{"id":"W2594847000","doi":"10.1208/s12248-017-0068-6","title":"Global Harmonization of Comparator Products for Bioequivalence Studies","year":2017,"lang":"en","type":"article","venue":"The AAPS Journal","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":9,"is_retracted":false,"has_abstract":false,"ca_institutions":"Health Canada","funders":"World Health Organization","keywords":"Comparator; Harmonization; Bioequivalence; Product (mathematics); Innovator; Risk analysis (engineering); Medicine; Business; Computer science; Pharmacology; Engineering; Mathematics; Intellectual property; Pharmacokinetics","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":[0.07554149,0.0005585946,0.001650087,0.002653864,0.0005356738,0.003377349,0.002386061,0.002477899,0.007692327],"category_scores_gemma":[0.07092783,0.0005081231,0.002545134,0.003916477,0.00161743,0.002456884,0.003950188,0.003624464,0.001184828],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.002324917,"about_ca_system_score_gemma":0.006035313,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00203035,"about_ca_topic_score_gemma":0.001817338,"domain_scores_codex":[0.940457,0.04589627,0.00408883,0.002796817,0.005314248,0.001446731],"domain_scores_gemma":[0.9496703,0.01855432,0.005320427,0.01558399,0.009659754,0.00121121],"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":[0.008308688,0.001201133,0.01532243,0.004858294,0.002232409,0.0004031638,0.001294063,0.01605218,0.01563724,0.1326015,0.07084043,0.7312484],"study_design_scores_gemma":[0.006792292,0.007622308,0.190496,0.007560978,0.004355817,0.001999627,0.001531858,0.01316648,0.02723714,0.132529,0.6064471,0.0002614261],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"methods","genre_gemma":"other","genre_scores_codex":[0.2358549,0.06425263,0.3703255,0.06895026,0.005586225,0.006473402,0.02109603,0.002399764,0.2250613],"genre_scores_gemma":[0.8019702,0.007947827,0.1404629,0.02474594,0.001166078,0.002129399,0.01526011,0.0007451649,0.005572307],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.07554149,"threshold_uncertainty_score":0.3995063,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3103234213113339,"score_gpt":0.4072629099747468,"score_spread":0.09693948866341295,"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."}}