Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

October 9, 2003

 

Background Documents

 

AM Session

 

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.

 

 

PM Session

 

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