{"id":"W3048183018","doi":"10.32553/jbpr.v9i4.781","title":"STUDY ON REGISTRATION AND REGULATORY REQUIREMENTS FOR VACCINES IN USA, EUROPE AND CANADA","year":2020,"lang":"en","type":"article","venue":"Journal of Biomedical and Pharmaceutical Research","topic":"Pharmaceutical studies and practices","field":"Medicine","cited_by":0,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"","keywords":"Marketing authorization; Authorization; European commission; Pharmacovigilance; Agency (philosophy); License; European union; Medicine; Licensure; Commission; Drug approval; Member states; Business; Political science; Pharmacology; Adverse effect; Drug; Computer security; International trade; Computer science; Finance; Medical education; Law","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":[0.002110663,0.00009399204,0.0002833989,0.00008315655,0.000112284,0.00003255687,0.00006401784,0.00004408151,0.00004889863],"category_scores_gemma":[0.002262126,0.00006217762,0.00001783407,0.0002237937,0.0002004165,0.00009295082,0.00009313473,0.0006825491,7.664652e-7],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0000432728,"about_ca_system_score_gemma":0.0002445022,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001245602,"about_ca_topic_score_gemma":0.001287347,"domain_scores_codex":[0.9980393,0.0002224031,0.0004046012,0.0001965474,0.000867077,0.000270068],"domain_scores_gemma":[0.9977167,0.001087151,0.00007078936,0.00004683104,0.0002124304,0.0008661303],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"not_applicable","study_design_scores_codex":[0.03467074,0.003503221,0.5313432,0.002341344,0.0009120555,0.004256456,0.002128222,8.003681e-7,0.03788779,0.001151318,0.07537872,0.3064261],"study_design_scores_gemma":[0.01307013,0.009818972,0.3684604,0.0002431918,0.0001915848,0.0002122509,0.001682182,0.001152422,0.001048234,0.0001633368,0.6037823,0.0001750342],"study_design_candidate":"observational","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9213434,0.001815413,0.00001330482,0.0760005,0.00006701276,0.0003889407,0.000004381806,0.00000135909,0.0003656288],"genre_scores_gemma":[0.9952432,0.002069582,0.00006135809,0.002201389,0.0003282244,0.00000492123,7.180495e-7,0.000006880485,0.00008375382],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.5284036,"threshold_uncertainty_score":0.2965374,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.4037205327928215,"score_gpt":0.5363496367445819,"score_spread":0.1326291039517604,"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."}}