Drug Regulators, FDA, Publish Guidance S9 Nonclinical Evaluation for Anticancer Pharmaceuticals
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The purpose of this guidance is to provide information to assist in the design of an appropriate program of nonclinical studies for the development of anticancer pharmaceuticals. The guidance provides recommendations for nonclinical evaluations to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options.
This guidance aims to facilitate and accelerate the development of anticancer pharmaceuticals and to protect patients from unnecessary adverse effects, while avoiding unnecessary use of animals, in accordance with the 3R principles (reduce/refine/replace), and other resources.
As appropriate, the principles described in other ICH guidances should be considered in the development of anticancer pharmaceuticals. Specific situations where recommendations for nonclinical testing deviate from other guidance are described in this document.
Because malignant tumors are life-threatening, the death rate from these diseases is high, and existing therapies have limited effectiveness, it is desirable to provide new, effective anticancer drugs to patients more expeditiously.
There have been no internationally accepted objectives or recommendations on the design and conduct of nonclinical studies to support the development of anticancer pharmaceuticals in clinical trials for the treatment of patients with advanced disease and limited therapeutic options. Nonclinical evaluations are conducted to:
(1)
identify the pharmacologic properties of a pharmaceutical,
(2)
establish a safe initial dose level for the first human exposure, and
(3)
understand the toxicological profile of a pharmaceutical (e.g., identification of target organs, exposure-response relationships, and reversibility).
In the development of anticancer drugs, clinical studies often involve cancer patients whose disease condition is progressive and fatal. In addition, the dose levels in these clinical studies often are close to or at the adverse effect dose levels. For these reasons, the type, timing, and flexibility called for in the design of nonclinical studies of anticancer pharmaceuticals can differ from those elements in nonclinical studies for other pharmaceuticals.
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