Pharmaceutical toxicology: designing studies to reduce animal use, while maximizing human translation

Regul Toxicol Pharmacol. 2013 Jun;66(1):88-103. doi: 10.1016/j.yrtph.2013.03.001. Epub 2013 Mar 21.


Evaluation of the safety of new chemicals and pharmaceuticals requires the combination of information from various sources (e.g. in vitro, in silico and in vivo) to provide an assessment of risk to human health and the environment. The authors have identified opportunities to maximize the predictivity of this information to humans while reducing animal use in four key areas; (i) accelerating the uptake of in vitro methods; (ii) incorporating the latest science into safety pharmacology assessments; (iii) optimizing rodent study design in biological development and (iv) consolidating approaches in developmental and reproductive toxicology. Through providing a forum for open discussion of novel proposals, reviewing current research and obtaining expert opinion in each of the four areas, the authors have developed recommendations on good practice and future strategy.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animal Testing Alternatives / methods*
  • Animals
  • Drug-Related Side Effects and Adverse Reactions*
  • Humans
  • Research Design
  • Risk Assessment / methods
  • Rodentia
  • Species Specificity
  • Toxicology / methods*
  • Translational Medical Research / methods