The three Rs in the pharmaceutical industry : perspectives of scientists and regulators

• Main Author: Fenwick, Nicole Patricia
• Language: English
• Published: 2009
• Online Access: http://hdl.handle.net/2429/16739

Interviews with six drug regulatory reviewers and 11 pharmaceutical research scientists were used to explore their perspectives on obstacles and opportunities for greater implementation of the Three Rs (Replacement, Reduction, Refinement) in drug research and development. Participants generally supported the current level of animal use in the pharmaceutical industry and viewed in vitro methods as complementing, but not replacing, the use of animals. Obstacles to greater use of the Three Rs cited by participants included the lack of well-researched and validated non-animal alternatives; the need to use certain numbers of animals to achieve statistical validity; some regulatory requirements; reluctance by industry and regulators to depart from established patterns of animal use; the priority of commercial objectives ahead of the Three Rs; and concerns that less animal testing could jeopardize human safety. Opportunities identified for the Three Rs included the development of better animal models including genetically modified (GM) animals; pursuit of more basic knowledge, notably drug action on gene expression; re-use of animals in successive studies; greater use of pilot studies to avoid full-scale studies of unpromising drugs; using sufficient numbers of animals per test to avoid repeating inconclusive studies; regular review of animal data and regulatory requirements; and following the regulatory option of combining segments of reproductive toxicology studies into one study. In some areas greater implementation of the Three Rs seemed well aligned with industry priorities; examples included phenotypic characterization of GM animals and validation of alternative methods. In other areas, wider use of the Three Rs may require building consensus on areas of disagreement including the usefulness of death as an endpoint, the suitability of re-using animals, and whether GM animals and the use of pilot studies contribute to Reduction. The Three Rs, with their emphasis on decreasing use of animals, may also be incompatible with the goal of protecting human safety and the commercial objectives of the pharmaceutical industry. === Land and Food Systems, Faculty of === Graduate