The U.S. Food and Drug Administration is committed to animal welfare in research by reducing, replacing and/or refining the use of animals in research, whenever possible.
The aim is this: by doing a single study to help establish a non-animal based model, it can potentially replace much of the need to use dogs in future trials with new informatics tools. The goal is to do one single study involving a small number of dogs—where the dogs will only be subject to minimally invasive blood sampling, and adopted as pets at the completion of the short trial—to eliminate the need for the use of dogs in certain types of future studies, some where they might have been euthanized.
The proposed study is part of the FDA’s overall efforts to help reduce reliance on animals used for research conducted by the agency’s scientists, as well as research conducted by industry. In fact, if validated, this study could provide a new tool for animal drug developers to use in their own research for certain products and help them generate data in support of applications submitted to the agency without the use of animals. This is one example of several activities that the FDA is conducting to help provide industry with modern approaches to data generation that do not require the use of animals.
The agency is optimistic that cultivating these types of new research approaches can help continue to reduce the need for animal testing.
Specifically, the goal of the study is to validate a research model for the comparison of blood levels of certain orally-administered canine drugs, in order to provide an alternative approach that animal drug developers can use to generate data needed to support the FDA’s approval of these types of drugs without the use of dogs during the research process. The study would compare the bioequivalence of tablets containing both locally and systemically acting antiparasitic drugs that are already widely used in dogs and well-tolerated. Drugs that act locally are not absorbed into an animal’s blood stream, while systemically acting drugs are absorbed into the blood stream. For antiparasitic drugs that act locally within the gastrointestinal tract, this has historically required data gathered from terminal studies, meaning the animals were artificially infected with gastrointestinal parasites and then euthanized at the conclusion of the study so that researchers could physically examine the GI tract for parasites or parasite damage, to evaluate whether the drug was effective. The goal of the model we’re aiming to develop is to reduce or eliminate these research practices.
In the study, no dogs would be euthanized. Instead, the proposed study would place dogs into three groups and, over the course of several months, they’ll receive a total of three pills. After each pill is administered, our researchers will draw a small amount of blood from the dogs at specified intervals to measure the concentration of the drugs in the blood and compare them against existing data for these products.
The FDA is dedicated to providing the utmost care for all animals used as part of our research. In January 2018, the agency established a new Animal Welfare Council to provide centralized oversight of all animal research activities and facilities under its purview. This council advises the agency on its approach to animal welfare issues and ensures alignment of animal studies with the agency’s mission.
