{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow","research_integrity","insufficient_payload"],"consensus_categories":["insufficient_payload"],"category_scores_codex":[0.005509275,0.001084831,0.002070348,0.0009117824,0.0005064507,0.0002946198,0.001547077,0.001616471,0.03213286],"category_scores_gemma":[0.001551864,0.0007110346,0.001383485,0.003236254,0.0006188715,0.0001216845,0.0006276158,0.00144537,0.03169617],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002795195,"about_ca_system_score_gemma":0.0002759113,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0004037775,"about_ca_topic_score_gemma":0.00003940836,"domain_scores_codex":[0.9900458,0.003708953,0.00222769,0.002006405,0.0004803446,0.001530788],"domain_scores_gemma":[0.9927662,0.002721156,0.0006647881,0.002624211,0.0008646635,0.0003589904],"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":[0.003171281,0.003020373,0.005100369,0.0001517889,0.03551686,0.00006398109,0.0005105942,0.0005267189,0.1761319,0.0231754,0.6970634,0.05556731],"study_design_scores_gemma":[0.001645281,0.0009823518,0.001175466,0.0001519977,0.008293572,0.00001710481,0.0004335859,0.003740238,0.1045063,0.0004523816,0.8772665,0.001335229],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"empirical","genre_scores_codex":[0.07789946,0.06975008,0.08366418,0.6784176,0.02298365,0.01131139,0.007706653,0.001087937,0.04717911],"genre_scores_gemma":[0.5792427,0.004806948,0.072282,0.08493954,0.002703546,0.0001446118,0.003872415,0.0005056395,0.2515026],"genre_candidate":"commentary","genre_consensus":null,"teacher_disagreement_score":0.593478,"threshold_uncertainty_score":0.9996796,"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."}}