Non-Clinical Development
A fast way to assurance of safety
Non-clinical testing is conducted throughout all phases of drug development in order to assess the safety profile and pharmacokinetic/toxicokinetic (PK/TK) characteristics of candidate medicinal products. If non-clinical development is performed well, it can maximize the chances of success in the clinical development phases. Strategies for the non-clinical development of products follow general regulatory guidelines, but are designed on a case-by-case basis according to the specifics of the drug. It is of key importance to design an optimal non-clinical development program that allows the drug to be taken forward to the next step in clinical development, or to product registration.
The non-clinical development department at Kinesis Pharma consists of a team of experienced non-clinical experts with a broad experience and hands-on drug development expertise with respect to design, monitoring, issue management and overall consultancy for PK/TK, metabolism, safety pharmacology and toxicology studies. These experts work in close collaboration with the Kinesis Pharma CMC, regulatory, QA and clinical specialists to ensure that non-clinical development plans provide the most time-efficient and cost-effective strategy for clients.
The Kinesis Pharma non-clinical experts can guide sponsors through all the phases of non-clinical development.
"In non-clinical development you must always expect the unexpected!"
Contact details:Ilonka van Hoof, Ph.D., |
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