Oncology Pharmacology

Gill, JH

Abstract

Cancer is a complex life-threatening disease with patients having a poor prognosis and significantly reduced life expectancy, factors which significantly alter the risk-benefit balance in this therapeutic area. In contrast to other therapeutic areas, more emphasis is required on potential benefits of new treatments for advanced cancer balanced by a requirement to manage any resulting toxicity. The successful development of new treatments for cancer can have an immediate impact upon patient survival. It is therefore important that compounds with the greatest safety margin in nonclinical studies, involving significant efficacy and minimal toxicity, are identified and progressed rapidly. Therefore, the type and timing of nonclinical safety studies for anticancer therapeutics has significantly different goals and required outcomes relative to non-oncology therapeutics. Such issues and requirements have resulted in development of the ICH S9 guidelines, “Nonclinical Evaluation for Anticancer Pharmaceuticals” (ICH, 2010), the only ICH guidance currently devoted to a specific therapeutic area. The principle objectives of the S9 guidelines are to: 1) decrease the attrition rate of new cancer therapeutics, 2) increase the clinical dose escalation rate to attain an active dose, 3) reduce, refine and replace animal use for drug development studies, and 4) ultimately reduce the time taken for a cancer drug to enter the clinic. This chapter specifically describes screening methodology of particular relevance to oncology therapeutics, not covered in detail in other chapters, and defines the ICH S9 guideline suggested for oncology therapeutics.

Citation

Gill, J. (2013). Oncology Pharmacology. In H. Vogel, J. Maas, F. Hock, & D. Mayer (Eds.), Drug discovery and evaluation : safety and pharmacokinetic assays (573-593). (2nd). Springer Verlag. https://doi.org/10.1007/978-3-642-25240-2_20

• Publication Date: 2013
• Deposit Date: Mar 4, 2013
• Publisher: Springer Verlag
• Pages: 573-593
• Series Number: 1
• Edition: 2nd
• Book Title: Drug discovery and evaluation : safety and pharmacokinetic assays.
• ISBN: 9783642252396
• DOI: https://doi.org/10.1007/978-3-642-25240-2_20
• Public URL: https://durham-repository.worktribe.com/output/1682505
• Additional Information: In 2 volumes