Phase I Dosing for Cancer Drugs Detailed in New ICH 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can include maximum tolerated doses and dose-limiting toxicity, an International Conference on Harmonisation (ICH) draft guidance says.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.
Washington Drug Letter