1. Biological products: general provisions. Code of federal regulations. Title 21, sec 601. Washington, DC: US Government Printing Office, 1999.
2. Guidance for industry for the evaluation of combination vaccines for preventable diseases: production, testing and clinical studies. Rockville, MD: US Food and Drug Administration, Center for Biologics Evaluation and Research, 1997. Available at http://www.fda.gov/cber/guidelines.htm.
3. Falk LA, Midthun K, McVittie LD, Goldenthal KL. The testing and licensure of combination vaccines for the prevention of infectious diseases. In: Ellis R, ed. Combination vaccines. Totowa, NJ: Humana, 1999.
4. The Statistical Analysis of Immunognicity Data in Vaccine atials.