Our DRF/MTD studies are designed to provide, quickly and accurately, a quality toxicological and toxicokinetic assessment of potential new chemical entities early in your drug development process — facilitating conduct of subsequent regulatory toxicological studies and potentially earlier entry into clinical trials.
We provide flexible study designs for defining doses that can be used on future studies. During tolerance evaluations, compounds are first assessed in a single-dose escalation phase where the test system receives a single dose anticipated to achieve relevant multiples of the efficacious dose. Data from this phase evaluates absorption, and assists in estimating the maximum tolerated dose for a single administration and in establishing doses for a repeat dose phase. Studies of varied design, either single or multiple doses, may elicit dose-limiting signs of toxicity and allow selection of dose levels for regulatory studies.
At Altasciences, our team of toxicologists routinely performs preliminary toxicity studies in vivo to determine appropriate dosage, frequency, and route of administration. Our team has extensive knowledge and experience to help you determine maximum tolerable dose for your novel compounds for single and multiple dosing.
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.