EMEA Requirements on Pre-Clinical Evaluation of Anticancer Medicinal Products

Beschreibung

Before a new drug candidate is given to clinical trial participants its safety has to be established in an adequate program of pre-clinical safety studies. The entry of new anticancer treatments into Phase I Clinical trials is ordinarily based on relatively modest pre-clinical data. But there is no universally accepted approach to the development of anticancer drugs. There were big differences between regulatory requirements between USA, Japan and Europe. And there are no typical programs - every pharmaceutical must be considered individually. Since it is recognized that doses of anticancer drugs high enough to kill cancer cells usually induce serious side effects in patients, the pre-clinical testing of oncology drugs differs from testing of non-oncology drugs. The presentation is intended primarily to recommend a basic framework for the pre-clinical safety evaluation of anticancer drugs. In general the goals of the pre-clinical safety evaluation are: - to determine principle areas of risk and potential target organs for toxicity, - to characterize toxic effects with respect to dose dependency, relationship to exposure and potential reversibility, - to identify safety parameters which allow clinical monitoring of possible toxicities in humans, and - to identify a safe starting dose and subsequent dose escalation schemes for human trials. The following endpoints should be addressed prior to the initiation of First-in-man clinical trial: - Safety Pharmacology, - Toxicology studies, - Toxicokinetic and Pharmacokinetic studies, - Genetic toxicology studies, - Local tolerance studies, - Reproduction toxicity studies, and - other endpoints applicable to specific materials. The presentation gives an overview over the pre-clinical development of anticancer drugs. The current EMEA requirements and guidelines are commented.

Zeitraum	12 Juni 2008 → 14 Juni 2008
Ereignistitel	CESAR Annual Meeting
Veranstaltungstyp	Sonstiges