A Basic Overview Of In Vitro IND Enabling Studies

Thousands of new compounds enter drug discovery and development each year. Depending on the specific pharmaceutical compound, some are suitable for the market and some are not.

Before any new drug becomes accessible to the public, in the United States, the new drug must be approved by the U.S. Food and Drug Administration (FDA). Part of being given U.S. FDA approval includes gaining acceptance to undergo human clinical trials to ensure the pharmaceutical compound will be safe for public use. A critical step in gaining permission to begin clinical trials is acquiring the status of Investigational New Drug (IND). Gaining IND status requires submitting an IND application to the FDA for review. When submitting an IND application to the U.S. FDA, the FDA recommends a number of studies that should be done to seek a successful IND acceptance. These studies are known as IND enabling studies.

The US FDA recommended IND Enabling studies focus on determining if a new drug candidate will be safe to proceed to human clinical trials. These experiments focus on two key areas, the evaluation of potential safety risk due to toxicity issues and the evaluation of potential liabilities due to poor pharmacokinetics parameters. When running an  in vitro drug discovery program toxicology data is acquired through cytotoxicity assays and pharmacokinetic data is generated through running In vitro ADME screens.

How Companies Begin IND Enabling Studies For An FDA IND Application

After the lead compound has been chosen, the company seeking a successful IND application will begin the process of running many of the FDA’s recommended IND enabling studies. These studies will either be run in-house, for larger companies with in-house in vivo or in vitro capabilities, or they will be outsourced to a contract research organization (CRO). If outsourcing the work, companies will very often ask multiple research organizations for quotes and then decide on the CRO with the best quality proposal and pricing. Once these studies have been initiated the organization seeking the FDA status of Investigational New Drug will be responsible for compiling the data from the CRO and presenting the research to the FDA with their application for the IND.

Outputs From A Successful IND Submission

After the drug candidate is given the status of Investigational New Drug, applications are sent out for volunteers to participate in clinical trials. Clinical trials are well known to be one of the most important steps in drug development making a successful IND application a top priority for pharmaceutical companies seeking to bring a new drug to market.