Toxicity studies during drug development are essential. They play a vital role in helping drug sponsors make informed decisions. Your organization wants tests supporting data-driven decision-making to help move your drug development further along toward manufacturing and clinical trials. Your CRO partner can leverage the preclinical data in planning for and designing your first in human clinical trials. Here are six things you need to know before starting repeat-dose toxicity testing.
How Long Does a Repeated-Dose Toxicity Test Take?
Once the design of the repeated-dose toxicity test is finalized, the tests usually range from 2 to 6 weeks. Using bioanalysis to identify biomarkers and other key translational endpoints during preclinical toxicology studies can help reduce the risk to clinical study participants and greatly benefit your research. It helps to have a team well-versed in selecting species, treatment group size, frequency, duration of treatment, administration route, in-life observations, and terminal endpoints based on the properties of your intended clinical use.
What Is the Goal of the Tests?
When performing toxicity testing, the goal is to identify possible adverse effects of exposure to a test article. This develops dose-response relationships which, in turn, provide relevant information about the severity of effects occurring with exposure. This can be used to predict the effects on human populations. If you are teaming up with a CRO, find one that follows Good Laboratory Practices (GLP). These standard regulatory programs help ensure quality, consistency of format, and the integrity of nonclinical safety test data when submitted for new drug approval to worldwide regulatory agencies.
What Do Tests Look for?
Repeated-dose toxicity tests look for potential adverse effects with repeated doses of your test article over a period of time. The tests can help determine the maximum dose that can be given over a specified period without compromising the survival of the test models. This information is critical for determining dose ranges when it comes time to perform first-in-human trials.
What Are Some of the Common Tests Performed?
The two most common tests are the Ames and hERG tests. The Ames tests looks for mutations in DNA. The hERG test checks for cardiac abnormalities. Both can provide valuable data that helps you make decisions in subsequent stages of your project.
What Other Toxicity Testing Is Part of Drug Submission?
Sub-chronic and chronic toxicity tests may be needed as part of a new drug submission. They are used to test drugs that may be used on human participants on a long-term basis. Much like repeat-dose toxicity study designs, longer chronic and sub-chronic studies are used to further test any hypotheses of mode of action. They are useful for predicting the health effects of your test article in human exposure, further characterizing the dose-response relationship, identifying target organs, and identifying a dose level that does not demonstrate adverse effects.
Finding a Partner for Repeated-Dose Toxicity Tests
If you are looking for a partner to run toxicity tests, your organization will want a CRO that adheres to GLP practices. Having toxicologists and clinicians can help your organization leverage both preclinical and clinical perspectives while designing GLP repeated-dose toxicity tests that enable first-in-human tests. Ideally, reports should be prepared SEND-ready to help facilitate your submission to any regulatory agencies.
Altasciences, a mid-sized contract research organization, understands drug development is a complex process. Their fully integrated team helps keep their sponsors’ clinical research projects smooth and streamlined. Altasciences is a fully integrated CRO with pharmaceutical CDMO capabilities, and all their teams share access to a proprietary database. Pharmaceutical and biotechnology companies of all sizes count on Altasciences’ innovative, integrated approach for preclinical studies and clinical trials. Partnering with the Altasciences team means you gain expertise in a wide variety of therapeutic indications and study types, including first-in-human clinical trials and CNS clinical trials.
Partner with Altasciences for repeated-dose toxicity testing at https://www.altasciences.com/
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