{"id":"W1978578638","doi":"10.1016/j.clinthera.2010.09.014","title":"Challenges and opportunities in establishing scientific and regulatory standards for determining therapeutic equivalence of modified-release products: Workshop summary report","year":2010,"lang":"en","type":"article","venue":"Clinical Therapeutics","topic":"Drug Solubulity and Delivery Systems","field":"Pharmacology, Toxicology and Pharmaceutics","cited_by":12,"is_retracted":false,"has_abstract":false,"ca_institutions":"University of Saskatchewan","funders":"","keywords":"Bioequivalence; Medicine; Regulatory science; Equivalence (formal languages); Food and drug administration; Pharmacology; Medical physics; Risk analysis (engineering); Drug; Immediate release; Pharmacokinetics; Management science; Mathematics; Engineering","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":[0.1371801,0.001205551,0.001354551,0.001060642,0.002616481,0.007242906,0.005617591,0.01047118,0.004662389],"category_scores_gemma":[0.0457513,0.0009245005,0.002109029,0.0008658704,0.002247972,0.005229963,0.00587314,0.01007982,0.001318848],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.003877492,"about_ca_system_score_gemma":0.01900975,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003220301,"about_ca_topic_score_gemma":0.004660152,"domain_scores_codex":[0.9591804,0.01720066,0.004306442,0.002564333,0.01354276,0.003205381],"domain_scores_gemma":[0.946732,0.02083171,0.00361909,0.002515333,0.02323595,0.003066015],"domain_codex":null,"domain_gemma":"methods","domain_candidate":"methods","domain_consensus":null,"study_design_codex":"design_other","study_design_gemma":"not_applicable","study_design_scores_codex":[0.003406464,0.003478901,0.006341215,0.005921568,0.0006825446,0.00374899,0.009976582,0.009286178,0.1053644,0.05582305,0.1643849,0.6315852],"study_design_scores_gemma":[0.000672874,0.005230948,0.008393638,0.00318957,0.0004087327,0.002611921,0.01005949,0.004396092,0.1303896,0.03377353,0.8003364,0.0005372184],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"commentary","genre_gemma":"methods","genre_scores_codex":[0.1412997,0.1073078,0.2111372,0.419431,0.03673109,0.008640903,0.001970241,0.0006926405,0.07278951],"genre_scores_gemma":[0.5415708,0.05694202,0.264623,0.05369003,0.01215118,0.005129435,0.002461125,0.0006918143,0.0627406],"genre_candidate":"methods","genre_consensus":null,"teacher_disagreement_score":0.8628199,"threshold_uncertainty_score":0.7254863,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.5046181438480937,"score_gpt":0.506426698833964,"score_spread":0.001808554985870292,"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."}}