Maximum Tolerated Dose (MTD) studies are among one of the earliest opportunities to administer your compound to a living test system, in order to determine potential signs of toxicity. Establishing the largest amount of drug that can be safely administered is a key early milestone in the development process, and it is important you have a partner who can perform these studies quickly, efficiently, accurately and on budget. MTD studies are a pivotal step in determining dose levels for all future studies in your drug development program. The results of the MTD study can be a catalyst for your program to continue its advancement to dose range finding (DRF) studies, or they can produce a speed bump resulting in a re-evaluation of the development strategy if unexpected results occur. In either scenario, Attentive will be the partner to help guide you. The collective experience at Attentive will provide troubleshooting approaches geared towards determining whether a new formulation, species, or other study changes will improve the outcome of your MTD study.
From the start of your study design discussions with Attentive, you will be engaged with the entire staff, including the scientists and study directors, as part of our client-calibrated approach. Attentive has a simplified and streamlined process for the pre-study planning period. By enabling clients direct access to the scientific staff via teleconference, email, and virtual study monitoring, we ensure that the team is working on exactly what your MTD studies need at any given time.
While the name Attentive may be new, its team is not. The Attentive team has decades of experience fielding the unique challenges posed by new molecules. When your team brings a compound to Attentive, we will work together with you to build MTD designs that fit your unique needs. Our approach will bring our experienced scientists together with yours to determine how to move forward with specialized or unique compound requirements. In the rare instances that your needs are outside of our extensive knowledge base or site capabilities, we will guide you towards a reputable source that can meet your needs. Ultimately, we want you and your compound to succeed, beginning from the first time it is applied to a test system, through agency approval.
Sometimes it may be that the molecule or formulation isn’t quite ready for an MTD study. The Attentive team’s past experiences working at multiple CROs allows us to identify potential “pit-falls” early and present solutions to address them before it is too late. For example, we advised a client that their neat material did not appear suitable for the intended route of administration, and by conducting a simple feasibility study, we were able to confirm this and saved our client from going forward with additional (costly and time-consuming) studies.
Partnering with Attentive’s experienced scientific staff allows you to establish a maximum tolerated dose for your compound with confidence. Contact us to explore your options.