PK/PD Studies in Drug Discovery and Development

Overview

PK/PD studies construct, validate, and utilize disease models, drug exposure-response models, and pharmacometric models to facilitate drug development. PK/PD studies offer great support to learn and confirm the key characteristics of new molecular entities in a quantitative manner. This provides evidences for optimizing drug development plans and enabling critical decision-making. Drug development without PK/PD modelling is considered at a higher risk of failure.

The webinar reviews the general concepts and basic elements of pharmacokinetics, pharmacodynamics, and their correlation. The use of PK/PD for dose selection during drug development will be described also with the presentation of a case study. The use of PK/PD will be described for the evaluation of both drug efficacy and safety. This will illustrate how the model-based drug development and, in particular, PK/PD studies, can facilitate knowledge management and decision making to streamline drug discovery and development and to reduce the attrition rate.

Webinar Takeaway

• Absorption
• Distribution
• Metabolism
• Excretion
• Drug action
• Dose-response relationship
• Selectivity
• Therapeutic window
• Biomarkers
• Variation in response
• Hysteresis
• Case study

Who Will Benefit

• Project managers
• Pre-clinical and clinical pharmacologists
• Regulatory affairs
• Clinical research associates
• Drug discovery scientists