Principles and Mechanisms of Pharmacokinetic Drug-Drug Interactions for Recently Approved Drugs

The goal of this course series is to provide pharmaceutical scientists with an in-depth understanding of the mechanisms of drug interactions, providing the basis for scientifically justified and clinically sound decisions to prevent or minimize drug interactions.

In this 5-session course, we will explore clinically significant pharmacokinetic drug-drug interactions (DDIs) observed with recently FDA approved drug therapies. The possible mechanisms (e.g., inhibition or induction of metabolizing enzymes and/or transporters, changes in drug absorption, pharmacogenetics, organ impairment) will be reviewed and potential clinical outcomes explained. Mitigation strategies to prevent or minimize the risk of DDIs will be discussed.

Jointly provided by:

University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics
University of Wisconsin-Madison School of Pharmacy, Division of Pharmacy Professional Development

Overview

Course Objectives

At the end of this course, students will be able to:

Understand the basic scientific principles of drug metabolism and drug transport and their roles in controlling drug exposure and pharmacokinetic drug-drug interactions;
Review the main mechanisms involved in pharmacokinetic drug-drug interactions;
Understand the concepts of marker, victim, and perpetrator drugs and know how to extrapolate the results of a marker study to common co-medications;
Know the categorization of clinical victim and perpetrator drugs sensitivity and potency (weak, moderate, or strong) and the impact on product labeling recommendations;
Describe common drug interactions with recently approved drug therapies;
Examine significant drug interactions observed during the drugs’ development and discuss likely mechanism(s) and possible clinical outcomes;
Apply mechanistic knowledge gained to predict and prevent drug interactions;
Identify relevant resources to develop a risk mitigation strategy.

Outline

Course Outline

Lecture 1	Basic Principles and Main Mechanisms of Pharmacokinetic Drug Interactions Speaker: Cathy Yeung, PharmD, PhD, MPH, Instructor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics This presentation will describe various aspects of pharmacokinetic (PK) related drug-drug interactions (DDI) including substrate sensitivity, precipitant potency, and the most relevant PK measurements for characterizing DDI. Many case examples will be used to illustrate these principles, and a high-level overview of the top 5 clinically significant drug interactions from recent FDA approvals will be presented.
Lecture 2	Drugs Recently Approved by FDA (2013-2017) - Metabolism-based Drug Interactions Speaker: Jingjing Yu, MD, PhD, Principal Investigator and Instructor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics This presentation will describe the major drug metabolizing enzymes and their contribution to DDI. Factors that affect metabolism-based DDI and the in vitro and in vivo methodologies to investigate them will be discussed. Clinically significant DDI due to the induction and inhibition of drug metabolizing enzymes for recently approved drugs will also be presented along with strategies to manage potential DDI risk.
Lecture 3	Drugs Recently Approved by FDA (2013-2017) - Transporter-based Drug Interactions Speaker: Jingjing Yu, MD, PhD This presentation will describe the major transporters involved in drug disposition and the mechanisms of transporter-based DDI. The interplay between transporters and drug metabolizing enzymes in the context of DDI will be examined. The challenges and clinical importance of identifying sensitive substrates and strong inhibitors of transporters will also be discussed.
Lecture 4	Drugs Recently Approved by the FDA (2013-2017) – Absorption-based Drug Interactions and Food-Effects Speaker: Jingjing Yu, MD, PhD The mechanisms of absorption-based DDI due to acid-reducing agents and food effects will be discussed. A framework for the evaluation of pH dependent DDI and examples using recently approved drugs will be presented. Guidelines for investigating food-effect are highlighted and examples using recent drug approval are given.
Lecture 5	Impact of Patient Factors: Pharmacogenetics, Organ Impairment, and Natural Product-Drug Interactions Speaker: Cathy Yeung, PharmD, PhD, MPH The concept of gene-drug interactions and their clinical relevance will be introduced. Examples of gene-drug interactions and strategies for managing risk will be discussed. Guidelines for conducting hepatic and renal impairment studies is presented along with several examples of the effects of organ impairment on PK for recently approved drugs. Lastly, an overview and examples of natural product-drug interactions will be provided.

Instructors

Cathy Yeung, PharmD, PhD, MPH, Instructor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics, Seattle, WA

Jingjing Yu, MD, PhD, Principal Investigator and Instructor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics, Seattle, WA

Planning Committee

Leslie Dickmann, PhD, MPH, Program Director, Division of Pharmacy Professional Development, UW-Madison School of Pharmacy, Madison, WI

Isabelle Ragueneau-Majlessi, MD, MS, Senior Advisor, University of Washington (UW) Drug Interaction Solutions, Department of Pharmaceutics, Seattle, WA

Program Coordinator

Leslie Dickmann, PhD, MPH

Division of Pharmacy Professional Development
777 Highland Avenue
Madison, WI 53705
(608) 262-2431 FAX
(608) 265-8249
ljdickmann@wisc.edu

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