PK/PD studies construct, validate, and utilize disease models, drug exposure-response models, and pharmacometrics 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 evidence 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
Speakers
Dr. Stefano Persiani,
Rottapharm BiotechDr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA, and later as a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology
Who Should Attend
- Project managers
- Pre-clinical and clinical pharmacologists
- Regulatory affairs
- Clinical research associates
- Drug discovery scientists
