The primary objective of Pharmacokinetic/Pharmacodynamic (PK/PD) modelling is the prediction of the time course of the drug effect and its relation to dose and exposure. PK/PD modelling has become a key success factor in drug research & development. 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 modelling is part of pharmacometrics and can be based also on the patho-physiological mechanisms and progression of the disease to predict therapeutic effects.
The PK/PD in Streamlining Drug Development Masterclass is a comprehensive and detailed two-day course which 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 but also for those who wish to get an 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 and Clinical PK/PD studies including the role of radiolabelled studies and the evaluation of pharmacologically active and/or toxic metabolites and toxicokinetics will be described.
The dose-exposure-effects will be explained through physiologically - and mechanism-based PK/PD modelling to design first-in human and later clinical trials. Clockwise and counter-clockwise hysteresis as common forms of PK/PD correlations will be covered 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 microdosing as regulatory requirements and tools for a correct design and conduction of early clinical trials, will be explained.
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 an NCE 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 mathematics. The course will provide trouble-shooting strategies for all the main studies and will focus on the critical aspect for a smooth conduction, interpretation, and use of PK/PD for the successful selection and registration of new Chemical and Biological Entities.
The PK/PD in Streamlining Drug Development Masterclass is a comprehensive and detailed two-day course which 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 but also for those who wish to get an 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 and Clinical PK/PD studies including the role of radiolabelled studies and the evaluation of pharmacologically active and/or toxic metabolites and toxicokinetics will be described.
The dose-exposure-effects will be explained through physiologically - and mechanism-based PK/PD modelling to design first-in human and later clinical trials. Clockwise and counter-clockwise hysteresis as common forms of PK/PD correlations will be covered 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 microdosing as regulatory requirements and tools for a correct design and conduction of early clinical trials, will be explained.
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 an NCE 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 mathematics. The course will provide trouble-shooting strategies for all the main studies and will focus on the critical aspect for a smooth conduction, interpretation, and use of PK/PD for the successful selection and registration of new Chemical and Biological Entities.
