{"id":"W2465540401","doi":"10.1208/s12249-015-0338-5","title":"Acceptance Probability (P a) Analysis for Process Validation Lifecycle Stages","year":2015,"lang":"en","type":"article","venue":"AAPS PharmSciTech","topic":"Drug Solubulity and Delivery Systems","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":5,"is_retracted":false,"has_abstract":false,"ca_institutions":"Apotex (Canada)","funders":"","keywords":"Acceptance testing; Quality (philosophy); Computer science; Statistical process control; Process (computing); Product (mathematics); Process validation; Reliability engineering; Risk analysis (engineering); Statistics; Mathematics; Engineering; Verification and validation; Medicine","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"],"consensus_categories":[],"category_scores_codex":[0.002566499,0.0002643723,0.0004578847,0.00021913,0.0002648182,0.00007703983,0.0004654245,0.0003167949,0.0004718858],"category_scores_gemma":[0.0003964414,0.000256213,0.000243805,0.001174011,0.000160557,0.0004952914,0.00006660292,0.0003836155,0.0001399509],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0001445814,"about_ca_system_score_gemma":0.0001823448,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00003392978,"about_ca_topic_score_gemma":0.00003418124,"domain_scores_codex":[0.9975882,0.0004145788,0.0005271772,0.0006056561,0.0003379354,0.0005264378],"domain_scores_gemma":[0.9980301,0.0003485429,0.0002556089,0.0003781428,0.0005820754,0.0004055011],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"not_applicable","study_design_scores_codex":[0.002525878,0.002546288,0.8439415,0.0009594143,0.003830861,0.00002399959,0.008420245,0.0588059,0.008739328,0.002562647,0.03855944,0.02908453],"study_design_scores_gemma":[0.01275188,0.0008827572,0.01531223,0.00004582173,0.005393585,0.0000289344,0.002318624,0.09921782,0.3257088,0.03348855,0.5024722,0.002378827],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9834766,0.0004052212,0.008643674,0.0009158124,0.001239275,0.001591549,0.0002941605,0.000344723,0.00308901],"genre_scores_gemma":[0.9961586,0.00002364658,0.0006191643,0.0008001759,0.0003726762,0.0004755814,0.0001771608,0.00002467725,0.001348339],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.8286293,"threshold_uncertainty_score":0.999989,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2662302173242163,"score_gpt":0.4816220435326795,"score_spread":0.2153918262084632,"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."}}