SC01Pharmacokinetics and Pharmacodynamics in Drug Registration

Orientation – Designed as an introduction to using the Zenosis modules, this session guides you through the different functions of the module interface – such as how to navigate and interact with the course material. Also provided are five short tips on how to get the most from your e-learning experience.

PK/PD role and relevance – The role and relevance of PK and PD in the registration of new and generic drugs is described. The emerging trend towards formal standardisation of PK studies is discussed.

PK/PD studies in drug development – The role of PK/PD studies in nonclinical and clinical studies is explained. Study designs are discussed. Bioavailability, ADME and toxicokinetic studies are described. A variety of clinical studies are outlined in the context of PK.

Drug administration routes – Time-concentration curves for various routes of administration are compared. Prediction of the best route, on the basis of PK data, is discussed.

PD for drug registration – The distinction between PD effects and clinical outcomes is explained. Examples of dose-response curves and their interpretations are given. The importance of dose-response relationships in clinical trials and drug registration is discussed.

Sampling practice and outcomes – Common PK variables derived from sampling are described. Good sampling practice is discussed.

Data analysis – Compartmental and non-compartmental analysis are compared. Uses of AUC and volume of distribution are described.

Special populations – Requirements for studies in populations such as those with liver or kidney dysfunction are described.

Generics and bioequivalence – The principles and practice of bioequivalence studies for the registration of generic products are described.

Assessment – Multiple-choice mastery assessment.