{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","insufficient_payload"],"consensus_categories":[],"category_scores_codex":[0.005363924,0.000782545,0.001768263,0.0009475976,0.0004168228,0.000094937,0.0007971172,0.001245655,0.001428177],"category_scores_gemma":[0.001167578,0.0005479874,0.000667572,0.002211958,0.001378067,0.0003054495,0.0003657228,0.000559566,0.00002579464],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002704499,"about_ca_system_score_gemma":0.0004826255,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0002206432,"about_ca_topic_score_gemma":0.0006167229,"domain_scores_codex":[0.9899998,0.004414157,0.001832172,0.002006794,0.0003031495,0.001443947],"domain_scores_gemma":[0.995222,0.001907038,0.0007216423,0.001501385,0.0004303556,0.0002175195],"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":[0.000768684,0.001149038,0.03723102,0.00008988327,0.008755351,0.00004766131,0.0008265131,0.00001796916,0.8712206,0.0006011758,0.0009676169,0.07832442],"study_design_scores_gemma":[0.005619601,0.0007116,0.004631739,0.0001568655,0.005761991,0.00008714456,0.002745994,0.000607879,0.9504858,0.001402384,0.02605212,0.001736853],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8385903,0.07290155,0.06560277,0.01673512,0.001331039,0.002489532,0.001069091,0.0007234174,0.0005571957],"genre_scores_gemma":[0.9617521,0.001141937,0.03535037,0.0004658083,0.00007660847,0.000173077,0.0001040857,0.00007702298,0.0008589907],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1231618,"threshold_uncertainty_score":0.9996971,"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."}}