Who will benefit from this module?
Pharmacologists, nonclinical and clinical researchers, and others involved in drug development will find this module an accessible, concise account of the relevance of PK & PD in the registration of drugs for human use. A basic knowledge of the terminology of PK and PD is assumed.
- Explain the role of PK/PD studies in modern drug development and registration.
- Describe the use of PK/PD data from preclinical and clinical studies.
- Recognise the role of PK parameters in special population studies.
- Identify the processes used to obtain PK/PD data from nonclinical and clinical trials.
- Describe the PK/PD factors underpinning the concepts of bioavailability and bioequivalence.
CPD Points: 3.5
Assessment: Multiple-choice mastery assessment
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.