{"id":"W3121304865","doi":"10.4155/bio-2021-0005","title":"2020 White Paper on Recent Issues in Bioanalysis: BAV Guidance, CLSI H62, Biotherapeutics Stability, Parallelism Testing, CyTOF and Regulatory Feedback ( <u>Part 2A</u> –Recommendations on Biotherapeutics Stability, PK LBA Regulated Bioanalysis, Biomarkers Assays, Cytometry Validation &amp; Innovation <u>Part 2B</u> –Regulatory Agencies’ Inputs on Bioanalysis, Biomarkers, Immunogenicity, Gene &amp; Cell Therapy and Vaccine)","year":2021,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":26,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Bioanalysis; Excellence; Biosimilar; Biopharmaceutical; Computer science; Regulatory science; Business; Biotechnology; Political science; Nanotechnology; Medicine; Biology","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":[0.02781235,0.001971259,0.001543528,0.003175515,0.003076781,0.01316016,0.005060774,0.01804322,0.06203736],"category_scores_gemma":[0.02696902,0.001328294,0.001748467,0.002213503,0.002960386,0.005780052,0.003738584,0.01029098,0.1027361],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.006287173,"about_ca_system_score_gemma":0.02297001,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.007566742,"about_ca_topic_score_gemma":0.01151164,"domain_scores_codex":[0.9790264,0.002636896,0.001308323,0.001532496,0.01395717,0.001538777],"domain_scores_gemma":[0.965679,0.006233274,0.002818101,0.001659564,0.01904428,0.004565814],"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":[0.00002814675,0.00003838999,0.00003555277,0.0001471182,0.00000317434,0.0000382451,0.00003505533,0.00007513979,0.0007577955,0.002161781,0.9780957,0.01858391],"study_design_scores_gemma":[0.000005812396,0.00002127372,0.00009605057,0.0001013938,0.000002179536,0.0000240987,0.00002307673,0.00004694704,0.00044151,0.000739014,0.9984901,0.000008535892],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"other","genre_gemma":"other","genre_scores_codex":[0.001260036,0.0325581,0.01783141,0.2580582,0.3157959,0.001794012,0.006011462,0.003705616,0.3629853],"genre_scores_gemma":[0.004350058,0.01386806,0.01332208,0.1297354,0.04468286,0.0009778899,0.005397314,0.002692804,0.7849736],"genre_candidate":"other","genre_consensus":"other","teacher_disagreement_score":0.06203736,"threshold_uncertainty_score":0.2075356,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0716324586553338,"score_gpt":0.3108688262131721,"score_spread":0.2392363675578383,"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."}}