Chiltern International and Charles River Laboratories to study radiolabelled drug products

Feb 22 2010

Chiltern International Limited, a global contract research organization (CRO), announced its latest collaboration with Charles River Laboratories, Inc. As part of this collaboration, Chiltern Early Phase will partner with Charles River to conduct and support early phase radiolabelled studies.

Glenn Kerkhof, Chiltern CEO, stated, "This new partnership is an exciting collaboration. Charles River's reputation is world-renowned for their conduct of studies using radiolabelled investigational products.  Their extensive experience includes submission and review procedures for radiolabelled studies in man, including dosimetry calculations and submission to ARSAC. The clinical aspects of the radiolabelled studies will be performed by Chiltern Early Phase in Dundee, Scotland. These complementary strengths add a new dimension to the full CRO services that Chiltern already provides, continuing to demonstrate our commitment to providing our clients with the highest standard of quality and expertise."

Chiltern Early Phase has a dedicated 42-bed clinical pharmacology unit located in a UK National Health Service hospital and leading medical school. Established in 1982, Chiltern Early Phase has performed more than 700 clinical pharmacology studies in all routes of administration across major therapeutic areas. With more than 27 years of experience, Chiltern Early Phase has robust processes in place and its hospital-based location provides a full suite of safety monitoring with 24/7 access to hospital-based crash teams and hospital specialists for therapeutic area expertise and patient recruitment. In addition, Chiltern Early Phase offers an extensive database of healthy volunteers and other patient populations. Chiltern Early Phase's long pedigree in clinical pharmacology combined with Charles River's radiolabel capabilities are poised to provide the industry with unrivalled experience and expertise in early phase radiolabelled ADME studies.

The Metabolism and Pharmacokinetics group at Charles River, Edinburgh, have been conducting radiolabelled trials in man for more than 20 years. The facility includes a GMP clean room, licensed for the manufacture of radiolabelled drug products, including aseptic products for parenteral use. The close proximity of the laboratories allows a rapid turn around of radioactivity data (within 24 hours). Human metabolites can also be characterised by liquid chromatography with accurate mass, mass spectroscopy and concurrent radio-detection.