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Using Pharmacokinetic and Pharmacodynamic Principles to Enable IND and NDA Submissions

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Overview 

When it comes to submitting an IND or NDA to the FDA, there are many scientific criteria that need to be met as well as a thorough understanding of clinical pharmacology and pharmacokinetic concepts and regulatory requirements. The agenda for this course is structured based on the building blocks for the Clinical Pharmacology reviewing discipline and associated FDA guidelines. This course brings together faculty from both industry and FDA to share strategies for compliance with biopharmaceutic and pharmacokinetic requirements to successfully file an IND and NDA. This course will allow ample time for questions and interaction with industry and FDA representatives.

What You Will Learn 

  • Bioanalytical requirements
  • Biopharmaceutics considerations
  • Bioequivalence guidance
  • Metabolic and transporter phenotyping
  • Clinical drug-drug interaction assessments
  • Pharmacogenomics principles
  • Pharmacokinetics in special populations
  • Pharmacometrics applications
  • Unique PK-PD aspects of biologics
  • QTc timing and impact

Who Should Attend 

Professionals involved in:

  • Regulatory affairs
  • Clinical research
  • Clinical pharmacology
  • Pharmacokinetics/pharmacodynamics
  • This course will also be valuable for FDA reviewers and other FDA staff

Learning Objectives 

Participants who complete this training should be able to:

  • Identify the biopharmaceutic and pharmacokinetic requirements needed to successfully file an IND and NDA submission
  • Define pharmacokinetic parameters to report study outcomes
  • Recognize the importance of the bioequivalence data analysis
  • Differentiate biologics from small molecules in drug development
  • Describe the value of pharmacogenomics and pharmacometrics in regulatory applications

Contact Information 

Jessica McGrory at +1-215-442-6182 or Jessica.McGrory@diahome.org

 

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