{"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":"codex-gemma-dda1882f352a","candidate_categories":["metaresearch","metaepi_narrow"],"consensus_categories":[],"category_scores_codex":[0.02507566,0.0006044689,0.00292109,0.0006522757,0.0005450901,0.000066959,0.0003845487,0.0003786221,0.00008470934],"category_scores_gemma":[0.03673616,0.0003233353,0.000223822,0.001492168,0.0009064347,0.0001732071,0.001154576,0.002040108,0.00006203655],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0005776244,"about_ca_system_score_gemma":0.0008929915,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.00002724999,"about_ca_topic_score_gemma":0.000003277571,"domain_scores_codex":[0.9913478,0.00268892,0.001288159,0.001592775,0.001584913,0.00149739],"domain_scores_gemma":[0.9806678,0.01693067,0.0003735787,0.0004830336,0.001119151,0.0004257344],"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":[0.0009534844,0.0002380358,0.001656666,0.06800746,0.0004550786,0.00007217829,0.0001816496,1.37083e-8,0.000007292485,0.0002200655,0.003963875,0.9242442],"study_design_scores_gemma":[0.002161681,0.0004892273,0.0002838817,0.003822192,0.00120105,0.00009046525,0.0001661716,0.000005657616,0.00001480167,0.0004258183,0.9909495,0.0003895577],"study_design_candidate":"not_applicable","study_design_consensus":null,"genre_codex":"review","genre_gemma":"review","genre_scores_codex":[0.000438272,0.9775831,0.000004793292,0.0154281,0.0004785314,0.005415611,0.00006438413,0.00005142236,0.0005357496],"genre_scores_gemma":[0.0004996464,0.9933578,0.00037176,0.00009950619,0.004244184,0.0008367996,0.00003678636,0.00005805352,0.0004954792],"genre_candidate":"review","genre_consensus":"review","teacher_disagreement_score":0.9869856,"threshold_uncertainty_score":0.9999219,"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."}}