{"id":"W2802249086","doi":"10.4155/bio-2018-0014","title":"11th GCC Closed Forum: Cumulative Stability; Matrix Stability; Immunogenicity assays; Laboratory Manuals; Biosimilars; Chiral methods; Hybrid LBA/LCMS Assays; Fit-for-Purpose Validation; China Food and Drug Administration Bioanalytical Method Validation","year":2018,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":15,"is_retracted":false,"has_abstract":true,"ca_institutions":"Pharma Medica Research (Canada); inVentiv Health Clinical; Grand Challenges Canada","funders":"","keywords":"Bioanalysis; Immunogenicity; Biosimilar; Food and drug administration; Medical education; Computer science; Chemistry; Medicine; Pharmacology; Chromatography; Internal medicine","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":[0.009252373,0.0009962115,0.001793438,0.0006620761,0.001029517,0.0002845117,0.0007094798,0.0008420404,0.001425964],"category_scores_gemma":[0.002541578,0.0008556334,0.0009736326,0.001733658,0.001566216,0.0006027081,0.0003910334,0.0007587931,0.00004738077],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0003604879,"about_ca_system_score_gemma":0.0003787277,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00009018932,"about_ca_topic_score_gemma":0.0001506408,"domain_scores_codex":[0.9887879,0.005540799,0.002024869,0.002050336,0.0003722637,0.001223803],"domain_scores_gemma":[0.9937224,0.002425497,0.0009538169,0.001537878,0.001078943,0.0002814609],"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":[0.008414765,0.005413083,0.03423416,0.0009633095,0.02373298,0.00002347479,0.00301133,0.00003554157,0.7764447,0.02253606,0.006309535,0.1188811],"study_design_scores_gemma":[0.00245259,0.001695637,0.003185455,0.00004204623,0.003749813,0.00002646073,0.0008667135,0.003091613,0.9635134,0.008123748,0.01207014,0.001182331],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.6603299,0.007596866,0.3062896,0.01193001,0.001417086,0.003873504,0.007101682,0.0005894825,0.0008718491],"genre_scores_gemma":[0.8528113,0.000149489,0.1450905,0.0003742119,0.0001636973,0.0001295725,0.0007934102,0.00007784718,0.0004100222],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.1924813,"threshold_uncertainty_score":0.9994869,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03864693967655648,"score_gpt":0.3664458933095864,"score_spread":0.32779895363303,"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."}}