Sub-Chronic/Chronic, Repeated Dose Toxicity
Sub-chronic/chronic, repeated dose toxicity studies can clarify long-term effects of your therapeutic entity and support its continued clinical development and marketing.
Such studies vary in length, typically ranging from 3 to 12 months, and are usually conducted in one rodent and one non-rodent species. Similar to shorter repeated dose toxicity study designs, the purpose of these longer studies is to further test the hypotheses regarding mode of action, predict the health effects of your therapeutic entity in human exposure, identify target organs, further characterize the dose-response relationship, and identify a dose level that does not demonstrate adverse effects.
At Altasciences, we understand that these studies provide conclusions about the long-term effects of a test substance in animals and humans. Accordingly, it is our objective to always provide the most comprehensive and regulatory-compliant reports to better support your clinical trials in humans.
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.