{"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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001972933,0.0001945476,0.0002962677,0.0005025505,0.0002514227,0.0001508407,0.0002409831,0.0002265895,0.0000704],"category_scores_gemma":[0.0003640023,0.0001895619,0.00006518543,0.0004820243,0.0004389739,0.00001315252,0.0001561362,0.0007817837,4.592629e-7],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002172724,"about_ca_system_score_gemma":0.01188668,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.005204056,"about_ca_topic_score_gemma":0.0112151,"domain_scores_codex":[0.9976231,0.0004207943,0.0006453142,0.0003410445,0.0004053345,0.000564376],"domain_scores_gemma":[0.9979844,0.0001393768,0.0001366603,0.0001784229,0.001039521,0.0005215923],"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":[0.002298789,0.002268896,0.1837678,0.0037886,0.0009336819,0.0003652297,0.002889509,0.00005185395,0.5020839,0.005891521,0.07170088,0.2239594],"study_design_scores_gemma":[0.003512591,0.0009072295,0.2204609,0.0006323603,0.00008965804,0.0003489497,0.004811893,0.00007306119,0.2183641,0.0004906383,0.5498301,0.0004785371],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9776081,0.01679584,0.00001845548,0.003858835,0.0007969343,0.0005556656,0.00007660724,5.794184e-7,0.0002890198],"genre_scores_gemma":[0.9920014,0.00413718,0.0001435157,0.000717859,0.0004451667,0.00002302405,0.00001551909,0.00001476593,0.002501553],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.4781292,"threshold_uncertainty_score":0.993715,"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."}}