{"id":"W2050903060","doi":"10.4155/bio.11.192","title":"2011 White Paper on Recent Issues in Bioanalysis and Regulatory Findings from Audits and Inspections","year":2011,"lang":"en","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":93,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada; BioPhage Pharma (Canada)","funders":"U.S. Food and Drug Administration","keywords":"Bioanalysis; Excellence; White paper; Audit; Engineering ethics; Computer science; Political science; Nanotechnology; Business; Engineering; Accounting","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":[0.04527603,0.0008914061,0.0006366692,0.004155565,0.005116687,0.01475143,0.002526661,0.01255852,0.009602334],"category_scores_gemma":[0.07781341,0.0009561772,0.001245711,0.005701962,0.003427986,0.007193394,0.003313851,0.008782275,0.004703472],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.006208599,"about_ca_system_score_gemma":0.02506274,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01211035,"about_ca_topic_score_gemma":0.01841066,"domain_scores_codex":[0.9635261,0.006968851,0.003675842,0.00240911,0.02149326,0.001926797],"domain_scores_gemma":[0.9095735,0.03558179,0.009043189,0.004325963,0.03845608,0.003019534],"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":[0.00004596378,0.00007015996,0.00086786,0.0004203923,0.00001246959,0.0004011836,0.001587966,0.0001767952,0.0006854429,0.008080975,0.9246935,0.06295722],"study_design_scores_gemma":[0.000004679244,0.00002964305,0.002285752,0.0006817649,0.00001469378,0.0001801053,0.00125043,0.0001038114,0.0007778781,0.001666608,0.9929716,0.00003298386],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.00738936,0.02633772,0.006583788,0.8229411,0.06106207,0.0003280696,0.0009705194,0.0004971758,0.07389027],"genre_scores_gemma":[0.09187238,0.07293825,0.0201289,0.4250353,0.04153418,0.0006144571,0.004616663,0.001259819,0.3420001],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.04527603,"threshold_uncertainty_score":0.2394454,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.03089835570510437,"score_gpt":0.2620523035579235,"score_spread":0.2311539478528191,"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."}}