Case Study

Novel Preclinical Safety Studies

Connect with an expert opens in a new page


The Department of Defense developed a new nerve agent antidote that will be critical to the survival of service members who are exposed to these threats on the battlefield. The unique properties of the drug’s toxicity levels limited the ability to test the compound in humans, which was delaying regulatory advancement. As a result, Battelle was tasked with performing preclinical safety studies to determine cause of toxicity in preclinical models in order to limit the maximum concentration (Cmax) and area under the curve (AUC) exposure in humans.

The Solution

Battelle evaluated the human data and determined that while AUC levels were being exceeded, the Cmax was not. Our researchers designed a series of novel studies to demonstrate that toxicity was linked to the Cmax, but not the AUC. The studies determined the cause of the toxicity and recommended a treatment for human exposure.
Ready to get started? Contact us today for a free, no-obligation assessment.
Connect with an expert opens in a new page

The Outcome

Based on the Battelle data and recommendations, the FDA allowed the completion of a pivotal human safety study. The Department of Defense is now investigating the possibility of obtaining an emergency use authorization for this compound.
We facilitate scientific discovery, improves health outcomes while promoting health equity.
Explore Precision Public Health opens in a new page

Case Studies

Technology Commercialization and Licensing

With over 90 years of research and development experience, Battelle supports all areas of industry with intellectual property licensing focused on bringing our cross-disciplinary expertise to meet our clients' most difficult challenges.

Explore our ip

Photo: Abstract photo of a lightbulb