{"id":"W4399096973","doi":"10.1080/17576180.2024.2347153","title":"2023 White Paper on Recent Issues in Bioanalysis: Deuterated Drugs; LNP; Tumor/FFPE Biopsy; Targeted Proteomics; Small Molecule Covalent Inhibitors; Chiral Bioanalysis; Remote Regulatory Assessments; Sample Reconciliation/Chain of Custody (PART 1A – Recommendations on Mass Spectrometry, Chromatography, Sample Preparation Latest Developments, Challenges, and Solutions and BMV/Regulated Bioanalysis PART 1B - Regulatory Agencies' Inputs on Regulated Bioanalysis/BMV, Biomarkers/IVD/CDx/BAV, Immunogenicity, Gene & Cell Therapy and Vaccine)","year":2024,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Chemical Reactions and Isotopes","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":11,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada; Micropharma (Canada)","funders":"U.S. Food and Drug Administration; Ministry of Health, Labour and Welfare; Seagen; Exelixis; World Health Organization; Health Canada; Spark Therapeutics; Genentech; AstraZeneca","keywords":"Bioanalysis; Chemistry; Computational biology; Small molecule; Nanotechnology; Pharmacology; Chromatography; Medicine; Biology; Biochemistry; Materials science","routes":{"ca_aff":true,"ca_fund":true,"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":[0.009260245,0.001084278,0.0007411212,0.001616331,0.002059978,0.006808199,0.002653067,0.01221389,0.03833828],"category_scores_gemma":[0.009471915,0.0007929164,0.0009785201,0.001533253,0.002578302,0.003390428,0.00199587,0.007963618,0.03984214],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003338527,"about_ca_system_score_gemma":0.007589101,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.005067177,"about_ca_topic_score_gemma":0.01271418,"domain_scores_codex":[0.993894,0.001040936,0.0005448413,0.000765235,0.00326473,0.0004901728],"domain_scores_gemma":[0.9858435,0.003750335,0.001416225,0.0006289658,0.006587361,0.001773684],"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":[0.00004012466,0.00003728719,0.00008883075,0.0001738699,0.000004434008,0.0001642709,0.00004532632,0.00004668247,0.001421766,0.001909475,0.9533104,0.04275746],"study_design_scores_gemma":[0.0000057807,0.00001547059,0.0001819875,0.0001404958,0.00000299073,0.000127212,0.00002641714,0.00004204961,0.0007128871,0.0006235795,0.9981142,0.000006903162],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.002084335,0.06181956,0.01096812,0.3522206,0.2730429,0.0009574707,0.002373855,0.00109584,0.2954374],"genre_scores_gemma":[0.008515855,0.03564192,0.009223654,0.1912764,0.07737774,0.0005114351,0.003079904,0.001069219,0.6733038],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.03833828,"threshold_uncertainty_score":0.1282543,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0717066412561985,"score_gpt":0.3438804714840708,"score_spread":0.2721738302278723,"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."}}