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.
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.