Detalhe da pesquisa
1.
A review of pregnancy and lactation postmarketing studies required by the FDA.
Pharmacoepidemiol Drug Saf
; 32(3): 287-297, 2023 03.
Artigo
Inglês
| MEDLINE | ID: mdl-36401739
2.
The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities.
J Allergy Clin Immunol
; 147(6): 2009-2020, 2021 06.
Artigo
Inglês
| MEDLINE | ID: mdl-33713765
3.
Paediatric extrapolation: A necessary paradigm shift.
Br J Clin Pharmacol
; 85(4): 675-679, 2019 04.
Artigo
Inglês
| MEDLINE | ID: mdl-30403304
4.
Enhancing clinical trial development for pediatric kidney diseases.
Pediatr Res
; 82(5): 727-732, 2017 Nov.
Artigo
Inglês
| MEDLINE | ID: mdl-28853726
5.
Standardizing Safety Assessment and Reporting for Neonatal Clinical Trials.
J Pediatr
; 219: 243-249.e1, 2020 04.
Artigo
Inglês
| MEDLINE | ID: mdl-31708158
6.
Assessing congenital malformation risk from medications used in pregnancy: The contribution of NBDPS in pregnancy labeling of prescription drug products.
Birth Defects Res A Clin Mol Teratol
; 103(8): 718-20, 2015 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-26223007
7.
Defining new surrogate markers for CKD progression.
Pediatr Nephrol
; 30(2): 193-8, 2015 Feb.
Artigo
Inglês
| MEDLINE | ID: mdl-25370779
8.
Protecting Pregnant Women With Substance Use Disorders and Their Neonates Participating in Research.
JAMA
; 322(7): 609-610, 2019 Aug 20.
Artigo
Inglês
| MEDLINE | ID: mdl-31298683
9.
Healthcare providers' use of a concise summary to prescribe for lactating patients.
Res Social Adm Pharm
; 20(5): 531-538, 2024 May.
Artigo
Inglês
| MEDLINE | ID: mdl-38413289
10.
Expanding research to provide an evidence base for nutritional interventions for the management of inborn errors of metabolism.
Mol Genet Metab
; 109(4): 319-28, 2013 Aug.
Artigo
Inglês
| MEDLINE | ID: mdl-23806236
11.
A Comparison of FDA and EMA Pregnancy and Lactation Labeling.
Clin Pharmacol Ther
; 113(6): 1251-1257, 2023 06.
Artigo
Inglês
| MEDLINE | ID: mdl-36645246
12.
Clinical Lactation Studies of Neuropsychiatric Medications: Clinical Pharmacology and Labeling Considerations.
J Clin Pharmacol
; 63 Suppl 1: S159-S169, 2023 06.
Artigo
Inglês
| MEDLINE | ID: mdl-37317496
13.
Evaluation of FDA Labeling Changes Related to PREA Safety-Waivers.
Ther Innov Regul Sci
; 57(5): 1099-1103, 2023 09.
Artigo
Inglês
| MEDLINE | ID: mdl-37389793
14.
Considerations and Challenges in the Remdesivir COVID-19 Pediatric Development Program.
J Clin Pharmacol
; 63(2): 259-265, 2023 02.
Artigo
Inglês
| MEDLINE | ID: mdl-36149807
15.
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
Inglês
| MEDLINE | ID: mdl-36150423
16.
Overcoming Barriers to Drug Development in Children with CKD.
Clin J Am Soc Nephrol
; 18(8): 1101-1107, 2023 08 01.
Artigo
Inglês
| MEDLINE | ID: mdl-37055225
17.
Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation.
Ther Innov Regul Sci
; 57(1): 109-120, 2023 01.
Artigo
Inglês
| MEDLINE | ID: mdl-36057747
18.
Pharmacokinetic Evaluation in Pregnancy-Current Status and Future Considerations: Workshop Summary.
J Clin Pharmacol
; 63 Suppl 1: S7-S17, 2023 06.
Artigo
Inglês
| MEDLINE | ID: mdl-37317499
19.
Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design.
Arthritis Rheumatol
; 75(10): 1856-1866, 2023 10.
Artigo
Inglês
| MEDLINE | ID: mdl-37067688
20.
The role of immune tolerance induction in restoration of the efficacy of ERT in Pompe disease.
Am J Med Genet C Semin Med Genet
; 160C(1): 30-9, 2012 Feb 15.
Artigo
Inglês
| MEDLINE | ID: mdl-22253234