Food and Drug Administration

Description

Narrow therapeutic index (NTI) drugs are those drugs where small differences in dose or blood concentration may cause serious adverse events or therapeutic failure. In 2011, FDA proposed tighter quality and bioequivalence (BE) standards for NTI drugs. These new standards will further enhance the quality and therapeutic equivalence of generic NTI drugs. One challenge in implementing tighter quality and bioequivalence (BE) standards for NTI drugs is to identify drugs that can be classified as NTI drugs. It is believed that dose adjustment and therapeutic monitoring data in clinical practice can provide insight about the drug dose/concentration and response relationship which may help determine which drug falls into NTI category and may need tighter review criteria.The objective of this application is to collect drug dose adjustment and therapeutic monitoring data in patients to aid NTI classification. The outcome of this study can help FDA develop a NTI drug list and implement the NTI policy.

Who can apply

• State governments
• County governments
• City or township governments
• Special district governments
• Independent school districts
• Public and State controlled institutions of higher education
• Native American tribal governments (Federally recognized)
• Public housing authorities / Indian housing authorities
• Native American tribal organizations (other than Federally recognized)
• Nonprofits with 501(c)(3) status (other than higher education)
• Nonprofits without 501(c)(3) status (other than higher education)
• Private institutions of higher education
• For-profit organizations other than small businesses
• Small businesses
• Others

Contact

Lisa Ko <br/>Grants Management Specialist
lisa.ko@fda.hhs.gov