FY20. TO3. NIDA PHARMACOKINETIC ANALYSIS RESOURCE CENTER. NIDA REF. NO. N01DA-19-8947. PERIOD OF PERFORMANCE: 09/01/2020 TO 02/28/2022.

Technical Resources International, Inc., Bethesda MD

Investigators

Abstract

The Contractor shall serve as a pharmacokinetic resource in support of the pharmacokinetic (PK) and pharmacodynamics (PD) aspects of the medications development. The contractor will provide support to clinical pharmacology/pharmacokinetic studies including interaction studies. The Contractor shall prepare study protocols, monitor clinical studies to assure that pertinent Food and Drug Administration(FDA) regulations are met, manage and process clinical and pharmacokinetic data, conduct PK, PD, and statistical analyses, and prepare study reports. The data/reports will be submitted to the FDA in support of INDs (Investigational New Drugs) and NDAs (New Drug Applications).