{"id":"W4226230176","doi":"10.18433/jpps32433","title":"Biosimilars: A Comparative Study of Regulatory, Safety and Pharmacovigilance Monograph in the Developed and Developing Economies","year":2022,"lang":"en","type":"review","venue":"Journal of Pharmacy & Pharmaceutical Sciences","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":13,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Biosimilar; Pharmacovigilance; Business; Risk analysis (engineering); Medicine; Pharmacology; Adverse effect","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":true,"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":[0.005466426,0.0004004754,0.001836482,0.0004822332,0.0003945686,0.00006376157,0.0009478988,0.0001019519,0.0002803089],"category_scores_gemma":[0.00009767413,0.0002283206,0.0002183645,0.001033658,0.001416081,0.0002333548,0.0003267811,0.001252181,9.967656e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0000758167,"about_ca_system_score_gemma":0.0004279942,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.000009741399,"about_ca_topic_score_gemma":0.000006656527,"domain_scores_codex":[0.9947998,0.00252087,0.001627467,0.000430022,0.0002044783,0.0004173704],"domain_scores_gemma":[0.9964638,0.002269359,0.001006547,0.0001210262,0.00006461021,0.00007462729],"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":[0.0004625594,0.0006713617,0.002202843,0.001474712,0.001032155,0.00005191157,0.002430749,0.000003497513,0.0001638361,0.0003377637,0.0006731735,0.9904954],"study_design_scores_gemma":[0.001851431,0.000363237,0.0002825764,0.0005326401,0.0009348725,0.0004335877,0.001972523,0.00002406291,0.0002462749,0.00004594696,0.9930269,0.0002859136],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.01161988,0.9863458,0.00001200378,0.0006814857,0.0003828787,0.0007331743,0.00002474407,0.000005704299,0.0001942927],"genre_scores_gemma":[0.01692426,0.98196,0.0004484835,0.0005849754,0.00004244198,0.00001765091,0.000001302614,0.000009447358,0.00001146848],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9923537,"threshold_uncertainty_score":0.9310642,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.3142194182936775,"score_gpt":0.4944116633944489,"score_spread":0.1801922451007714,"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."}}