{"id":"W2940236078","doi":"10.30895/1991-2919-2019-9-1-41-48","title":"Post-approval Variations to Dossiers for Vaccines: Analysis of Regulatory and Methodological Approaches Used in the Russian Federation and Abroad","year":2019,"lang":"en","type":"article","venue":"The Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products Regulatory Research and Medicine Evaluation","topic":"Biosimilars and Bioanalytical Methods","field":"Immunology and Microbiology","cited_by":2,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Health Canada","keywords":"Russian federation; Political science; Drug approval; Business; Medicine; Pharmacology; Economic policy","routes":{"ca_aff":false,"ca_fund":true,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch"],"consensus_categories":["metaresearch"],"category_scores_codex":[0.07196752,0.0001399323,0.0004744588,0.0003745761,0.0003954986,0.00002080531,0.0002987598,0.0001344032,0.0002408271],"category_scores_gemma":[0.01131781,0.00006566077,0.0000756556,0.0009120438,0.001476366,0.00003626318,0.00009123842,0.0001768929,4.19272e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0000610383,"about_ca_system_score_gemma":0.0002600625,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00007069026,"about_ca_topic_score_gemma":0.00004007275,"domain_scores_codex":[0.9936149,0.003899831,0.0006450781,0.0005353873,0.001032472,0.0002723168],"domain_scores_gemma":[0.9950827,0.002572918,0.0002665063,0.0005644541,0.001469588,0.00004387791],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"bench_or_experimental","study_design_gemma":"observational","study_design_scores_codex":[0.004153073,0.0007270794,0.003212862,0.0008657914,0.001598605,8.029817e-8,0.04908653,0.0006516947,0.7254062,0.030097,0.02794185,0.1562593],"study_design_scores_gemma":[0.01972083,0.00502744,0.6468115,0.00110223,0.007664277,0.00002568665,0.06488931,0.07588686,0.1274904,0.02453307,0.02624745,0.0006010003],"study_design_candidate":"bench_or_experimental","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.8869582,0.005037775,0.0003181285,0.1016992,0.0004339249,0.005415855,0.00002847594,0.00000386184,0.0001045634],"genre_scores_gemma":[0.9977694,0.00002977975,0.001115361,0.0001177543,0.0000678623,0.0001212797,0.00007074307,0.000006689512,0.0007011142],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.6435986,"threshold_uncertainty_score":0.9970103,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.2449855838722964,"score_gpt":0.4456368126196436,"score_spread":0.2006512287473472,"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."}}