1. Pellock JM. Pediatric trials: practical issues. Special populations and trial designs. Adv Neurol 1998;76: 167–171.
2. Guidance for Industry: Ell clinical investigation of medicinal products in the pediatric population. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologies Evaluation and Research. December 2000. Available at: http://www.fda.gov/cder/guidance/4099fnl.pdf.
3. Best Pharmaceuticals for Children Act (BPCA). Public Law 107–109. January 4, 2002. Available at: http://thomas.loc.gov/bss/dl07/d1071aws.html.
4. Pediatric Research Equity Act (PREA). Public Law 108–155. December 3, 2003. Available at: http://thomas.loc.gov/bss/d108/d1081aws.html.
5. Additional safeguards for children in clinical investigations of FDA-regulated products. U.S. Department of Health and Human Services, Food and Drug Administration. April 2001. 66 Federal Register 20589-20600. Available at: http://www.fda.gov/ohrms/dockets/98fr/042401a.htm.