{"id":"W2978074964","doi":"10.4155/bio-2019-0207","title":"GCC Consolidated Feedback to ICH on the 2019 ICH M10 Bioanalytical Method Validation Draft Guideline","year":2019,"lang":"de","type":"article","venue":"Bioanalysis","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":29,"is_retracted":false,"has_abstract":true,"ca_institutions":"NEOMED Institute; Lambda Therapeutic Research; Pharma Medica Research (Canada); Grand Challenges Canada; Altasciences (Canada); Green Communities Canada; Royal Canadian Military Institute; Celerion (Canada)","funders":"","keywords":"Guideline; Bioanalysis; Attendance; Engineering; Political science; Nanotechnology; Law; Materials science","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":[0.0852546,0.002349316,0.001535712,0.006896813,0.003186608,0.006116841,0.00520451,0.009949914,0.01616955],"category_scores_gemma":[0.1164448,0.001230801,0.002186555,0.003544616,0.003510945,0.002806139,0.006474799,0.008147358,0.01837243],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.008663839,"about_ca_system_score_gemma":0.04952221,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.02552971,"about_ca_topic_score_gemma":0.03205864,"domain_scores_codex":[0.9219697,0.02791321,0.007432676,0.002168258,0.03733556,0.003180713],"domain_scores_gemma":[0.8122151,0.01839818,0.007237798,0.005997276,0.1518459,0.004305758],"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":[0.0003081759,0.0001117273,0.0009071996,0.001686319,0.00004582479,0.0004208314,0.0008231444,0.0004621379,0.005170737,0.003362802,0.9265182,0.06018286],"study_design_scores_gemma":[0.00005476767,0.0002156587,0.001482371,0.002261624,0.00006732088,0.0002778328,0.0006588518,0.0003087415,0.006199341,0.001882429,0.9865105,0.00008069196],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"commentary","genre_scores_codex":[0.02103914,0.05390627,0.1013487,0.3568654,0.08193178,0.01892213,0.0412284,0.008644036,0.3161142],"genre_scores_gemma":[0.08021917,0.04778907,0.2107728,0.2454065,0.01038995,0.01022083,0.08845024,0.006942396,0.299809],"genre_candidate":"commentary","genre_consensus":"commentary","teacher_disagreement_score":0.0852546,"threshold_uncertainty_score":0.4508748,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02036949132567383,"score_gpt":0.321898828142422,"score_spread":0.3015293368167482,"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."}}