{"id":"W2522289024","doi":"","title":"Regulatory consideration of the assessment of biosimilar products","year":2013,"lang":"en","type":"article","venue":"Journal of Bioequivalence & Bioavailability","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Harmonization; Scope (computer science); Interchangeability; Risk analysis (engineering); Business; Product (mathematics); Order (exchange); Bioequivalence; Medicine; Biotechnology; Pharmacology; Computer science; Finance; Pharmacokinetics","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":[0.1133766,0.00134259,0.001839237,0.004764536,0.002417055,0.009836876,0.005188024,0.0221872,0.003395591],"category_scores_gemma":[0.1391113,0.0008146903,0.003320185,0.002536074,0.00693711,0.004803856,0.002877118,0.00841897,0.002126062],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004171154,"about_ca_system_score_gemma":0.01849566,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.003384735,"about_ca_topic_score_gemma":0.002557809,"domain_scores_codex":[0.8138182,0.08749231,0.01415302,0.00510043,0.07639045,0.003045561],"domain_scores_gemma":[0.8548957,0.05606262,0.01484545,0.009207921,0.06197143,0.003016748],"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":[0.000913584,0.0006398964,0.005088442,0.005939271,0.0003923908,0.001864678,0.001874209,0.004260248,0.03518632,0.3346041,0.1713731,0.4378637],"study_design_scores_gemma":[0.0002575972,0.001679577,0.007955804,0.007094353,0.0003537483,0.001871617,0.0008651254,0.003692233,0.01609416,0.05719886,0.9027463,0.0001906188],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"other","genre_gemma":"empirical","genre_scores_codex":[0.04987418,0.147407,0.1157354,0.1878648,0.02224637,0.004700141,0.00235439,0.00154721,0.4682705],"genre_scores_gemma":[0.5835955,0.06831435,0.1425575,0.1275357,0.01433024,0.004530062,0.002635496,0.0006217986,0.05587925],"genre_candidate":"empirical","genre_consensus":null,"teacher_disagreement_score":0.1133766,"threshold_uncertainty_score":0.5995997,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0237267121275939,"score_gpt":0.2906560368767194,"score_spread":0.2669293247491255,"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."}}