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Pharmacokinetics and Pharmacodynamics in Drug Registration

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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 ZenosisĀ® 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

Contact Information 

Linda Belmont, DIA
Phone +

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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