REPEATED DOSE TOXICITY
Altasciences’ unique composition of toxicologists and clinicians allows you to leverage both preclinical and clinical perspectives as we design these GLP, first-in-human-enabling studies. 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 studies usually range from 2 to 6 weeks. Identifying biomarkers and other key translational endpoints on these studies prior to entering the clinic could be beneficial and help reduce risk.
Our team of scientists is well poised to help collaborate on the general principles and designs of these studies, 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 laboratory services, which offer you the scientific rigor that is required. Studies are performed under Good Laboratory Practices 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 support research services and bioanalytical expertise.
Please see Therapeutic Areas for a fuller discussion of our capabilities and expertise.