Using Pharmacokinetics and Pharmacodynamics Principles to enable IND and NDA Submissions

Venue: Hyatt Regency Bethesda

Location: Bethesda, Maryland, United States

Event Date/Time: Apr 16, 2012 End Date/Time: Apr 17, 2012
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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 successully 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

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.

Learning Objectives:

At the conclusion of this activity, participants 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

Target Audience:

Professionals involved in:

• Regulatory Affairs

• Clinical Research

• Clinical Pharmacology

• Pharmacokinetics/pharmadynamics

· This course will also be valuable for FDA reviewers and other FDA staff.

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