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Pharmacokinetics and Pharmacodynamics in Drug Registration

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Overview 

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 +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$150.00
Register Online
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