{"id":"W3001328276","doi":"10.1007/s43441-020-00114-6","title":"Complex Generic Products: Insight of Current Regulatory Frameworks in US, EU and Canada and the Need of Harmonisation","year":2020,"lang":"en","type":"review","venue":"Therapeutic Innovation & Regulatory Science","topic":"Pharmaceutical Economics and Policy","field":"Economics, Econometrics and Finance","cited_by":19,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"","keywords":"Biosimilar; Authorization; Competitor analysis; Business; Competition (biology); Product (mathematics); Harmonization; Law and economics; Medicine; Marketing; Computer science; Economics; Computer security; Biology","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.004025175,0.0006875002,0.00226618,0.002812583,0.0003372615,0.003474981,0.001389834,0.001959914,0.005660094],"category_scores_gemma":[0.005004269,0.0003456939,0.001340246,0.005297946,0.001580389,0.002482041,0.001020766,0.002758394,0.0006492414],"about_ca_system_candidate":true,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.007429737,"about_ca_system_score_gemma":0.01478278,"about_ca_topic_candidate":true,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.04513146,"about_ca_topic_score_gemma":0.09366588,"domain_scores_codex":[0.9987355,0.0002630424,0.0001455754,0.0001582908,0.0005584711,0.0001391244],"domain_scores_gemma":[0.9952406,0.003059759,0.0006411978,0.00009640976,0.0008388309,0.0001233151],"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":[0.0003009039,0.00006744564,0.00043395,0.04212422,0.0004090652,0.0001635843,0.0001540504,0.001730858,0.0007396219,0.07023484,0.02662846,0.8570129],"study_design_scores_gemma":[0.00008158191,0.00008600093,0.003554754,0.02800175,0.0005262971,0.0004030577,0.0002068045,0.000399314,0.0003080593,0.01425785,0.9521281,0.00004637177],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0002836764,0.9967975,0.0001437904,0.001341833,0.00008540251,0.000006870329,0.00007999117,0.000003358193,0.001257551],"genre_scores_gemma":[0.003124463,0.9950442,0.0003671462,0.0009482547,0.00007490142,0.000007073837,0.00007554851,0.000003099953,0.0003553054],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9925703,"threshold_uncertainty_score":0.08973753,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.1479457426015912,"score_gpt":0.3219237387184541,"score_spread":0.1739779961168629,"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."}}