{"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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.0005765963,0.0001050215,0.000189646,0.00008015676,0.00008489162,0.00001664311,0.000354171,0.00007593456,0.00003688426],"category_scores_gemma":[0.0002673215,0.00008810469,0.0000185144,0.0004785006,0.001444521,0.0002398065,0.0001970288,0.0003258898,5.323707e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.00007178979,"about_ca_system_score_gemma":0.00002880514,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000008004839,"about_ca_topic_score_gemma":6.650729e-7,"domain_scores_codex":[0.9989252,0.000006976446,0.0003029929,0.00023529,0.0002716519,0.0002578982],"domain_scores_gemma":[0.9994713,0.00004863241,0.0001205842,0.0001406162,0.00004910276,0.0001697812],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"bench_or_experimental","study_design_scores_codex":[0.0001384348,0.00005429252,0.0002970133,0.00003672162,0.000007044164,0.00001186871,0.00001621145,0.000008851513,0.9339918,0.00003710645,0.00002087891,0.06537971],"study_design_scores_gemma":[0.001243663,0.00008483309,0.002027884,0.00005735457,0.00002576617,0.0001176431,0.00005113864,0.0010552,0.9904266,0.0004281092,0.004392575,0.00008924511],"study_design_candidate":"bench_or_experimental","study_design_consensus":"bench_or_experimental","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9961547,0.0003729981,0.00009302601,0.002433127,0.00004777077,0.00006743679,0.00000440133,0.00001968158,0.0008069021],"genre_scores_gemma":[0.9990512,0.0001125943,0.000615854,0.0001521409,0.00002750475,0.000002534739,2.932596e-7,0.000003294628,0.0000346371],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.06529047,"threshold_uncertainty_score":0.5322397,"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."}}