{"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":"codex-gemma-dda1882f352a","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.001741976,0.0002403596,0.00117309,0.0005442875,0.0001015721,0.00004780662,0.0004148918,0.0001375009,0.00001838846],"category_scores_gemma":[0.0001388887,0.0002052238,0.00004812144,0.002137469,0.001327642,0.0001885311,0.0001346294,0.0004382793,0.000001545186],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0002570061,"about_ca_system_score_gemma":0.001061967,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.004930776,"about_ca_topic_score_gemma":0.0007498706,"domain_scores_codex":[0.9975488,0.00006445123,0.001535123,0.0005005901,0.0001153324,0.0002357142],"domain_scores_gemma":[0.9978111,0.0001160383,0.001469679,0.0004153291,0.0001333189,0.00005456148],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"theoretical_or_conceptual","study_design_gemma":"not_applicable","study_design_scores_codex":[0.00001573813,0.00002357938,0.0005096919,0.001536499,0.00004326837,1.936825e-7,0.000348621,0.00001306602,0.00003038449,0.6705621,0.00007425739,0.3268426],"study_design_scores_gemma":[0.0005712899,0.00002142997,0.01253821,0.0004287583,0.00003754756,0.000004259825,0.00001458809,0.00237516,0.00003873391,0.009699547,0.973959,0.0003115148],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.02691364,0.9703535,0.00007040529,0.001103099,0.0003703269,0.0007533444,0.0000913679,0.000007053876,0.0003371946],"genre_scores_gemma":[0.3111918,0.687323,0.00009661505,0.001225218,0.00008409216,0.0000261296,0.0000200452,0.00002267196,0.00001044616],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9738847,"threshold_uncertainty_score":0.8368784,"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."}}