{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.01467581,0.002044915,0.001177032,0.003085482,0.002482227,0.00828811,0.003731679,0.014505,0.1040898],"category_scores_gemma":[0.01755511,0.00141437,0.00154565,0.002242934,0.001824996,0.004716455,0.003361981,0.00854429,0.148653],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004824423,"about_ca_system_score_gemma":0.01373173,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01104325,"about_ca_topic_score_gemma":0.01909485,"domain_scores_codex":[0.9865996,0.00196385,0.001086807,0.0011613,0.008122653,0.001065782],"domain_scores_gemma":[0.9758203,0.004052886,0.002280979,0.0009452644,0.01383462,0.003066031],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0000253412,0.00005056119,0.00005894967,0.0002648275,0.000003004473,0.00005886046,0.00005607422,0.00008911165,0.001053682,0.001436439,0.9594227,0.03748044],"study_design_scores_gemma":[0.000003884029,0.00001554615,0.0001725378,0.0001705871,0.000002275352,0.00002839863,0.00002494158,0.00002720624,0.0003610522,0.000366643,0.9988181,0.000008819535],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"methods","genre_scores_codex":[0.00170689,0.04926851,0.01617643,0.2141067,0.1909046,0.002151319,0.008403463,0.003364427,0.5139177],"genre_scores_gemma":[0.0033237,0.02273218,0.009890269,0.07384428,0.02097018,0.0007893245,0.007832376,0.001688364,0.8589293],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.9853242,"threshold_uncertainty_score":0.348215,"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."}}