In this chapter, we propose a new, pragmatic approach that could accelerate the replacement of most, if not all, regulatory animal tests with superior tests based on human biology. We also propose that changes to the requirements for safety testing, issued by the us Food and Drug Administration (fda), must be made in order to enable the use of superior new tests, which are currently disadvantaged by the outdated language of the regulations. But first, it is imperative to establish some level of understanding of the efficacy of existing animal-based methods in order to know whether any possible replacement is better or worse.
Archibald, K., Coleman, R., & Drake, T. (2019). Replacing animal tests to improve safety for humans. In Animal Experimentation: Working Towards a Paradigm Change (pp. 417-442). Brill.