{"id":"W2265434961","doi":"10.1177/2168479015597730","title":"Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28–29, 2014","year":2015,"lang":"en","type":"article","venue":"Therapeutic Innovation & Regulatory Science","topic":"Pharmaceutical studies and practices","field":"Medicine","cited_by":9,"is_retracted":false,"has_abstract":false,"ca_institutions":"SickKids Foundation; Institute for Clinical Evaluative Sciences; Hospital for Sick Children","funders":"Janssen Pharmaceuticals; U.S. Department of Health and Human Services","keywords":"Food and drug administration; Medicine; Regulatory science; Intensive care medicine; Pharmacy; Scientific evidence; Retinopathy of prematurity; Neonatal sepsis; Drug; Clinical trial; Pharmacology; Family medicine; Sepsis; Surgery; Pregnancy; Biology; Pathology","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.04979363,0.001149518,0.0005604914,0.00219404,0.003721666,0.004294357,0.002489001,0.01348687,0.006449887],"category_scores_gemma":[0.02508502,0.0006993735,0.001694428,0.001167431,0.002209397,0.003095693,0.00513935,0.008427645,0.001398937],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.005188123,"about_ca_system_score_gemma":0.0338788,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.009316092,"about_ca_topic_score_gemma":0.02111467,"domain_scores_codex":[0.984897,0.003685113,0.0007935918,0.0004996913,0.008341188,0.001783398],"domain_scores_gemma":[0.9768613,0.008619824,0.002434465,0.0005905692,0.008666246,0.002827478],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"not_applicable","study_design_gemma":"not_applicable","study_design_scores_codex":[0.0007360644,0.001687152,0.004512236,0.001668864,0.0001271903,0.0008961154,0.001328436,0.001130746,0.0293471,0.01886,0.7648625,0.1748435],"study_design_scores_gemma":[0.0001260236,0.0006092301,0.006862761,0.0006974055,0.00007476252,0.0003253897,0.001346193,0.0004687963,0.02713603,0.004329779,0.9579424,0.0000811952],"study_design_candidate":"not_applicable","study_design_consensus":"not_applicable","genre_codex":"commentary","genre_gemma":"other","genre_scores_codex":[0.02203758,0.06128042,0.01113765,0.8366016,0.0165706,0.001191852,0.001360325,0.0002063638,0.04961354],"genre_scores_gemma":[0.1727007,0.2009391,0.05456809,0.3780921,0.0165633,0.001869275,0.003916852,0.0003183537,0.1710322],"genre_candidate":"other","genre_consensus":null,"teacher_disagreement_score":0.04979363,"threshold_uncertainty_score":0.263337,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.04683733557958548,"score_gpt":0.3516666754475606,"score_spread":0.3048293398679752,"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."}}