Drug Evaluation Committee Survey on Clinical Pharmacology Study and Clinical Pharmacology Evaluation of Anticancer Drugs in Approved Drugs in Japan
Clinical Evaluation Subcommittee
April 2020
The percentage of anticancer drugs in the approved drugs is on the increase. The development of anticancer drugs differs from that of non-oncology drugs in that patients are targeted from Phase I trials and the required non-clinical toxicity studies are different, and the background information related to the planning and execution of clinical pharmacology studies is different. In addition, for some drugs, some clinical pharmacology studies are conducted post-marketing, and the minimum package required for 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.