Testing therapeutic potency of anticancer drugs in animal studies: a commentary.
Regulatory authorities for medicines in European countries deal with many applications for admission to the market of anticancer drugs. Each application must be supported by preclinical and clinical data, among which testing of the therapeutic activity of drugs in animals is important. Recently, the Committee for Proprietary Medicinal Products (CPMP) has released a note for guidance on the preclinical evaluation of anticancer medicinal products. This note provides only general statements regarding tests of anticancer drugs in rodents. This stimulates considerations on how to organize and how to evaluate these tests. In this article we describe our considerations regarding these items based on our experience with applications in The Netherlands since 1993.
Den Otter
Willem
W
Preclinical Assessment Group of the Medicines Evaluation Board in the Netherlands, Laboratory for Medicines and Medical Devices, 3720 BA Bilthoven, The Netherlands.
Steerenberg
Peter A
PA
Van der Laan
Jan Willem
JW
D000818:Animals; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D004195:Disease Models, Animal; D017277:Drug Approval / Q000191:economics / Q000331:legislation & jurisprudence; D004354:Drug Screening Assays, Antitumor / Q000941:ethics / Q000379:methods* / Q000592:standards / Q000639:trends; D051379:Mice; D009374:Neoplasms, Experimental / Q000188:drug therapy*; D009426:Netherlands; D051381:Rats; D012107:Research Design / Q000331:legislation & jurisprudence / Q000592:standards / Q000639:trends
D000970:Antineoplastic Agents