{"id":"W4396623478","doi":"10.1002/cpt.3284","title":"Should You Run a Dedicated TQT Study? Sponsor and Regulatory Considerations on Substitution Pathways to Assess QT Liability","year":2024,"lang":"en","type":"review","venue":"Clinical Pharmacology & Therapeutics","topic":"Cardiac electrophysiology and arrhythmias","field":"Medicine","cited_by":8,"is_retracted":false,"has_abstract":true,"ca_institutions":"Celerion (Canada)","funders":"","keywords":"Drug; Medicine; Substitution (logic); Pharmacology; Business; Actuarial science; Computer science","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":[0.007214342,0.0004995153,0.001245155,0.001160828,0.0003171545,0.001740269,0.001346498,0.003151743,0.005868576],"category_scores_gemma":[0.008026727,0.0003356946,0.001206982,0.001037129,0.001071273,0.002903477,0.0007253436,0.004295626,0.003534818],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0007421195,"about_ca_system_score_gemma":0.002650107,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001142537,"about_ca_topic_score_gemma":0.002364316,"domain_scores_codex":[0.9978803,0.000890221,0.0003692359,0.0002122314,0.0005681221,0.0000798215],"domain_scores_gemma":[0.9936858,0.004737068,0.0005719743,0.0001398164,0.0007260588,0.0001392397],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.000149818,0.00005918184,0.0002166056,0.01320249,0.000079761,0.0002400628,0.0001514864,0.0002789503,0.0009139,0.01904869,0.05494901,0.9107101],"study_design_scores_gemma":[0.00008867896,0.0001709123,0.0005664209,0.01157839,0.0001071743,0.001698807,0.00008708268,0.000143735,0.0004376573,0.007933209,0.9771578,0.00003003702],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0003133039,0.9807382,0.001867098,0.009249532,0.001231059,0.00007465082,0.0001029781,0.00004175859,0.006381294],"genre_scores_gemma":[0.003103718,0.9804906,0.003731731,0.007857415,0.001260713,0.0001165623,0.0001360676,0.00001911463,0.003284058],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.007214342,"threshold_uncertainty_score":0.03815353,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.364157144340189,"score_gpt":0.5161278685460166,"score_spread":0.1519707242058275,"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."}}