{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.01475113,0.001261543,0.001160695,0.003874301,0.001196722,0.003528156,0.001949806,0.002130625,0.006768969],"category_scores_gemma":[0.06186539,0.0007133873,0.003399115,0.001822936,0.001367941,0.003251581,0.001704031,0.002797416,0.001184592],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001506518,"about_ca_system_score_gemma":0.003569898,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004980537,"about_ca_topic_score_gemma":0.002886166,"domain_scores_codex":[0.9869089,0.003277291,0.0007771378,0.0018879,0.005841633,0.001307123],"domain_scores_gemma":[0.8478505,0.1262975,0.006235057,0.004915492,0.01355843,0.001143098],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"simulation_or_modeling","study_design_gemma":"simulation_or_modeling","study_design_scores_codex":[0.003468113,0.0009256467,0.1246749,0.0008276049,0.0007047073,0.0008593051,0.0009914397,0.4680749,0.01707693,0.0453254,0.002624975,0.3344461],"study_design_scores_gemma":[0.00003923517,0.0007996821,0.01837686,0.00005732874,0.0002081265,0.0004117809,0.0002194412,0.9524583,0.01341092,0.01243365,0.00149297,0.00009161849],"study_design_candidate":"simulation_or_modeling","study_design_consensus":"simulation_or_modeling","genre_codex":"methods","genre_gemma":"methods","genre_scores_codex":[0.2172722,0.0004778919,0.7715169,0.0002604377,0.00005342062,0.0004660942,0.0003810706,0.001436474,0.008135509],"genre_scores_gemma":[0.9134873,0.00014667,0.08184098,0.00007835154,0.00002833454,0.0003313678,0.0005388894,0.0001686046,0.003379509],"genre_candidate":"methods","genre_consensus":"methods","teacher_disagreement_score":0.01475113,"threshold_uncertainty_score":0.07801241,"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."}}