{"id":"W2557563077","doi":"10.1038/pr.2016.221","title":"Safety, dosing, and pharmaceutical quality for studies that evaluate medicinal products (including biological products) in neonates","year":2016,"lang":"en","type":"review","venue":"Pediatric Research","topic":"Pharmaceutical studies and practices","field":"Medicine","cited_by":107,"is_retracted":false,"has_abstract":false,"ca_institutions":"","funders":"Health Canada; March of Dimes Foundation","keywords":"Medicine; Dosing; Clinical trial; Legislation; Drug development; Pharmaceutical industry; Alternative medicine; Clinical pharmacology; Intensive care medicine; Extant taxon; Quality (philosophy); Family medicine; Pharmacology; Drug; Political science; Pathology","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":[0.007154875,0.0008948156,0.00355218,0.005020447,0.0002717087,0.00163671,0.001182143,0.001965259,0.003195892],"category_scores_gemma":[0.01984972,0.0004572329,0.003435758,0.004386643,0.0008828427,0.001735491,0.0008738334,0.001422897,0.0003183011],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001082888,"about_ca_system_score_gemma":0.002807686,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.001877748,"about_ca_topic_score_gemma":0.004178124,"domain_scores_codex":[0.9957551,0.001216066,0.001673366,0.0003549168,0.0009200058,0.00008066023],"domain_scores_gemma":[0.9809544,0.01374887,0.004019433,0.0002738346,0.000890177,0.0001133655],"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":[0.0007007052,0.00008770052,0.001576881,0.289012,0.003813021,0.0001915787,0.000172456,0.0002255406,0.001171174,0.001425054,0.00370274,0.6979212],"study_design_scores_gemma":[0.00115356,0.00179648,0.02374009,0.4090917,0.05320081,0.004520165,0.000914066,0.0005072346,0.005637171,0.005332587,0.4938568,0.0002493675],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.0003225365,0.9992014,0.00007143699,0.000131939,0.00003080471,0.00001648777,0.00004665215,0.000001753932,0.0001771609],"genre_scores_gemma":[0.004828697,0.9939174,0.0006635069,0.0003105371,0.00007513629,0.0000273736,0.00006940315,0.000001707984,0.0001062732],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.007154875,"threshold_uncertainty_score":0.03783906,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.8245542632276731,"score_gpt":0.6651653830812282,"score_spread":0.1593888801464449,"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."}}