All new drugs entering development to treat human diseases (small or large molecules), must undergo a series of nonclinical investigations to examine their safety and efficacy. These studies are conducted to gain insights to support informed clinical development plans for their compound or biologic.
A primary goal of nonclinical studies is to understand how therapeutic and toxicological responses (that is, pharmacodynamic and toxicodynamic effects) are related to drug exposure by studying doses from sub-therapeutic to toxic-therapeutic. This provides a wide range of concentrations in biological matrices (such as blood and plasma) that may be correlated with pharmacodynamic and toxicodynamic effects to ultimately inform dosing considerations and safety margins as the drug progresses through the various phases of nonclinical and clinical development.
Allucent works with your team to craft and execute an expertly designed nonclinical program. This includes creating fit-for-purpose study designs and protocols and continues through robust analyses of study outcomes using complimentary approaches that convert data into knowledge that drives decision making. Additionally, our experts can be integrated into ongoing programs to evaluate regulatory feedback and provide a comprehensive assessment of the current nonclinical program, identify any gaps, and define an appropriate mitigation strategy that adequately addresses those gaps.
Nonclinical Strategy, Study Design, and Analysis Services:
- Nonclinical Development and Regulatory Strategy
- Gap Analysis
- Study Design and Protocol Development
- Data Analysis and Interpretation