PK/PD in Drug Development - India

Workshop Overview

PK/PD modeling has become a key success factor in drug R&D. PK/PD represents an extremely useful tool for the selection of drug candidates, their optimization, and for maximal exploitation of early clinical studies for an optimal design of pivotal Phase 3 trials. PK/PD relies on prior in vitro bioassays, animal, and early clinical studies. PK/PD modeling is part of pharmacometrics and can be based also on the patho-physiological mechanisms and progression of the disease to predict therapeutic effects.

This comprehensive and detailed two-day course describes the PK/PD studies from an industrial perspective to achieve a successful regulatory submission. The course is intended for those that have a previous background in PK/PD and for those who wish to get in-depth training in PK/PD whilst not being specialists in the field.

The course will provide a review of the PK processes and of PD studies from a pharmacological perspective. Preclinical PK/PD studies includes the critical issues in study design and interpretation, and the role of radio-labelled studies and the evaluation of pharmacologically active and/or toxic metabolites and toxicokinetics will be described.

Fundamentals of Pd will be explained with drug-receptor interaction and dose-response curve (potency/efficacy/therapeutic index and window). It will cover clockwise, and counterclockwise hysteresis as common forms of PK/PD correlations as well as the use of biomarkers to assess target occupancy and their difference from surrogate endpoints. The application of MRSD and MABEL approaches and micro-dosing as regulatory requirements and tools for a correct design and conduction of early clinical trials, will be explained.

Pk/Pd studies in Drug Development will cover PK, PD and their correlation and drug-exposure-effect continuum in drug R&D. The biological and advanced therapies are becoming more important, and the course will provide an overview of PK/PD studies for these new agents. The scientific background, study design, and data interpretation for population pharmacokinetics will be covered. Finally, the course will describe how the potential for a New Chemical Entity to exert drug-drug interaction is assessed in pre- and clinical development.

Attendance will provide an overview of the above topics including temporal placement throughout the drug R&D program. This will be done without excessive use of mathematical calculations. The course will provide trouble-shooting strategies for all the main studies and will focus on the critical aspect for smooth conduction, interpretation, and use of PK/PD for the successful selection and registration of New Chemical and Biological Entities