Proposed FDA study will allow adoption, not euthanasia, of research dogs

The U.S. Food and Drug Administration (FDA) recently released proposed research aiming to validate an alternative approach to bioequivalence studies for certain animal drugs. This would eliminate the need to use and later euthanize dogs in certain types of research, according to a release from the FDA.

The proposed study will collect blood samples from dogs that have been given two common antiparasitic drugs-ivermectin and praziquantel-to compare their bioequivalence. Ivermectin, which is used to treat heartworm, and praziquantel, a treatment for tapeworms, act both locally and systemically. According to the release, bioequivalence studies of antiparasitic drugs that act locally within the gastrointestinal tract have historically ended in euthanasia.

In this study, however, the bioequivalence of ivermectin and praziquantel will be measured by “in vitro dissolution compared to blood levels that indicate how the drug is dissolving in the body (also known as blood-level pharmacokinetics), with the goal of validating these laboratory-based alternative (i.e. surrogate) endpoints,” the release states.

None of the dogs in the study will be artificially infected, and they will receive regular preventive veterinary care until they are retired for adoption once the research concludes. The dogs will also undergo two months of socialization with FDA animal care staff before the study begins to get them used to being handled.

If the findings support the researchers' current hypothesis, the data will be made public so animal drug sponsors can apply it in designing in vitro studies, thus eliminating the need for animal subjects in some research. 

To read the white paper, click here.

The FDA is currently accepting public comments on the proposed study. To submit your comments, visit regulations.gov and type FDA-2018-N-3345 in the search box.