Supporting GLP Toxicology Studies
Formulation development can play an important role in providing maximum exposure of your drug candidate during toxicology studies. The challenge sometimes requires much higher exposure levels than clinical studies. A lack of exposure can severely trip up your GLP toxicology study. Investment in formulation upfront can help avoid costly delays. Therefore, formulation expertise with these studies is essential.
Pharmatek supports development of preclinical drug formulations for various routes of administration. Our goal is to develop a formulation for toxicology studies that can help optimize exposure, while:
• Conserving API
• Ensuring quick turnaround to meet aggressive timelines
• Targeting a formulation that is transferable and easy for the animal site to replicate and administer
• Building upon the development of a human formulation
If needed, Pharmatek can produce non-clinical formulations for shipment to testing facilities. We can also analyze your formulation by HPLC to determine chemical and physical stability. If you don’t have an HPLC method appropriate for this use, our experienced team can develop a “fit for purpose” method at this stage of development.