{"id":"W4385514873","doi":"10.1002/cpt.3006","title":"Model‐Informed Drug Development: Steps Toward Harmonized Guidance","year":2023,"lang":"en","type":"article","venue":"Clinical Pharmacology & Therapeutics","topic":"Health Systems, Economic Evaluations, Quality of Life","field":"Economics, Econometrics and Finance","cited_by":27,"is_retracted":false,"has_abstract":true,"ca_institutions":"Health Canada","funders":"","keywords":"Harmonization; Drug development; Context (archaeology); Viewpoints; Consistency (knowledge bases); Guideline; Population; Medicine; Regulatory science; Risk analysis (engineering); Drug; Computer science; Pharmacology; Environmental health","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":["metaresearch"],"consensus_categories":[],"category_scores_codex":[0.2618731,0.003636094,0.006219249,0.007503993,0.003448892,0.02371377,0.01806447,0.02791991,0.009106057],"category_scores_gemma":[0.2714104,0.003505019,0.007323922,0.005030638,0.01556939,0.01859103,0.02352563,0.04255449,0.005427685],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.01793827,"about_ca_system_score_gemma":0.101992,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.01209,"about_ca_topic_score_gemma":0.01020989,"domain_scores_codex":[0.7574847,0.1713308,0.01894747,0.006873223,0.04088086,0.004482998],"domain_scores_gemma":[0.6937231,0.2138091,0.01321909,0.02314255,0.04611563,0.009990507],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"theoretical_or_conceptual","study_design_scores_codex":[0.0001835764,0.000596526,0.0005548905,0.005675805,0.0003857184,0.0004877885,0.003352391,0.02581263,0.0007030333,0.5486266,0.1794581,0.2341631],"study_design_scores_gemma":[0.0002949395,0.0002161203,0.0003245099,0.01479967,0.0001269622,0.0001973534,0.0008721905,0.01145692,0.0006630066,0.5600245,0.4108362,0.0001876205],"study_design_candidate":"theoretical_or_conceptual","study_design_consensus":"theoretical_or_conceptual","genre_codex":"commentary","genre_gemma":"methods","genre_scores_codex":[0.001267808,0.03085216,0.4508647,0.4775712,0.004008949,0.00307229,0.0006356154,0.001448117,0.03027929],"genre_scores_gemma":[0.02028177,0.02532258,0.8737738,0.07068198,0.001903342,0.00410857,0.001003668,0.0004174454,0.002506767],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.2618731,"threshold_uncertainty_score":0.9102418,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.7476456105265453,"score_gpt":0.5707018036775844,"score_spread":0.1769438068489609,"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."}}