Anti-Viral Prophylaxis Target Product Profile Guidelines

摘要

The Transformational Medical Technologies Initiative (TMTI) program was given broad guidance through the current Initial Capabilities Documents (ICDs) to develop broad-spectrum medical therapeutics to mitigate the negative operational impact of a biological attack. The therapeutic must be safe and effective, easy to use, and cause minimal side-effects. This Target Product Profile (TPP) guideline describes drug candidates or passive immune products to be used as prophylaxis to prevent disease due to viral pathogens. This Target Product Profile does not pertain to vaccine development. The prophylaxis candidates will be used to prophylax patients who have been exposed to the pathogen, and are asymptomatic.