NDA-Enabling Clinical Pharmacology Studies
We often speak about the importance in early clinical research of collecting enough of the right data and information to support “clinical proof-of-concept” or “clinical proof-of-mechanism”, key go / no go decisions in drug development. Equally important, is the contribution that clinical pharmacology studies make to the eventual label of successful drug products in terms of understanding how age, gender, disease and other drugs affect drug disposition and eventually how the drug is to be prescribed by the practicing physician. Read more.
Types and Features of NDA Enabling Studies
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 in this article lists the different types and features of NDA-enabling clinical pharmacology studies. Read more.
Drug-Drug Interaction Studies: A year in review and growing trends
In the past year, both the FDA and the European Medicines Agency (EMA) issued revised guidelines on the conduct and analysis of drug-drug interaction studies (DDIs) to support the drug approval process. While some of the guidance carried over from previous versions, there were some notable additions which have impacted the scientific decision making process of sponsor organizations conducting these studies. Read more.
Overview: Capturing Efficiencies By Packaging NDA-Enabling Studies
Celerion has been involved in several hundred studies that back up statements in the “Clinical Pharmacology” sections of approved drug product labeling. This experience provides deep knowledge on various options in study design, as well as considerations for effective study conduct. Celerion has developed packages of these studies involving the same new drug candidate, often with several studies running in parallel to meet tight marketing submission deadlines. Read more.
Elliot Offman, BSc Pharm, MSc, Director, Clinical Pharmacology Sciences
Mr. Offman is the Director of Clinical Pharmacology Sciences at Celerion. In this role, Mr. Offman leads the North American team of clinical pharmacology scientists focused on protocol development, pharmacokinetics, pharmacodynamics, statistical data analysis and report production. Read more.
Neptune Facility Overview
Celerion has had a strong presence in Neptune, New Jersey for over 20 years. The facility offers a complete array of clinical research services with 130 beds and an intensive care unit with 24 beds. Read more.