October 16, 2013
Faculty involved, pictured from left to right: Gregory Amidon, Vicki Ellingrod, Steven Schwendeman, Duxin Sun, Barry Bleske, Anna Schwendeman, Gordon Amidon.

This summer, the U.S. Food and Drug Administration (FDA) awarded $4.8 million in project funding to the University of Michigan College of Pharmacy. The FDA’s goal: To accelerate Agency efforts to develop the field of regulatory science, defined as the "science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA regulated products."

Our faculty’s success in obtaining these FDA funds not only affirms their scientific talent, but also their interest in having their research translated into drug product efficacy, safety, and quality. Equally significant is the fact that the interdisciplinary nature of the work being funded by the FDA encompasses every department at the College.

We have a proud history of collaboration with the FDA, most notably in the person of Charles R. Walgreen Jr. Professor of Pharmaceutical Sciences, Gordon Amidon, PhD. His partnership with the FDA resulted in the Biopharmaceutical Classification System (BCS), a significant achievement that helped advance the Agency’s mission to ensure safer, more affordable drug products in our nation’s marketplace.

It is my hope our research relationship will grow into more collaborative efforts that will strengthen our shared commitment to improve the health of our nation.

Frank J. Ascione, BSPharm’69, PharmD’73, PhD
Dean
University of Michigan College of Pharmacy

 

Accordion Row
  • Project 1

    PI: Duxin Sun, PhD, Professor of Pharmaceutical Sciences

    Title: Investigation of Inequivalence of Bupropion Hydrochloride Extended Release Tablets: In Vitro Metabolism Quantification 

  • Project 2

    PI: Duxin Sun, PhD, Professor of Pharmaceutical Sciences

    Other COP Investigators: Vicki Ellingrod, PharmD, Professor, CP, College of Pharmacy; and Associate Professor of Psychiatry, U-M Medical School; Rose Feng, PhD, Associate Research Scientist, Pharmaceutical Sciences

    Non-COP Investigators: Melvin McInnis, MD, UMHHC, Professor, Department of Psychiatry; and Director, Depression Center; Masoud Kamali, MD, Clinical Lecturer, Department of Psychiatry

    Title: Investigation of Release Profiles of Bupropion and Pharmacogenomics of Metabolism Enzymes for Bioequivalence of Generic Bupropion Products in Healthy Volunteers

  • Project 3

    PI: Steven P. Schwendeman, PhD, Ara G. Paul Professor and Chair, Department of Pharmaceutical Sciences

    Co-Investigators: Rose Feng, PhD, Associate Research Scientist, Pharmaceutical Sciences; Anna Schwendeman, PhD, Research Assistant Professor, Medicinal Chemistry, College of Pharmacy

    Title: In Vitro-In Vivo Correlations of Parenteral Microsphere Drug Products

  • Project 4

    PI of U-M Sub: Anna Schwendeman, PhD, Research Assistant Professor, Medicinal Chemistry, College of Pharmacy, (PI of Grant: Mark Eamon Hayes, PhD, at Zoneone Pharma, Inc.)

    Co-Investigators: Gregory Amidon, PhD, Research Professor, Pharmaceutical Sciences, College of Pharmacy, and Program Director for the Pharmaceutical Engineering Program, College of Engineering

    Title: Development of a Liposome Product Drug Release Assay

  • Project 5

    PI: Duxin Sun, PhD, Professor of Pharmaceutical Sciences

    Co-Investigators: Barry Bleske, PharmD, Associate Professor, CP

    Non-COP Investigators: William Hasler, MD, Professor of Internal Medicine, U-M Medical School

    Title: Correlation of Mesalamine Pharmacokinetics with Local Availability, Clinical Trial

  • Project 6

    PI of U-M Sub: Gordon Amidon, PhD, Charles R. Walgreen Jr. Professor of Pharmaceutical Sciences; Duxin Sun, PhD, Professor of Pharmaceutical Sciences

    Other COP Investigators: Gregory Amidon, PhD, Research Professor, Pharmaceutical Sciences, College of Pharmacy, and Program Director for the Pharmaceutical Engineering Program, College of Engineering

    Co-Investigators: William Hasler, MD, Professor of Internal Medicine, U-M Medical School; James Brasseur, PhD, Professor of Mechanical Engineering, Bionengineering, and Mathematics, Penn State University

    Title: Modernization of In Vivo-In Vitro Oral Bioperformance Prediction and Assessment