Current Concepts for Development of the Nonclinical Toxicology Package for Novel Preventive Vaccines
Author:
Robert V. House, M.S.P.H., Ph.D.Summary:
Although vaccines are responsible for immeasurable improvements in human health, DVC President Dr. Robert V. House explains that all vaccines have inherent risks. Due to biological differences in the diseases, and the state of the science in animal models, animal safety studies continue to be designed on a case-by-case basis. Vaccines exhibit numerous characteristics that make safety assessment unique. These include diversity of physiochemical characteristics, nonstandard dose-response relationships, and with live agents, self-replication. Study design for toxicity and overall safety of vaccines must consider routine endpoints, as well as specialized parameters that are unique to the vaccine.
Dr. House presented this as part of the course "Biologics Drug Development: Manufacturing, Nonclinical, Clinical and Regulatory Overview" in San Francisco, Calif., on December 11, 2007.
