Nonclinical (Preclinical) Development
Nonclinical testing is conducted throughout all phases of drug development in order to assess the safety profile and pharmacokinetic and toxicokinetic (PK/TK) characteristics of candidate medicinal products. If the nonclinical (or preclinical) development is performed well, it can maximize the chances of success in the clinical development phases. Strategies for the nonclinical development of products follow general regulatory guidelines, but are also designed on a case-by-case basis according to the specifics of the drug. It is of key importance to design an optimal preclinical development program that allows the drug to be taken forward into the clinic (“e.g. IND package”), or a more extended nonclinical development plan allowing the drug to be taken into the next clinical phase, or to product registration (e.g. including 6 months tox, carcinogenicity study, reproductive toxicity etc). The project managers of Kinesis Pharma can guide the client though all these phases of drug development.
The non-clinical experts of Kinesis Pharma have 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. Questions that are handled by the Kinesis expert range from writing responses to questions obtained from authorities (FDA/EMA) to calculating a safe starting dose for a first-in-man study (NOAEL/MABEL) and from advising on specific study findings (e.g QTc prolongation, or unexpected deaths in a study) to proposing a strategy on how to deal with high levels of metabolites (MIST guideline). Also for obtaining a second opinion on any preclinical or nonclinical research issue/question, the Kinesis experts can be consulted.
The non-clinical experts work in close collaboration with the Kinesis Pharma project managers CMC, regulatory, QA and clinical specialists to ensure that nonclinical (or preclinical) development plans provide the most time-efficient and cost-effective strategy for clients.
- Pharmacokinetics and Toxicokinetics (PK/TK)
- Preclinical Project Management
- Preparation of non-clinical regulatory documentation and reports
- Nonclinical (preclinical) consultancy
"In non-clinical development you must always expect the unexpected!"
Ilonka van Hoof, Ph.D.,