Eleftheria Tsakalozou, PhD

Lead Pharmacologist, Division of Quantitative Methods and Modeling, Office of Generic Drugs
US FDA
Silver Spring, Maryland, United States

Eleftheria Tsakalozou, PhD (Lead Pharmacologist, US Food and Drug Administration (FDA)) obtained her Ph.D. in Pharmaceutical Sciences at the University of Kentucky in 2013 and completed a two-year Fellowship in Clinical Pharmacokinetics and Pharmacodynamics at the University of North Carolina at Chapel Hill before joining the FDA in 2015 as an Oak Ridge Institute for Science and Education (ORISE) Fellow. She is currently a Lead Pharmacologist at the Division of Quantitative Methods and Modeling at the Office of Research and Standards with expertise on physiologically based pharmacokinetic modeling and simulation approaches for topical and transdermal drug products. She is supporting a team focused on the development and regulatory application of mechanistic modeling and simulation tools to support virtual bioequivalence assessments for non-orally administered.

Disclosure information not submitted.

Presentation(s):

• FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

  Tuesday, October 21, 2025
  1:45 PM - 3:15 PM MDT

• The Development and Framework of MMF as a Regulatory Initiative.

  Tuesday, October 21, 2025
  1:45 PM - 2:05 PM MDT

• Panel - FDA’s Model Master Files: Paving the Path for Innovative Technologies and Increased Regulatory Acceptance of Modeling and Simulation Approaches

  Tuesday, October 21, 2025
  3:05 PM - 3:15 PM MDT