{"id":"W4401818898","doi":"10.1002/psp4.13216","title":"Development and comparison of model‐integrated evidence approaches for bioequivalence studies with pharmacokinetic end points","year":2024,"lang":"en","type":"article","venue":"CPT Pharmacometrics & Systems Pharmacology","topic":"Statistical Methods in Clinical Trials","field":"Mathematics","cited_by":6,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Hamilton Health Sciences Foundation","keywords":"Bioequivalence; Resampling; Type I and type II errors; Nonparametric statistics; Statistics; Sample size determination; Computer science; Sampling (signal processing); Confidence interval; Mathematics; Bioavailability","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.006510576,0.0005764161,0.001881948,0.001053095,0.0001611327,0.00008198823,0.0005785262,0.0001924206,0.00006347592],"category_scores_gemma":[0.008989189,0.0004315441,0.0001431268,0.002213345,0.0006686226,0.0002292427,0.0002640433,0.0005893085,0.00000853325],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002707714,"about_ca_system_score_gemma":0.0003482829,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000003713467,"about_ca_topic_score_gemma":6.003816e-7,"domain_scores_codex":[0.9943681,0.0009588084,0.002220333,0.00102164,0.0007298454,0.0007013051],"domain_scores_gemma":[0.9337394,0.06441307,0.0006540816,0.0002624925,0.0006181224,0.0003128527],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"simulation_or_modeling","study_design_scores_codex":[0.006981669,0.004687399,0.003010413,0.1232857,0.02123165,0.0003292797,0.01591573,0.009455176,0.2169397,0.1329783,0.08377475,0.3814102],"study_design_scores_gemma":[0.005083062,0.0008974632,0.00002395743,0.002333431,0.004321479,0.00007549884,0.001367558,0.7481447,0.2110543,0.0164878,0.00904633,0.001164436],"study_design_candidate":"simulation_or_modeling","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"empirical","genre_scores_codex":[0.2531434,0.06372334,0.671591,0.0005775618,0.005254922,0.004788199,0.0003447725,0.0004243464,0.0001525004],"genre_scores_gemma":[0.645086,0.001190454,0.3523525,0.00007919749,0.0002422144,0.0007830543,0.000003564579,0.00007915944,0.0001838956],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.7386895,"threshold_uncertainty_score":0.9998136,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8675392696483202,"score_gpt":0.634633286820038,"score_spread":0.2329059828282822,"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."}}