Preclinical Research Services

Comprehensive preclinical research is a key element of a successful Investigational New Drug (IND) application to the Food and Drug Administration (FDA). This will pave the way of a pharmaceutical company to testing an experimental drug in humans in clinical trials.

Before IND enabling preclinical research is begun, drug discovery and lead optimization must first be completed. This process is the study and identification of the chemicals which can prevent or treat diseases in the body and how they interact with targets that are part of the disease state or the cause of the disease. Lead compounds are screened and optimized to check their effectiveness against the targets.

After lead optimization is completed, preclinical research is highly focused toward demonstrating that compound will be safe once it is tested in humans. The lead compound undergoes toxicology testing both in test-tube (in-vitro) as well as in animals (in-vivo). Animal studies are performed to get an initial assessment of the viability of the drug. The primary goal of the pharmaceutical company is to have a good determination whether the drug is safe for human testing and if there is enough pharmacological activity in the lead compound to warrant a commercial development of their product.

PharmaDirections provides the expertise, the experience and the project team to design, oversee and execute complete IND enabling programs.