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In Vitro Solutions For the Pharmaceutical Industry

IONTOX scientists utilize a combined 50 years of experience in drug discovery with a specialized understanding of in vitro toxicology to help our clients identify liabilities early and decrease late-stage attrition. IONTOX provides data packages for each step of the drug discovery pathway.

Hit- to- Lead:

Hit -to- lead cytotoxicity screens (measuring cell death or cell viability): This assay is designed to be high or low throughput. Endpoints can be varied as needed. Human or rodent cell models can be employed. The risk of mitochondrial toxicity can be isolated. The data obtained are used to provide information on the relative toxicity of compounds in a series.

Lead Optimization and Candidate Selection Cytotoxicity Screening:

Optimizing druggable attributes and the selection of a lead candidate is a milestone event in drug discovery. Many important data sets are reviewed when making a candidate selection. The success of a new drug candidate can be significantly improved by identifying potential issues related to toxicity. The IONTOX-CytotoxPanel combines dose-response data from multiple assays for cell health to provide a blood concentration that would be expected to cause toxicity in rodents. The predictive accuracy of this model has been shown with more than 300 drugs.

Cytotoxicity panel

IND Enabling Studies:

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: