Types and Features of NDA Enabling Studies
J. Fred Pritchard, Ph.D.
Vice President, Global Drug Development
NDA-enabling studies such as drug-drug interactions, food effect and ADME are required to support a marketing application. Celerion is able to proactively create efficient and cost-effective packages of NDA-enabling studies, thereby allowing the same team of scientists to apply knowledge of the drug across all studies when performing the conduct and analysis. The table below lists the different types and features of NDA-enabling clinical pharmacology studies.