Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee
October 9, 2003
TAB 1 Best Pharmaceuticals for Children Act, 2002. Sections 2 and 3 only for this discussion. http://www.fda.gov/cder/pediatric/PL107-109.pdf
TAB 2 Reference Articles
· Frost, B-M. Pharmacokinetics of Doxorubicin in Children With Acute Lymphoblastic Leukemia: Multi-Institutional Collaborative Study. Med Pediatr Oncol. 2002; 38:329-337.
· Groninger, E, et al. Pharmacokinetics of Vincristine Monotherapy in Childhood Acute Lymphoblastic Leukemia. Ped Rsch. 2002;2(1):113-118.
· Hempel, G, et.al. Peak plasma concentrations of doxorubicin in children with acute lymphoblastic leukemia or non-Hodgkin lymphoma. Canc Chemother and Pharm. 2001
· Nath, CE. Population pharmacokinetics of amphotericin B in children with malignant diseases. J Clin Pharmacol. 2001; 52:671-680.
TAB 3 List of Off-patent Oncology Drugs with abbreviated labeling (i.e., Indications section, Dosing and Administration section, and any sections containing pediatric information)
TAB 4 Approved Oncology Drugs with Pediatric Labeling, including abbreviated labeling (i.e., Indications section, Dosing and Administration section, and any sections containing pediatric information)
TAB 5 Anderson, B. Meeting Summary: NCI/CTEP Workshop – Cancer Pharmacology In Infants And Young Children. May 9, 2003.
TAB 1 Pawar, S. and Kumar, A. Issues in the Formulation of Drugs for Oral Use in Children – Role of Excipients. Pediatr Drugs. 2002; 4(6):371-379.
TAB 2 Nahata, MC. Pediatric Drug Formulations: Challenges and Potential Solutions. Annals of Pharmacother. Feb 1999; 33:247-249.
TAB 3 Kovarik, JM, et.al. Clinical Development of an Everolimus Pediatric Formulation: Relative Bioavailability, Food Effect, and Steady-State Pharmacokinetics. J Clin Pharmacol. 2003;43:141-147.
TAB 4 Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products – General Considerations. March 2003. http://www.fda.gov/cder/guidance/5356fnl.pdf
TAB 5 Guidance for Industry: Exposure-Response Relationships — Study Design, Data Analysis, and Regulatory Applications. April 2003. http://www.fda.gov/cder/guidance/5341fnl.pdf