Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Chiltern International, a contract research organisation (CRO), has entered into collaboration with Charles River Laboratories to conduct and support early phase radiolabelled studies.
Subscribe to our email newsletter
The Metabolism and Pharmacokinetics group at Charles River, has 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.
Additionally, 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.
Glenn Kerkhof, CEO of Chiltern, said: “This new partnership is an exciting collaboration. Charles River’s reputation is 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.”