Pharmacokinetic and pharmacodynamic (PK/PD) studies play a vital role in drug development. Regulatory authorities are placing greater emphasis on PK/PD in drug registration. This Zenosis® eLearning module helps learners understand the role of PK/PD data in establishing the safety profile of a new or generic product. Learners should have a basic knowledge of PK/PD terminology before taking this course.
The module takes an average of 3 hours to complete. (Note that this is an average time. People learn at different rates, and they explore resources and examples at different paces.)
- Defining PK/PD
- Role and relevance of PK/PD in drug registrations
- PK/PD data for new or generic drug safety profiles
Who should attend?
- Nonclinical and clinical researchers
- Drug development professionals and experts
Participants who complete this course should be able to:
- 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
- Recognize 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