A final guidance from the International Conference on Harmonisation (ICH) is designed to speed access to treatments for patients with advanced cancer. The guidance, which focuses on the design and conduct of nonclinical studies to develop therapies for patients who have limited treatment options, clarifies parts of the draft version, released in February 2009, including intended patient populations, recovery groups for general toxicology studies and nonclinical studies to support changes in a clinical dosing schedule.
The guidance document can be accessed here >>
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