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Testing Therapeutic Potency of Anticancer Drugs in Animal Studies: A Commentary
Ist Teil von
Regulatory toxicology and pharmacology, 2002-04, Vol.35 (2), p.266-272
Ort / Verlag
San Diego, CA: Elsevier Inc
Erscheinungsjahr
2002
Link zum Volltext
Quelle
Elsevier Journal Backfiles on ScienceDirect (DFG Nationallizenzen)
Beschreibungen/Notizen
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.