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Pharmacokinetic and Pharmacodynamic Modelling: an Overview for Medical Writers

Level:
Advanced
Area:
Drug Development
Code:
DDA19
Duration:
03:30:00
Workshop profile:
Participants should be familiar with the drug development process and have an understanding of basic pharmacokinetics.
Objective:
After completing the workshop, participants will have an understanding of the strategic role PK/PD modelling plays in drug development. In addition, they will gain an appreciation of how modelling can influence the claims that can be made on the drug label. They will be better placed to discuss modelling issues within projects, and to incorporate modelling outcomes into reports and regulatory documents.
Content:
The rationale for modelling in drug development is presented, along with the regulatory view. Different modelling techniques (compartmental, population, pharmacokinetic/pharmacodynamic [PK/PD], physiologically based (PBPK) are discussed in terms of their principles, their role within a drug development programme, and common terms used in their execution. This is illustrated with examples from the literature and the presenter’s personal experience.  How modelling output can influence the claims made on the drug label will be discussed. The workshop consists of modules interspersed with individual and group learning tasks.