{"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":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.03053298,0.0002036869,0.0002939207,0.004016536,0.0008902034,0.002620507,0.0008739025,0.0006535399,0.002620117],"category_scores_gemma":[0.05675474,0.0001987553,0.0007920454,0.00368043,0.001328366,0.0009823542,0.0008424007,0.0008532571,0.0004907495],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.004703376,"about_ca_system_score_gemma":0.004581495,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.008384798,"about_ca_topic_score_gemma":0.006048422,"domain_scores_codex":[0.9746234,0.008930502,0.002522638,0.002672697,0.0101276,0.00112321],"domain_scores_gemma":[0.9392625,0.03012487,0.01278414,0.00485611,0.01210183,0.0008705416],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"observational","study_design_scores_codex":[0.003377398,0.0008128502,0.441434,0.001531178,0.0008227907,0.0008752366,0.01351441,0.01066551,0.02402579,0.06442323,0.009887519,0.42863],"study_design_scores_gemma":[0.00008500661,0.001469693,0.8941414,0.000480805,0.0005157685,0.0007939475,0.003763736,0.005957418,0.01763229,0.003471076,0.07157528,0.0001136674],"study_design_candidate":"observational","study_design_consensus":"observational","genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9527208,0.003342011,0.008744081,0.0008629268,0.000172948,0.0004709166,0.001566704,0.0001948208,0.03192477],"genre_scores_gemma":[0.9913961,0.0004524267,0.004718562,0.0001741554,0.00003248147,0.00008131236,0.0007482058,0.00004683746,0.002349882],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.03053298,"threshold_uncertainty_score":0.1614757,"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."}}