{"id":"W2035140756","doi":"10.1208/s12248-012-9347-4","title":"Nonclinical Dose Formulation: Out of Specification Investigations","year":2012,"lang":"en","type":"article","venue":"The AAPS Journal","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":4,"is_retracted":false,"has_abstract":true,"ca_institutions":"Canadian Nuclear Laboratories","funders":"","keywords":"Good laboratory practice; Medicine; Risk analysis (engineering); Medical physics; Computer science; Quality assurance; External quality assessment","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":[],"consensus_categories":[],"category_scores_codex":[0.0012713,0.0000619314,0.0001292571,0.00003299462,0.0001836409,0.000009437601,0.0001683028,0.0001160433,0.0008919902],"category_scores_gemma":[0.000277461,0.00003421197,0.00009700003,0.00008051697,0.0002239772,0.0001019275,0.00003383095,0.0003551449,0.0001302998],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00001388756,"about_ca_system_score_gemma":0.0000290694,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000001181117,"about_ca_topic_score_gemma":9.831986e-7,"domain_scores_codex":[0.9991053,0.0002773696,0.0003514397,0.00005215286,0.00003851263,0.0001751674],"domain_scores_gemma":[0.9992285,0.0002875219,0.0001969405,0.000169252,0.00007951435,0.00003831605],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0003934997,0.0008483686,0.07020629,0.0000210925,0.0006670952,0.000001314893,0.003699138,0.00001065778,0.6510412,0.1238296,0.06958708,0.07969467],"study_design_scores_gemma":[0.001789138,0.0002976554,0.3821831,0.00005852519,0.0003627013,0.0004067055,0.0004974984,0.00004324484,0.1300151,0.02786422,0.4562078,0.000274305],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8739242,0.01175487,0.03158306,0.04485094,0.009518467,0.0005804421,0.00004508373,0.00007106758,0.02767188],"genre_scores_gemma":[0.9948946,0.00009920189,0.003246512,0.0003533656,0.0003496677,0.000001152259,0.000004060476,0.000004582127,0.001046894],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5210261,"threshold_uncertainty_score":0.9766667,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1279997089106289,"score_gpt":0.3693151611841914,"score_spread":0.2413154522735625,"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."}}