1. PRECLINICAL DRUG DEVELOPMENT CONSULTANCY

Kinesis consults to the pharmaceutical industry and biotechnology companies on the development of preclinical R&D strategies, ranging from exploratory development to the pivotal pre-clinical studies needed for regulatory filing. Often the transition from research to development starts with an exploratory selection procedure in which the most favorable candidate for development is chosen from a group of new molecules. In this stage of development emphasis is laid on screening assays on genotoxicity, metabolism and bioavailability.

A suitable drug candidate will proceed to a package of studies intended to start clinical studies. In this phase studies on acute toxicity, repeated dose toxicity in rodent and non-rodent, genotoxicity, safety pharmacology, in vitro metabolism, and (limited) ADME are being performed, leading to the Safety Assessment Document (SAD). If required for regularory and/or scientific reasons, studies are accompanied by toxicokinetic evaluation.

In support of the clinical development program and for regulatory submission, long term toxicology in rodents and non-rodents, fertility, teratology and other reproductive toxicology studies, radiolabeled ADME or AME-studies, in vitro metabolism and interaction studies, immunotoxicity, and carcinogenicity studies are being conducted, all according to OECD- and ICH guidelines. In principle all studies have to be performed under GLP.
Kinesis can act as project manager and study monitor for all non-clinical studies (see project management and study monitoring).

Address:

Lage Mosten 29
4822 NK Breda
The Netherlands
+31(0)76 54 80 666
+31(0)76 54 21 777 (Fax)

(c) 2003-2004 Kinesis, the Netherlands
info@kinesis-pharma.com