« FDA and International Serious Adverse Events Consortium Release First Data on Genetic Basis of Adverse Drug Events | Main
Saturday, February 28, 2009
Phase I Dosing for Cancer Drugs Detailed in New ICH Guidance
FDA
News Source
FDA draft guidance
Phase I clinical trials of cancer drugs can include maximum tolerated doses and dose-limiting toxicity, an International Conference on Harmonisation (ICH) draft guidance says. The draft offers advice on conducting nonclinical studies of drugs intended for patients with advanced cancer and limited therapeutic options, along with suggestions for conducting Phase I clinical trials to assess drug safety. Comments are due April 20.