{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","insufficient_payload"],"consensus_categories":["metaepi_narrow"],"category_scores_codex":[0.003039186,0.001286304,0.001917389,0.004628325,0.0008312839,0.0003127971,0.0004889145,0.0008400314,0.0009256137],"category_scores_gemma":[0.0002958743,0.001222153,0.0008006884,0.007394592,0.0004993161,0.0004504554,0.0002731979,0.0009863116,0.00002693291],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001049108,"about_ca_system_score_gemma":0.0003550863,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00165877,"about_ca_topic_score_gemma":0.001859111,"domain_scores_codex":[0.9911186,0.001739761,0.002704362,0.002436117,0.0008779817,0.001123179],"domain_scores_gemma":[0.9953054,0.0008766247,0.001258367,0.00136015,0.0006317595,0.0005677582],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.005974697,0.007369122,0.01767404,0.0008803134,0.06821007,0.0001073419,0.004017903,0.004036262,0.7943747,0.000911609,0.004157335,0.0922866],"study_design_scores_gemma":[0.01692401,0.002667069,0.05689662,0.001781888,0.02253264,0.00008836327,0.003143723,0.1421734,0.5167751,0.002216821,0.227158,0.007642434],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9447328,0.04649937,0.0004274752,0.004305776,0.0004401172,0.001703438,0.001273077,0.0002948929,0.0003230408],"genre_scores_gemma":[0.8824832,0.1010793,0.009805829,0.0004547312,0.000196447,0.0002335827,0.00474416,0.000152565,0.0008501249],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.2775997,"threshold_uncertainty_score":0.9999889,"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."}}