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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 LeoPink Limited 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.)

Featured topics

  • 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?

  • Pharmacologists
  • Nonclinical and clinical researchers
  • Drug development professionals and experts

Learning objectives

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

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