{"id":"W4409908693","doi":"10.5731/pdajpst.2024-003023.1","title":"Worldwide Regulatory Reliance: Results of an Executed Chemistry, Manufacturing and Control Post Approval Change Pilot","year":2025,"lang":"en","type":"article","venue":"PDA Journal of Pharmaceutical Science and Technology","topic":"Chemistry and Chemical Engineering","field":"Environmental Science","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"Sanofi (Canada)","funders":"","keywords":"Control (management); Business; Computer science; Risk analysis (engineering); Chemistry","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":[0.03376831,0.0008095966,0.0005359494,0.001829644,0.002446321,0.003046457,0.001442209,0.002202894,0.005763142],"category_scores_gemma":[0.06595156,0.0005536737,0.0009038976,0.001779812,0.002680507,0.002576828,0.00287685,0.002901357,0.002534389],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003230271,"about_ca_system_score_gemma":0.005857928,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.009124413,"about_ca_topic_score_gemma":0.008385035,"domain_scores_codex":[0.9753416,0.01261199,0.0009920107,0.001723478,0.007741131,0.00158979],"domain_scores_gemma":[0.9216012,0.03421981,0.006783507,0.009709636,0.02360628,0.004079581],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"observational","study_design_scores_codex":[0.01284403,0.06276374,0.161051,0.0018949,0.0006691796,0.005937981,0.03078963,0.01558087,0.02960019,0.009594202,0.03612532,0.6331489],"study_design_scores_gemma":[0.004207275,0.1777284,0.4922539,0.0008915397,0.0008967422,0.004812573,0.04073112,0.01936055,0.05224157,0.007779045,0.1983877,0.0007095824],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9506754,0.0003964749,0.007342215,0.001964601,0.0001592847,0.003104814,0.001049903,0.0005512846,0.03475586],"genre_scores_gemma":[0.9777601,0.0004948764,0.009344574,0.001437475,0.0000824509,0.001151994,0.00160224,0.0002293109,0.007897041],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.03376831,"threshold_uncertainty_score":0.178586,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.01027633469985809,"score_gpt":0.2630047654323048,"score_spread":0.2527284307324467,"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."}}