Nonclinical pharmacokinetic/pharmacodynamic (PK/PD) modeling and simulation are key strategies in the early stages of new drug development to enhance the probability of success. Drawing on extensive experience, we go beyond simple analysis of nonclinical data to examine the complex relationships between a drug’s pharmacokinetics (PK) and its pharmacodynamic (PD) effects.

C&R Research integrates in vitro and in vivo data obtained from nonclinical studies to accurately model the Absorption, Distribution, Metabolism, and Excretion (ADME) properties of a drug. Through this process, we predict changes in drug concentration within the body and quantitatively correlate pharmacological responses observed at specific drug concentration levels.

In addition, nonclinical PK/PD modeling is utilized to virtually evaluate various study design scenarios. This enables the prediction of optimal sampling time points, dosing intervals, and dose ranges before conducting actual clinical trials, thereby reducing unnecessary trial-and-error and enabling efficient allocation of research resources. This model-informed drug discovery and development (MIDD) approach also contributes to predicting potential drug toxicity and adverse effects in advance, while optimizing safety. Ultimately, nonclinical PK/PD modeling and simulation maximize efficiency in the early development phase and provide a solid scientific foundation for a successful transition to clinical trials.

We integrate pharmacokinetic (PK) and pharmacodynamic (PD) analyses across all stages of drug development, from nonclinical data analysis to clinical trial design and regulatory submissions. Through nonclinical PK/PD modeling, we elucidate the relationships between a drug’s pharmacokinetics and pharmacodynamic effects, enabling precise prediction of the First-In-Human (FIH) dose to ensure the safety and efficiency of early clinical trials. Furthermore, by employing population PK/PD modeling and simulation, we analyze patient-specific drug responses, establish optimal dose-response relationships, and propose personalized treatment strategies tailored to individual patients.

By simulating various scenarios, we derive the most efficient and successful clinical trial designs, thereby reducing unnecessary trial-and-error. We quantitatively demonstrate a drug’s efficacy and safety profile, and prepare professional reports in compliance with regulatory guidelines to help expedite the new drug approval process. Leveraging data-driven insights, we eliminate uncertainties in drug development, optimize clinical trial design, and establish a robust scientific foundation for the successful market launch of new therapies.