- Metabolic Stability
- CYP Interaction
- Permeability & Transporters
- Physicochemical Properties
- Protein Binding
Discovery PK and Toxicology
In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires the initiation of preclinical developmental and reproductive toxicology (DART) studies using mammalian research models. These regulated studies provide important information regarding the effects of drug exposures prior to and during parental mating, as well as evaluating maternal and fetal changes during gestation, and identifying any alterations in the development of the offspring following birth.
Need a refresher? Here’s a complete overview of what DART studies are and why they are essential.
Frontage has a highly trained technical staff and expert scientists with a long history of successfully performing specialized toxicology studies, including regulated developmental and reproductive toxicity studies. Specifically, we have the capabilities to do these studies following the ICH S5 (R3) Guideline:
Experimur, located in Chicago, Illinois, provides full service, GLP-compliant toxicology and related non-clinical development services supporting the pharmaceutical and biotechnology industries.Learn More
Frontage offers the portfolio of assays and designs to meet all regulatory requirements for IND in Genetic Toxicology testing.Learn More
Frontage provides comprehensive coverage by offering a wide selection of test species and multiple drug administration routes, to help prepare your compounds for IND and NDA submissions.Learn More