About FDA

Description: Animal studies are used during medical product development to predict toxicity in humans. These studies are time-consuming and rely heavily on testing approaches from the past century. New technologies (e.g., cell-based testing, computer modeling) are available, but need to be further explored, refined, and validated. ORSI is supporting efforts to develop testing approaches that reduce the number of animals needed for toxicology testing, use of lower animal species, use non-animal based toxicology models, improve predictability, make nonclinical studies more efficient, and, ultimately, reduce the time needed to initiate and complete clinical testing. As part of this effort, a request for application (RFA) is in planning for 2011 to identify collaborative partners in support of developing and validating modern toxicology testing approaches.

Accomplishment: Through the RFA mechanism we have awarded funding to 2 scientists to help support the development and validation of biomarkers specific to reproductive toxicity. Reproductive toxicity refers to the effects associated with some substances that can interfere with normal sexual function and fertility in adult males and females; reproductive toxicity can also cause developmental toxicities in offspring. It is critical to identify reproductive toxicities early in drug development before clinical testing in humans. The following two grantees were chosen: