Adverse Event Detection and Labeling in Pediatric Drug Development: Antiretroviral Drugs

Conclusions:
The adult adverse event experience provides preliminary data for pediatric drug safety, yet the specific types of adverse effects and frequencies may not be predicted in children based exclusively on adults. As adult safety data do not fully inform the pediatric safety profile, pediatric safety studies should continue to be conducted separately for drugs undergoing testing in pediatric patients.

Source: Therapeutic Innovation and Regulatory Science - February 27, 2015 Category: Drugs & Pharmacology Authors: Momper, J. D., Chang, Y., Jackson, M., Schuette, P., Seo, S., Younis, I., Abernethy, D. R., Yao, L., Capparelli, E. V., Burckart, G. J. Tags: Special Populations Source Type: research