Titre : | Testing therapeutic potency of anticancer drugs in animal studies : A commentary. (2002) |
Auteurs : | OTTER (Willem-Den) : NLD. Department of Cell Biology and Histology. Utrecht University. TD Utrecht. ; Peter-A STEERENBERG ; Jan-Willem VAN DER LAAN ; Laboratory of Pathology and Immunobiology. National Institute for Public Health and the Environment. BA Bilthoven. NLD ; Preclinical Assessment Group of the Medicines Evaluation Board in the Netherlands. Laboratory for Medicines and Medical Devices. National Institute for Public Health and the Environment. BA Bilthoven. NLD |
Type de document : | Article |
Dans : | Regulatory toxicology and pharmacology (vol. 35, n° 2, 2002) |
Pagination : | 266-272 |
Langues: | Anglais |
Mots-clés : | Médicament anticancéreux ; Commercialisation ; Industrie pharmaceutique ; Animal vertébré ; Animal ; Méthodologie ; Autorisation mise sur marché ; Recommandation |
Résumé : | [BDSP. Notice produite par INIST-CNRS j9UR0xyb. Diffusion soumise à autorisation]. 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. |