United Pharmaceuticals Inc. conducts tailored dose optimization studies, including dose range-finding (DRF) and maximum tolerated dose (MTD) evaluations, to support early safety decision-making across diverse therapeutic areas. With decades of preclinical experience and thousands of studies completed, our teams generate dependable data to strengthen IND submissions. Identifying an appropriate dosing window is a critical step in preclinical development. Our DRF and MTD studies define suitable exposure levels for subsequent GLP toxicology studies, helping ensure compounds are positioned for safe assessment before entering first-in-human trials.
Reach out to connect with a team of experts and design a DRF or MTD study aligned with your development goals, timelines, and regulatory expectations.
Dose range assessment studies play a foundational role during early-phase development by serving two primary objectives. First, they establish an appropriate dosing window by identifying tolerated exposure limits and potential efficacy thresholds to guide future studies. Second, they generate critical dose-related data that inform study design, scheduling, and risk-mitigation strategies. This structured approach supports ethical study planning while maximizing scientific value.
Our toxicology specialists routinely perform initial in vivo assessments to evaluate dosing levels, administration frequency, and delivery routes appropriate for each compound. Flexible study designs allow our scientists to adapt protocols based on emerging data and program-specific requirements, ensuring optimal dose selection for downstream development activities.
Selecting the appropriate route of administration is essential for generating safety data that can be reliably translated into clinical development. Routes are selected based on compound characteristics, intended human use, and specific study objectives. In some programs, evaluating more than one administration route provides broader insight into exposure and tolerability, helping reduce development risk.
Our toxicologists guide dosing route decisions to ensure alignment with scientific rationale and regulatory expectations.
Dose optimization studies include a focused set of evaluations designed to identify dose-related trends and early signs of toxicity. These assessments help characterize compound safety while supporting efficient study design for subsequent development phases.
When required, additional specialized evaluations—such as ocular or developmental and reproductive toxicity studies—are incorporated based on the compound’s risk profile. All assessments are tailored to the specific properties and intended application of the test article, ensuring scientifically sound and decision-ready data.