Animal Models: Practical Use and Considerations

Abstract

This chapter discusses the use of animal models in the preclinical drug discovery and development process. The different types of animal model studies ranging from: in vivo pharmacokinetic, pharmacodynamic, disease/mechanism and toxicology studies are discussed. Depending upon the type of study being conducted the optimal species and animal model must be decided. The validity of these models in terms of how they replicate the clinical signs (Face), onset of the disease (Construct) and can predict effective treatments (Predictive) is key in selecting the correct animal model. Important considerations such as conforming to ethical and legal requirements, deciding on a studies objective(s) and selecting the endpoint(s) to be measured must be considered before the research is undertaken. During the animal model study, consideration of the route of administration and drug formulation are key in maximizing bioavailability. Accurate statistical analysis and scientific reporting are essential in ensuring animal studies conform to the 3Rs of replacement, reduction and refinement. This chapter also covers the benefits and limitations of using animal models in preclinical drug development, where animal research is heading, and the importance bidirectional research plays in it.