Preclinical Toxicology Testing Services

Preclinical toxicology and related safety studies are a pivotal part of the drug development life cycle. They are needed to demonstrate that the test compound is safe, and at what doses, for administration to humans as part of clinical trials. Start your safety and toxicology program with a strong strategy that anticipates issues and avoids costly delays.  

According to advise from the USFDA, “The purpose of preclinical work–animal pharmacology/toxicology testing–is to develop adequate data to undergird a decision that it is reasonably safe to proceed with human trials of the drug” (FDA, Drug Development And Review). As such, these studies are absolutely critical to every IND development program.

Clinical trials are expensive and consequential. Well-designed preclinical toxicology can pre-empt potential hazards and provide key biological insights that guide development. We have explored these ideas in the context of medical devices in a white paper on the subject. 

Well designed preclinical toxicology studies begin with an understanding of which model is best suited to answer your question. Absorption Systems have extensive experience conducting toxicology studies that address:

• Sub-acute and long-term/chronic toxicology
• Specialised dose route or target compartments (e.g. ocular, dermal)
• Developmental toxicology
• Device and Safety Testing
• GLP Preclinical Studies
• IND Enabling Studies