Rachel Tapp discusses ototoxicity study designs for drugs with ototoxic potential and how Charles River can support these preclinical studies.
Rachel Tapp (00:09):
I'm Rachel Tapp, Senior Study Director here at Charles River Laboratories, working in the neuro behavioral sciences group, focusing in ototoxicity. Our ototoxicity services are really broad. We have developed quite a few end points that are required for these types of studies. It gives us a lot of historical data to compare against and a lot of confidence in what we're actually seeing, the changes that happen with positive controls.
There's definitely a lot of development required for this type of study. You have to understand the dynamic of how you need to run the study. You need to understand the endpoints that are required. And you need to understand how to apply those endpoints effectively. The work that we do here is vital across all different areas of research. What I specifically do is ensure that a drug is either going to work in a disease or potentially will work in to disease or is safe for someone to be administered.
We have the capability here to test drugs that are known, that are going in the ear, or that have a risk that we need to assess. We are going to be helping those clients still. But in addition, we'll be able to offer to clients that have compounds in a class of risk, like amino glycosides or loop diuretics or heavy metals, those types of compounds, though they're not directly administered to the ear every time, they potentially can have a risk for ototoxicity.
A client has an opportunity now to say, "This is my drug. This is the class that it's in. It's likely that I'm going to need to do this type of work, or I want to answer that question before in human or if they're in the clinic", and they say, "Oh, we have clients complaining of this change in their hearing, or vestibular function or things like that." They can come back to us and we can help try to assess that for them.