{"id":"W4385442519","doi":"10.4155/bio-2023-0135","title":"2022 White Paper on Recent Issues in Bioanalysis: Fda Draft Guidance on Immunogenicity Information in Prescription Drug Labeling, Lnp & Viral Vectors Therapeutics/Vaccines Immunogenicity, Prolongation Effect, Ada Affinity, Risk-Based Approaches, Ngs, Qpcr, Ddpcr Assays ( Part 3 – Recommendations on Gene Therapy, Cell Therapy, Vaccines Immunogenicity & Technologies; Immunogenicity & Risk Assessment of Biotherapeutics and Novel Modalities; NAb Assays Integrated Approach)","year":2023,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":16,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Excellence; Bioanalysis; Regulatory science; Medicine; Computer science; Political science; Nanotechnology","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":[],"consensus_categories":[],"category_scores_codex":[0.02062735,0.001734647,0.001348364,0.002506137,0.003078627,0.009923302,0.005557457,0.02613511,0.02872188],"category_scores_gemma":[0.02087851,0.001469217,0.001966002,0.001998405,0.003059451,0.00373043,0.002454188,0.01043395,0.04335293],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00520334,"about_ca_system_score_gemma":0.02326305,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.02166644,"about_ca_topic_score_gemma":0.03592151,"domain_scores_codex":[0.9827765,0.00258842,0.001587939,0.001318019,0.0104398,0.001289346],"domain_scores_gemma":[0.9688557,0.008668819,0.002455382,0.00110179,0.01661733,0.002301095],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00003280445,0.00006517203,0.00008724126,0.0001493754,0.000006166983,0.0001061935,0.00007092041,0.00008939968,0.00100011,0.002078834,0.976266,0.0200478],"study_design_scores_gemma":[0.00001224325,0.0000277871,0.0003225862,0.0002170967,0.000006822248,0.00006061642,0.00003566124,0.00006669492,0.0005623235,0.0007634442,0.9979094,0.000015244],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.002663913,0.035893,0.01620871,0.3794132,0.1393683,0.002370931,0.008693571,0.002188234,0.4132002],"genre_scores_gemma":[0.00910484,0.01794793,0.01532269,0.3398123,0.02971386,0.001079684,0.006263328,0.001329363,0.5794259],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.02872188,"threshold_uncertainty_score":0.1090891,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04790826792381044,"score_gpt":0.3012674909984366,"score_spread":0.2533592230746262,"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."}}