{"id":"W4280536753","doi":"10.4155/bio-2022-0080","title":"2021 White Paper on Recent Issues in Bioanalysis: ISR for Biomarkers, Liquid Biopsies, Spectral Cytometry, Inhalation/Oral & Multispecific Biotherapeutics, Accuracy/LLOQ for Flow Cytometry ( Part 2 – Recommendations on Biomarkers/CDx Assays Development & Validation, Cytometry Validation & Innovation, Biotherapeutics PK LBA Regulated Bioanalysis, Critical Reagents & Positive Controls Generation)","year":2022,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosensors and Analytical Detection","field":"Engineering","cited_by":25,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Bioanalysis; Context (archaeology); Medical physics; Mass cytometry; Medicine; Biomarker; Chemistry; Biology; Chromatography","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":["metaepi_narrow","sts","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.003380352,0.001193484,0.001540237,0.007967526,0.00144945,0.0007340378,0.0006342111,0.0006672223,0.003315785],"category_scores_gemma":[0.001757449,0.001269354,0.0008664384,0.0167771,0.0002501605,0.0006719552,0.0001307439,0.0006658994,0.0001560195],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002632915,"about_ca_system_score_gemma":0.0002049793,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0001163882,"about_ca_topic_score_gemma":0.0009094989,"domain_scores_codex":[0.991064,0.0009415234,0.003282368,0.001889242,0.00155834,0.001264574],"domain_scores_gemma":[0.9942474,0.001293762,0.0008454167,0.001432691,0.001844189,0.0003365411],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"not_applicable","study_design_scores_codex":[0.007708271,0.009547253,0.01241053,0.001118107,0.05962572,0.00001905488,0.003228979,0.116551,0.4941445,0.00259787,0.0447735,0.2482752],"study_design_scores_gemma":[0.004602695,0.0005467875,0.002400375,0.0003010852,0.003023358,0.00001385242,0.0005672792,0.08277491,0.05130866,0.0003207926,0.851196,0.002944245],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.1605228,0.00806936,0.7732929,0.0340414,0.004776539,0.006860144,0.01052452,0.001373837,0.0005385211],"genre_scores_gemma":[0.7977192,0.005200506,0.1277252,0.001847424,0.001297003,0.00136366,0.06224587,0.0004668495,0.002134331],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.8064225,"threshold_uncertainty_score":0.9998505,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.05995653969596512,"score_gpt":0.3272192253073786,"score_spread":0.2672626856114134,"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."}}