WMA (World Medical Association). 2008. Declaration of Helsinki: Ethical principles for medical research involving human subjects. http://www.wma.net/en/30publications/10policies/b3/17c.pdf (accessed April 3, 2012).
Working Group (Working Group on Antiretroviral Drug Development in HIV Infected and Exposed Neonates). 2003. Memorandum to the Pediatric Advisory Subcommittee of the Anti-Infective Drugs Advisory Committee. In Background package for March 3, 2003, advisory committee meeting. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/ohrms/dockets/ac/03/briefing/3932B1_01_FDA%20Backgrounder.pdf (accessed April 3, 2012).
Xiao, S. 2009. Clinical review for Benicar (olmesartan medoxomil). NDA 21286. December 4. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM201695.pdf (accessed April 3, 2012).
Yan, S. 2008. Statistical review for Zomig spray (zolmitriptan). NDA 21450. October 14. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM249246.pdf (accessed April 3, 2012).
Yancey, C. L. 2004. Clinical review for Arava (leflunomide). NDA 20905. March 5 (pp. 36-133 of approval package). Silver Spring, MD: Food and Drug Administration. http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/020905_S012_ARAVA.pdf (accessed April 3, 2012).
Yang, C. P., M. A. Veltri, B. Anton, M. Yaster, and I. D. Berkowitz. 2011. Food and Drug Administration approval for medications used in the pediatric intensive care unit: A continuing conundrum. Pediatric Critical Care Medicine 12(5):e195-e199. http://journals.lww.com/pccmjournal/Abstract/publishahead/Food_and_Drug_Administration_approval_for.99476.aspx (accessed April 3, 2012).
Yeh, T. F., Y. J. Lin, H. C. Lin, C. C. Huang, W. S. Hsieh, C. H. Lin, and C. H. Tsai. 2004. Outcomes at school age after postnatal dexamethasone therapy for lung disease of prematurity. New England Journal of Medicine 350(13):1304-1313.
Zhang, J. 2008. Clinical review for Abilify (aripiprazole). NDA 21436-017, 21713-012, 21729-004, 21866-004. August 14, 2008. Silver Spring, MD: Food and Drug Administration. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/-DevelopmentResources/ucm071737.pdf (accessed April 3, 2012).
Zuppa, A. F., S. C. Nicolson, J. S. Barrett, and M. R. Gastonguay. 2011. Population pharmacokinetics of pentobarbital in neonates, infants, and children after open heart surgery. Journal of Pediatrics 159(3):414-419.