1) TMTI
Abstract
Multiagent Broad Spectrum Medical Countermeasures - Upon Milestone A approval, this effort will advance experimental broad-spectrum drug candidates with an accepted Investigational New Drug (IND) from the Food and Drug Administration (FDA) through the Technology Development phase. This includes the initiation and completion of Phase I clinical studies, where a new drug is introduced into humans, and early evidence is gathered on drug safety. Approved performers who have had their IND applications accepted by the FDA will initiate Phase 1 clinical trials and other studies necessary to support a Milestone B decision progress toward a New Drug Application (NDA) with the FDA. Phase I trials are the first stage of drug testing in human subjects in a relatively small (between 20-100) group of healthy human volunteers. Trials are designed to assess the safety pharmacokinetics (characteristic interactions of a drug and the body in terms of its absorption, distribution, metabolism and excretion) and pharmacodynamics (the action or effects of drugs on living organisms) of a drug. Phase I trials often include dose-ranging or dose escalation studies so that the appropriate dose for therapeutic use can be found. The tested range of doses will usually be a fraction of the dose that causes harm in animal testing.
Document Details
- Document Type
- Accomplishment
- Publication Date
- Oct 01, 2011
- Source ID
- c3e9886928e283652be5bd9f865a388e