Winkler, Gian Christian, Lovsin Barle, Ester, Galati, Giuseppe and Kluwe, William (2014) Functional differentiation of cytotoxic cancer drugs and targeted cancer therapeutics. Regulatory Toxicology and Pharmacology, on lin.

Abstract

There is no nationally or internationally binding definition of the term “cytotoxic drug” although this term is used in a variety of regulations for pharmaceutical development and manufacturing of drugs as well as in regulations for protecting medical personnel from occupational exposure in pharmacy, hospital, and other healthcare settings . The term “cytotoxic drug” is frequently used as a synonym for any and all oncology or antineoplastic drugs. Pharmaceutical companies generate and receive requests for assessments of the potential hazards of drugs regularly – including cytotoxicity. This publication is intended to provide functional definitions that help to differentiate between generically-cytotoxic cancer drugs of significant risk to normal human tissues, and targeted cancer therapeutics that pose much lesser risks. Together with specific assessments, it provides a comprehensible guidance on how to assess the relevant properties of cancer drugs, and how targeted therapeutics discriminate between cancer and normal cells. The position of several regulatory agencies in the long-term is clearly to regulate all drug classifications based on scientific risk based data. Despite ongoing discussions on how to replace the term “cytotoxic drugs” in current regulations, it is expected that its use will continue for the near future.

Item Type:	Article
Keywords:	Cytotoxic cancer drugs, antineoplastic drugs, selective oncology drugs, targeted therapeutics, functional definition, occupational health, pharmaceutical manufacturing, drug development
Date Deposited:	13 Oct 2015 13:13
Last Modified:	13 Oct 2015 13:13
URI:	https://oak.novartis.com/id/eprint/21226