Disease Models Used in Nonclinical Studies

Disease models (pathophysiological models) are animal models developed to reproduce a specific disease or condition. In nonclinical studies to evaluate a new drug’s efficacy, disease models enable experiments in animals that exhibit symptoms and disease states similar to those of actual patients. When selecting a service provider, the availability of disease models required for your nonclinical studies is a critical consideration.

Importance of Disease Models

Using disease models can enable more accurate evaluation of a new drug’s efficacy prior to clinical trials, support prediction of a candidate compound’s potential benefits and risks, and help determine the development direction.

Disease Model Animals and iPSC-Derived Models

Successful development of animal disease models yields more reliable data and can accelerate the development of new drugs with strong therapeutic potential. For example, using disease models based on induced pluripotent stem cells (iPSCs) allows more human-like evaluation and may reduce the risk of development discontinuation. Because iPSCs are derived from human cells, they can detect effects and adverse findings that conventional animal models may not reveal.

Selecting a Disease Model

When selecting a disease model, it is essential to choose an animal model that can accurately reproduce the symptoms and pathophysiology of the condition you intend to treat. For example, in studies of antihypertensive efficacy, rats that readily develop hypertension are commonly used. Animal studies may begin with small animals such as rats and mice, and, as appropriate, extend to rabbits, dogs, monkeys, pigs, and goats.

Using humanized animals—animals engrafted with human organs, tissues, or cells, or animals in which certain genes are replaced with human genes—enables testing under conditions that are closer to human biology.