New regulatory framework for cancer drug development

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Recent changes to non-clinical cancer guidelines offer a golden opportunity to expedite the translation of new anticancer drugs into the clinic. In this article Paul S. Jones and David Jones look at how these guidelines can be implemented and how they can be integrated with non-clinical and clinical study design to produce robust and safe clinical trials.

The authors review the new regulatory framework for cancer drug development with specific reference to the international ICH S9 guideline on nonclinical evaluation of anticancer drugs. The authors discuss the implications of this guideline for the design of both preclinical safety and efficacy programmes and early phase clinical trials.

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