FDA researchers are working to develop a new informatics model to reduce the reliance on dogs to conduct studies in animal drug development.
The agency’s new study, which was proposed on Friday, is intended to aid animal drug developers in conducting certain research without the need for product testing on dogs.
Animal drug developers would be able to use the new model as a mechanism for comparing blood levels of certain orally-administered canine drugs to support FDA approval based on their existing research.
The FDA will conduct a 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 validate the model, FDA Commissioner Scott Gottlieb said. “By using the data we generate from these blood tests to establish a clear benchmark for how these drugs are absorbed in the dogs’ blood, we expect to be able to use these data to develop informatics tools that can model the absorption of drugs in the future, rather than requiring the drugs to be tested on live dog.”
The new model will not only seek to set a non-animal based data generation pathway, but also reduce or eliminate certain research practices, such as artificial infections of gastrointestinal parasites in animals that are then euthanized to evaluate whether a new drug was effective.
“While we understand that in certain situations the use of animals in research is needed, we’re committed to exploring ways to help FDA scientists and product developers reduce reliance on this practice,” Gottlieb said. “This proposed study is a big part of that effort.”
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email firstname.lastname@example.org for more information.
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