Studies Database

Chen E and Everitt J. Animal use in pharmaceutical drug discovery and development - current status and future directions. Paper presented at: The Three Rs - Together it's possible. 8th World Congress on Alternatives and Animal Use in the Life Sciences; 2011 Aug 21-25; Montreal, Canada

The pharmaceutical industry researches and develops new, safe and efficacious medicines for patients. The process that leads to the development of a new medicine is long and complex and involves the use of animals at multiple points of the drug discovery and development process. While in vitro assays play a significant role in high throughput screening of potentially active molecules during the early stages of the discovery process, studies with animal models are essential to elucidate disease mechanisms and demonstrate efficacy. Furthermore, regulatory agencies require evaluation of the safety of potential medicines in animals before entry into humans and then later in the drug development process. Therefore, to successfully bring forth new medicines to patients, the pharmaceutical industry requires staff with a wide range of skills in the conduct of in vivo studies with both rodent and non-rodent species.
However, many pharmaceutical companies are committed to finding and implementing approaches that aim to Refine, Reduce and Replace (3Rs) the use of animals in discovery and development programs for new therapeutics. Through recent advances in scientific knowledge and technologies, alternatives to testing on animals, such as the use of physiologically based pharmacokinetics modeling, is increasingly being adopted as part of the drug discovery and development strategies.
While these methods enable reduction in the number of animal experiments and in the number of animals used in each experiment, they do not completely eliminate animal use in pharmaceutical development. Several examples will be provided to demonstrate how these approaches have been used in conjunction with animal studies during the drug discovery and development process.

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