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Repeat-Dose Toxicity Testing

Altasciences' demonstrated expertise in repeated dose toxicity tests ensures that you have the robust safety testing data to advance your program. Toxicity studies in clinical trials have a vital role in informing crucial development decisions, and our repeat dose toxicity experience supports data-driven decision-making.

Our unique composition of toxicologists and clinicians allows you to leverage both preclinical and clinical perspectives as we design GLP, first-in-human-enabling, repeated dose toxicity tests. Our design of repeated dose toxicity studies is based on available PD, PK, and toxicological information from previous studies as well as the intended clinical use.

Repeated dose toxicity tests usually range from 2 to 6 weeks. Identifying biomarkers and other key translational endpoints on these preclinical toxicology studies prior to entering the clinic could be beneficial and help reduce risk.

Our team of safety testing experts is well poised to help collaborate on the general principles and designs of your repeat dose toxicity tests, including the selection of species, treatment group size, duration of treatment, frequency, and route of administration, as well as relevant in-life observations and terminal endpoints based on the properties of your test article and intended clinical use.

Inclusion of specialized endpoints based on the pharmacology of your test article is also available through our toxicology laboratory services. Repeated dose toxicity tests are performed under Good Laboratory Practices (GLP), and reports are prepared SEND-ready in order to facilitate your submission to regulatory agencies.

REPEAT DOSE TOXICITY - FAQs

What are the goals of GLP toxicology safety testing?

The goals of toxicity testing are to identify possible adverse effects of exposure to the test article, to develop dose-response relationships that can provide important information about the severity of effects occurring with exposure, and ultimately to predict the effects of exposure of human populations. Repeated dose toxicity. Good Laboratory Practices (GLP) are standard regulatory programs that ensure the quality, consistency of format, and integrity of nonclinical safety test data submitted for new drug approval to regulatory agencies worldwide.

What do repeated dose toxicity and maximum tolerated dose testing look for?

Repeated dose toxicity tests are used to determine the potential adverse effects of repeated, dosing of your test article over a period of time. The maximum tolerated dose is the maximum dose that can be given over a specified study period that will not compromise the survival of the test animals. Information from both the repeated dose toxicity test and maximum tolerated dose test is critical for determining dose ranges for human testing.

What are some of the common tests performed?

Two of the most common are the Ames test, which looks for mutations in DNA, and the hERG test, which checks for cardiac abnormalities.

What other toxicity testing is part of a new drug submission?

Sub-chronic and chronic toxicity studies are used to test drugs that will be used by human patients on a long-term basis. Similar to repeated dose toxicity study designs, the purpose of longer chronic and sub-chronic studies is to further test the hypotheses regarding mode of action, predict the health effects of your test article in human exposure, identify target organs, further characterize the dose-response relationship, and identify a dose level that does not demonstrate adverse effects.

THERAPEUTIC AREAS

Our deep expertise and capabilities in a broad range of therapeutic areas encompasses preclinical and early clinical studies for both small molecules and biologics. We can manage your entire program, as well as provide comprehensive support research services and bioanalytical expertise.

 

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Working as a flexible, attentive extension of your team, we offer comprehensive drug development services to move your molecule forward.

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