{"id":"W2280270666","doi":"10.4155/bio.16.16","title":"9th GCC Closed Forum: Capa in Regulated Bioanalysis; Method Robustness, Biosimilars, Preclinical Method Validation, Endogenous Biomarkers, Whole Blood Stability, Regulatory Audit Experiences and Electronic Laboratory Notebooks","year":2016,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":16,"is_retracted":false,"has_abstract":true,"ca_institutions":"inVentiv Health Clinical; BioPhage Pharma (Canada); Caprion (Canada)","funders":"","keywords":"Bioanalysis; Biosimilar; Audit; Attendance; Medicine; Pharmacology; Political science; Business; Chemistry; Internal medicine; Accounting; 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":[],"consensus_categories":[],"category_scores_codex":[0.03147074,0.001358154,0.0006339629,0.001943553,0.007872955,0.01177621,0.002805544,0.01516772,0.05560757],"category_scores_gemma":[0.02550339,0.0006546477,0.0008941717,0.001285169,0.004607337,0.004477034,0.0086526,0.00837589,0.01532038],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.006666683,"about_ca_system_score_gemma":0.01048064,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01005885,"about_ca_topic_score_gemma":0.01850282,"domain_scores_codex":[0.9879342,0.005543386,0.0004921525,0.001029935,0.003526848,0.00147342],"domain_scores_gemma":[0.9581507,0.01590183,0.002865361,0.002306856,0.01277665,0.007998528],"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":[0.0002615488,0.0001937937,0.001124265,0.0002868379,0.000009047064,0.001107616,0.002725527,0.0002974627,0.003853272,0.009476762,0.9285874,0.05207643],"study_design_scores_gemma":[0.00001520872,0.00008303841,0.001766246,0.0002988489,0.000003813706,0.0002773975,0.001227323,0.0001736189,0.000997944,0.001755198,0.9933717,0.00002963442],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.04606761,0.03479624,0.03595213,0.4048436,0.0980421,0.002451244,0.003028099,0.002626856,0.3721921],"genre_scores_gemma":[0.1335918,0.005113385,0.02943622,0.0649159,0.02238913,0.001148389,0.002645243,0.002526861,0.738233],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.05560757,"threshold_uncertainty_score":0.1860259,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0286170192861964,"score_gpt":0.2961344516991059,"score_spread":0.2675174324129095,"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."}}