Drug Evaluation Committee Case Study on Clinical Pharmacology Study and Clinical Pharmacology Evaluation of Anticancer Drugs in Japan
Clinical Evaluation Subcommittee
April 2020
Anticancer drugs account for an increasing proportion of approved drugs. The development of anticancer drugs differs from that of non-oncology drugs in terms of background information related to the planning and conduct of clinical pharmacology studies, such as the fact that anticancer drugs are developed in patients from Phase I trials and the non-clinical toxicity studies required are different. In addition, for some drugs, some clinical pharmacology studies are conducted post-marketing, and the minimum package required to obtain approval may differ from that for nononcology drugs. The Clinical Pharmacology Study Sub-Team of the Continuing Task Force 8 of the Clinical Evaluation Committee examined the clinical pharmacology packages of anticancer drugs approved in Japan in recent years and developed a document to serve as a guide for companies to develop their own clinical pharmacology packages. We hope that this document will be of help to companies in planning their packages and clinical pharmacology studies.
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