Facilitators and barriers to the successful implementation of pediatric antibacterial drug trials: Findings from CTTI's survey of investigators
Tài liệu tham khảo
Mathis, 2009, Drug therapy in pediatrics: a developing field, Dermatol. Ther., 22, 257, 10.1111/j.1529-8019.2009.01239.x
U.S. Food and Drug Administration (FDA). Food and Drug Administration Modernization Act (FDAMA) of 1997. Available at: https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDAMA/default.htm. Accessed June 20, 2017.
U.S. Food and Drug Administration (FDA). Pediatric Product Development. Available at: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/ucm049867.htm. Accessed June 20, 2017.
National Institutes of Health. Best Pharmaceuticals for Children Act (BPFC). Available at: https://bpca.nichd.nih.gov/Pages/default.aspx. Accessed June 20, 2017.
U.S. Food and Drug Administration (FDA). Breakdown of FDAAA Completed Pediatric Studies. Available at: http://www.fda.gov/drugs/developmentapprovalprocess/developmentresources/ucm190622.htm. Accessed June 20, 2017.
U.S. Food and Drug Administration (FDA). New Pediatric Labeling Information Database. Available at: http://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?sd=labelingdatabase. Accessed June 20, 2017.
Institute of Medicine. Safe and Effective Medicines for Children: Pediatric Studies Conducted under the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 2012. Available at: https://www.nap.edu/catalog/13311/safe-and-effective-medicines-for-children-pediatric-studies-conducted-under. Accessed October 17, 2016. PMID:24872968. doi:10.17226/13311.
Institute of Medicine Committee on Clinical Research Involving Children, 2004, The national academies collection: reports funded by national institutes of health
Nambiar, 2014, Antibacterial drug development: challenges, recent developments, and future considerations, Clin. Pharmacol. Ther., 96, 147, 10.1038/clpt.2014.116
Rex, 2013, A comprehensive regulatory framework to address the unmet need for new antibacterial treatments, Lancet Infect. Dis., 13, 269, 10.1016/S1473-3099(12)70293-1
Hsu, 2014, Treatment of multidrug-resistant Gram-negative infections in children, Clin. Infect. Dis., 58, 1439, 10.1093/cid/ciu069
Clinical Trials Transformation Initiative (CTTI). Addressing Scientific and Regulatory Challenges in Pediatric Clinical Trials for Antibacterial Drugs. Available at: http://www.ctti-clinicaltrials.org/what-we-do/ctti-projects/pediatric-ab-trials. Accessed June 20, 2017.
