Pharmacokinetic Analyses Resource Center

Fast Track Drugs & Biologics, Llc, Gaithersburg MD

Investigators

Abstract

The main objective is to provide suppoert for Pharmacokenetic and Pharmacodynamic studies. This involves preparing study protocols, monitoring clinical studies, performaing data management and compling smf editing clinical data, conducting PK an dPD statistical analyses, and preparing detailed study reports. Reports will be prepared for eventual submisson to FDA in support of investigational new drugs and new drug applications.