ABSTRACT
Toxicological test methods are necessary to assess the hazard and safety of various substances such as medicines, consumer products, and industrial chemicals. Many of these methods have traditionally used animals as the test system; however, in recent years, there has been increasing interest in developing alternative methods that reduce or replace animal use and that refine animal use to lessen or eliminate pain and distress. For any new or revised test method to be used to meet regulatory testing requirements, including alternative methods, the method must first undergo adequate validation and then be determined to be acceptable by regulatory authorities. This chapter discusses the criteria and processes for validation and regu-
latory acceptance of new, revised, and alternative methods. In addition, examples of new alternative test methods that have been accepted by national and international authorities are reviewed.
