold_uncertainty_score":0.637419,"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."}}