5) TMTI
Abstract
Broad Spectrum Medical Countermeasures: Activities during this phase will include Phase 2 clinical trials, which will test the efficacy of therapeutics. Because the therapeutics sought are for biological warfare (BW) indications, efficacy testing on humans cannot be performed and will be tested in animals only. Because of the lack of human efficacy data, trials in animals are considered to be "Pivotal Animal Efficacy Studies" and are most commonly performed on at least two species of animals, to include non-human primates. Activities will also include expanded human and animal safety and/or animal efficacy studies as directed by the Food and Drug Administration (FDA) to support a New Drug Application (NDA) submission.
Document Details
- Document Type
- Accomplishment
- Publication Date
- Oct 01, 2011
- Source ID
- 818a2da3a14dc6cdbd37bd357540af32