The pharmaceutical IND or “Investigational New Drug” submission to the FDA is a key mile-stone for pharmaceutical companies. Once the IND application is approved, the new drug candidate is usually cleared to enter early stage clinical trials. A successful IND application provides data consistent with FDA guidelines. Recently revised FDA guidelines on Drug-drug interactions is an important data set. IONTOX employes the latests in vitro technology, to provide data sets consistent with FDA guidelines.
Below is a list of in vitro studies that provide important information on a new drug candidates ADME properties and potential drug-drug interactions that can be used to support the IND submission: