{"id":"W4417151183","doi":"10.5530/ijper.20260762","title":"Regulatory Pathway for Genotoxic Impurities in Europe, US, Canada, India, Australia and UK","year":2025,"lang":"","type":"article","venue":"Indian Journal of Pharmaceutical Education and Research","topic":"Carcinogens and Genotoxicity Assessment","field":"Biochemistry, Genetics and Molecular Biology","cited_by":0,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"","keywords":"Genotoxicity; Impurity; Gene","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001175558,0.0003217315,0.0001792447,0.002058979,0.001050881,0.0022537,0.0005817583,0.0005338195,0.00750873],"category_scores_gemma":[0.001640071,0.0001702994,0.0004391094,0.001746313,0.0005640954,0.0004493002,0.0005061103,0.0007347682,0.0009874828],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00761105,"about_ca_system_score_gemma":0.01559582,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.3643039,"about_ca_topic_score_gemma":0.3268489,"domain_scores_codex":[0.9991622,0.00009608664,0.0000617737,0.0001190629,0.000403528,0.0001573567],"domain_scores_gemma":[0.9978511,0.0001991752,0.0002581213,0.00005638197,0.001465159,0.0001700211],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.001386418,0.0004510303,0.0725968,0.002813254,0.0001895099,0.002292199,0.002686431,0.005441043,0.1932425,0.1421155,0.06253587,0.5142494],"study_design_scores_gemma":[0.00004900689,0.0005933921,0.1690832,0.001036397,0.0002415924,0.001177549,0.003755092,0.002318685,0.1056131,0.005692116,0.7103306,0.000109142],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"review","genre_scores_codex":[0.4594658,0.04322988,0.01786492,0.01788355,0.000991298,0.001226704,0.01257598,0.001212003,0.44555],"genre_scores_gemma":[0.8360431,0.02271862,0.01514424,0.003183424,0.00005819973,0.0001976975,0.004135036,0.0001517651,0.1183679],"genre_candidate":"review","genre_consensus":null,"teacher_disagreement_score":0.6356962,"threshold_uncertainty_score":0.7243668,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04232715109641166,"score_gpt":0.424574585440542,"score_spread":0.3822474343441303,"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."}}