Pharmacokinetics and Pharmacodynamics in Drug Registration

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.

• Defining PK/PD
• Role and relevance of PK/PD in drug registrations
• PK/PD data for new or generic drug safety profiles

• Pharmacologists
• 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