11) Transformational Medical Technologies Initiative
Abstract
Multiagent (Broad Spectrum) Medical Countermeasures: Focuses on the initiation and completion of multiple preclinical studies for each new drug, to include safety, toxicity, efficacy, and scalability work in accordance with the product's intended use. The ability to formulate good manufacturing pilot lots and further mature promising drug candidates will be the focus of activities in this capability area. The preclinical drug discovery process culminates in the submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA), which conducts reviews and approves new drug candidates. Estimated attrition from preclinical phase to Phase I clinical studies is approximately 50%, thus not all drugs will survive the transition between preclinical development and Phase I studies.
Document Details
- Document Type
- Accomplishment
- Publication Date
- Oct 01, 2013
- Source ID
- 793d521e257aaddb87a581f08145f231