Detalhe da pesquisa
1.
A Comparison of Pediatric and Adult Safety Studies for Antipsychotic and Antidepressant Drugs Submitted to the United States Food and Drug Administration.
J Pediatr
; 208: 236-242.e3, 2019 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-30679050
2.
Development of a Generic Fetal Physiologically Based Pharmacokinetic Model and Prediction of Human Maternal and Fetal Organ Concentrations of Cefuroxime.
Clin Pharmacokinet
; 63(1): 69-78, 2024 01.
Artigo
em Inglês
| MEDLINE | ID: mdl-37962827
3.
Promoting Clinical Trial Diversity: A Highlight of Select US FDA Initiatives.
Clin Pharmacol Ther
; 113(3): 528-535, 2023 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-36514867
4.
Pediatric Efficacy Extrapolation in Drug Development Submitted to the US Food and Drug Administration 2015-2020.
J Clin Pharmacol
; 63(3): 307-313, 2023 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-36150423
5.
Pediatric and Adult Placebo Response Rates in Placebo-Controlled Clinical Trials Submitted to the US Food and Drug Administration 2012-2020.
J Clin Pharmacol
; 62(8): 970-982, 2022 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-35118684
6.
Pediatric Drug Development Studies for Familial Hypercholesterolemia Submitted to the US Food and Drug Administration Between 2007 and 2020.
J Clin Pharmacol
; 62(3): 397-408, 2022 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-34562277
7.
Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives.
Ther Innov Regul Sci
; 55(2): 282-303, 2021 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-32901443
8.
Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling.
Front Pediatr
; 9: 698611, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-34381745
9.
Hypothalamic-Pituitary-Adrenal Axis Pediatric Safety Studies Submitted to the FDA.
Ther Innov Regul Sci
; 55(3): 622-630, 2021 05.
Artigo
em Inglês
| MEDLINE | ID: mdl-33544387
10.
Drug Safety in Labeling for Pediatric Drug Development and Dose Selection in Submissions to the US Food and Drug Administration.
J Clin Pharmacol
; 61 Suppl 1: S133-S140, 2021 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-34185899
11.
Inclusion of Infants and Neonates in Pediatric Orphan Product Approvals.
Clin Pharmacol Ther
; 110(4): 997-1003, 2021 10.
Artigo
em Inglês
| MEDLINE | ID: mdl-34028811
12.
Mechanistic Modeling of Placental Drug Transfer in Humans: How Do Differences in Maternal/Fetal Fraction of Unbound Drug and Placental Influx/Efflux Transfer Rates Affect Fetal Pharmacokinetics?
Front Pediatr
; 9: 723006, 2021.
Artigo
em Inglês
| MEDLINE | ID: mdl-34733804
13.
Inclusion of Adolescents in Adult Clinical Trials: Report of the Institute for Advanced Clinical Trials for Children's Pediatric Innovation Research Forum.
Ther Innov Regul Sci
; 55(4): 773-778, 2021 07.
Artigo
em Inglês
| MEDLINE | ID: mdl-33811302
14.
Physiologically Based Pharmacokinetic Modeling Framework to Predict Neonatal Pharmacokinetics of Transplacentally Acquired Emtricitabine, Dolutegravir, and Raltegravir.
Clin Pharmacokinet
; 60(6): 795-809, 2021 06.
Artigo
em Inglês
| MEDLINE | ID: mdl-33527213
15.
Combined Pediatric and Adult Trials Submitted to the US Food and Drug Administration 2012-2018.
Clin Pharmacol Ther
; 108(5): 1018-1025, 2020 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-32394430
16.
Prediction of Maternal and Fetal Pharmacokinetics of Dolutegravir and Raltegravir Using Physiologically Based Pharmacokinetic Modeling.
Clin Pharmacokinet
; 59(11): 1433-1450, 2020 11.
Artigo
em Inglês
| MEDLINE | ID: mdl-32451908
17.
Physiologically Based Pharmacokinetic Models to Predict Maternal Pharmacokinetics and Fetal Exposure to Emtricitabine and Acyclovir.
J Clin Pharmacol
; 60(2): 240-255, 2020 02.
Artigo
em Inglês
| MEDLINE | ID: mdl-31489678
18.
Monoclonal Antibodies and Fc-Fusion Proteins for Pediatric Use: Dosing, Immunogenicity, and Modeling and Simulation in Data Submitted to the US Food and Drug Administration.
J Clin Pharmacol
; 59(8): 1130-1143, 2019 08.
Artigo
em Inglês
| MEDLINE | ID: mdl-30865317
19.
Surrogate Endpoints in Pediatric Studies Submitted to the US FDA.
Clin Pharmacol Ther
; 105(3): 555-557, 2019 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-30094815
20.
Pediatric Drug Development: Outlook for Science-Based Innovation.
Clin Pharmacol Ther
; 103(3): 376-378, 2018 03.
Artigo
em Inglês
| MEDLINE | ID: mdl-29384202