Determination of sample sizes for demonstrating efficacy of radiation countermeasures.

ABSTRACT: In response to the ever increasing threat of radiological and nuclear terrorism, active development of nontoxic new drugs and other countermeasures to protect against and/or mitigate adverse health effects of radiation is ongoing. Although the classical LD(50) study used for many decades as a first step in preclinical toxicity testing of new drugs has been largely replaced by experiments that use fewer animals, the need to evaluate the radioprotective efficacy of new drugs necessitates the conduct of traditional LD(50) comparative studies (FDA, 2002, Federal Register 67, 37988-37998). There is, however, no readily available method to determine the number of animals needed for establishing efficacy in these comparative potency studies. This article presents a sample-size formula based on St

SUBMITTER: Kodell RL 

PROVIDER: S-EPMC3036987 | biostudies-literature | 2010 Mar

REPOSITORIES: biostudies-literature