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Indian Journal of Pharmacology
Medknow Publications on behalf of Indian Pharmacological Society
ISSN: 0253-7613
EISSN: 0253-7613
Vol. 37, No. 4, 2005, pp. 209-222
Bioline Code: ph05056
Full paper language: English
Document type: Research Article
Document available free of charge

Indian Journal of Pharmacology, Vol. 37, No. 4, 2005, pp. 209-222

 en Regulatory requirements and ICH guidelines on carcinogenicity testing of pharmaceuticals: A review on current status
Jena G.B., Kaul C.L., Ramarao P.

Abstract

International regulatory guidelines require that new chemical entities (NCEs) be tested first on animals (preclinical studies) for safety and efficacy before the start of clinical development. Long-term nonclinical studies such as carcinogenicity testing, the subject of the present review, is conducted in tandem with on-going clinical studies. Over the last few years, a number of regulatory changes have occurred in the regulatory requirements of carcinogenicity testing and the use of such data in human risk assessment process. The efforts are to provide a better mechanistic basis in interpretation of standard lifetime and short-term rodent bioassays. The major areas of focus of this review include the basic considerations for the lifetime rodent bioassay, the recommendations of the International Conference on Harmonization (ICH), and the development and validation of new short-term or alternative models for carcinogenicity testing. The objectives of these guidelines are to avoid the unnecessary use of animals in testing and to provide consistency in world wide regulatory assessments of applications. It will ultimately improve the precision in carcinogenicity testing, minimize the time requirement for such testing, and help to conserve the resources in the process of drug discovery and development.

Keywords
Carcinogenicity bioassay, cancer risk assessment, drug safety, cancer chemotherapy, preclinical toxicity tests, transgenic models

 
© Copyright 2005 Indian Journal of Pharmacology.
Alternative site location: http://www.ijp-online.com

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