|
Designs for carcinogenicity studies generally follow the guidelines published by the ICH, but are also designed to comply with the requirements of all the regulatory agencies including FDA, JMHW and CPMP (for Europe). ITR Canada has performed carcinogenicity studies by oral gavage and inhalation exposure, but can also offer topical and parenteral administration as appropriate for the expected human dosing route. Sprague Dawley rats are the strain commonly used in carcinogenicity studies and ITR Canada ensures acceptable survival by restricting feeding thereby restraining bodyweight and increasing longevity. Due to their extended duration and large group sizes, carcinogenicity studies are the most expensive studies in a pre-clinical program with prices in the range of C$1 million to C$5 million. |
