Testing Therapeutic Potency of Anticancer Drugs in Animal Studies: A Commentary

• Published in: Regulatory toxicology and pharmacology Vol. 35; no. 2; pp. 266 - 272
• Main Authors: Den Otter, Willem, Steerenberg, Peter A., Van der Laan, Jan Willem
• Format: Journal Article
• Language: English
• Published: San Diego, CA Elsevier Inc 01-04-2002; Elsevier
• Subjects: Animals; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Disease Models, Animal; Drug Approval - economics; Drug Approval - legislation & jurisprudence; Drug Screening Assays, Antitumor - ethics; Drug Screening Assays, Antitumor - methods; Drug Screening Assays, Antitumor - standards; Drug Screening Assays, Antitumor - trends; General aspects. Methods; Medical sciences; Mice; Neoplasms, Experimental - drug therapy; Netherlands; Pharmaceutical industries; Public health. Hygiene; Public health. Hygiene-occupational medicine; Rats; Research Design - legislation & jurisprudence; Research Design - standards; Research Design - trends; Toxicology; Netherlands; drug screening assays—antitumor; antineoplastic agents; drug evaluation; drug approval; drug screening; drug evaluation standards; Antineoplastic agent; Methodology; Toxicity; Rodentia; Preclinical trial; Review; Research and development; Recommendation; Marketing; Marketing authorization; Chlorambucil; Vertebrata; Mammalia; Animal; Melphalan; Busulfan; Pharmaceutical industry; Mechanism of action
• ISSN: 0273-2300; 1096-0295
• DOI: 10.1006/rtph.2001.1522

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.