The Practical and Regulatory Perspective of Bioequivalence

• Distinguish the difference between bioequivalence, bioavailability and therapeutic interchange
• Describe how to obtain drug information concerning bioequivalence
• Evaluate how factors such as dosage form, drug-drug and food-drug interactions affect the bioequivalence of a drug
• Describe the regulatory issues associated with drug substitution

Sandra L. Kane-Gill, PharmD, MSc Sandra L. Kane-Gill, PharmD, MSC received her baccalaureate pharmacy degree from Wayne State University in 1994.  She completed an ASHP accredited pharmacy practice residency at West Virginia University Hospital in 1996.  In 1998, she received her Doctorate of Pharmacy from the University of Toledo.  Dr. Kane-Gill then pursued her Masters of Science in Pharmacy Administration with emphasis on Pharmacoeconomics and Health Outcomes at the Ohio State University in Columbus, Ohio from 1999-2001.  Between 1998-2001, she completed her Critical Care Fellowship at the Ohio State University.  Upon completion of her training, she joined the faculty of the University of Pittsburgh, School of Pharmacy in 2001 with an appointment as Assistant Professor in the Department of Pharmacy and Therapeutics for the Center for Pharmacoinformatics and Outcomes Research.

Dr. Kane-Gill’s research interests focus on economic, clinical and humanistic evaluations for critically ill patients; specifically patient safety, quality of life in patients receiving sedatives/neuromuscular blockers, and developing models of cost for acute illness.  She has served as Principal Investigator and Co-Investigator on several funded research grants in this area of study.  Her research projects spanned the areas of anticoagulation, infectious disease, antidysrhythmics, sedation and adverse drug events.  Her work has been presented as both oral and poster presentations at several national and international professional meetings including the Society of Critical Care Medicine (SCCM), European Society of Intensive Care Medicine, Annual American Society of Health-System Pharmacists (ASHP), American College of Clinical Pharmacy (ACCP, as well as local professional meetings.  She has published over 30 abstracts and 20 peer-reviewed manuscripts.     Dr. Kane-Gill is very involved in national and international organizations through active membership in ACCP, SCCM, ASHP, International Society for Pharmacoeconomics and Outcomes Research.  Currently she holds the appointment of past-chair for the Clinical Pharmacy and Pharmacology Section of SCCM.  Also, she has recently been elected as a member of the United States Pharmacopeia Therapeutic Decision Making Expert Committee.

Joseph F. Dasta, MSc, FCCM, FCCP Joseph F. Dasta, MS, FCCM, FCCP, received his BS in Pharmacy in 1974 from West Virginia University and MS in Hospital Pharmacy in 1976 from The Ohio State University.   He is a professor of pharmacy at The Ohio State University in Columbus, OH.  He has been a teacher, researcher and critical care pharmacy practitioner for 30 years and established one of the first practice sites and residencies in critical care pharmacy.  He is a fellow in the American College of Clinical Pharmacy and the American College of Critical Care Medicine.

Professor Dasta has written over 200 articles, abstracts, and book chapters and has given nearly 200 invited presentations in the area of acute care pharmacotherapy and pharmacoeconomics.  He is a member of the Editorial Board, Critical Care Medicine and Annals of Pharmacotherapy. He was recently honored by SCCM in having a pharmacy outcomes research grant in his name and received the 2002 Education Award from the American College of Clinical Pharmacy.  Current research interests include: Pharmacoeconomics and outcomes of sedatives, vasopressors, parenteral antihypertensives, anemia management, sepsis therapies, adverse drug events in the ICU, and developing models of the cost of acute renal failure and CHF.

Nicholas M. Fleischer, RPh, PhD Nicholas M. Fleischer, R.Ph., PhD., joined THE WEINBERG GROUP in 1997 and has 19 years of experience in biopharmaceutics and pharmacokinetics.  Prior to joining THE WEINBERG GROUP, Dr. Fleischer held several positions at the United States Food and Drug Administration (FDA), the most recent being Director of the Division of Bioequivalence, Office of Generic Drugs, Center for Drug Evaluation and Research (CDER).

Prior to joining the FDA, Dr. Fleischer was Deputy Chief, Assistant Chief, and Director of Quality control in the Pharmacy Department of the United States Public Health Service Hospital, Staten Island, New York.  He received his Ph.D. in Pharmacology from the Uniformed Services University of the Health Sciences, a M.S. in Hospital Pharmacy Administration from the Long Island University, and a B.S. in Pharmacy from the Massachusetts College of Pharmacy.

Mary Lea Gora-Harper, PharmD, FASHP Mary Lea Gora-Harper is currently a private consultant in the area of medication information and policy development, and is an associate professor at the University of Kentucky College of Pharmacy in Lexington.  She received her B.S. and Pharm.D. degrees from Purdue University School of Pharmacy in West Lafayette, Indiana. She completed a residency and fellowship in drug information at The Ohio State University College of Pharmacy and Hospitals in Columbus. She was Director of Drug Information at the University of Cincinnati before joining the University of Kentucky faculty in 1991.

Dr. Gora-Harper is active in several professional societies including the American Society of Health-System Pharmacists (ASHP ) and the American College of Clinical Pharmacy (ACCP). She has served on the board of directors for the ASHP Section of Clinical Specialists, and chaired the ASHP Commission on Therapeutics. She has also served as ASHP network facilitator (drug information/pharmacoeconomics), committee member for public policy in the Section for Clinical Specialists, project coordinator for therapeutic guideline development, a member of the practice interest advisory panel, meeting program associate, Kentucky state delegate, and a presenter. She was President for the KSHP, as well as serving other roles including  KSHP regional delegate and newsletter editor. She is one of the founding members of the Consortium of Medication Information, Policy,  and Research.  Dr. Gora-Harper’s research and publications have been directed toward therapeutic guideline development, outcomes research, and information systems.  She serves as reviewer, column editor, or editorial board member for several scientific journals including the Annals of Pharmacotherapy, Pharmacotherapy, and the American Journal of Health-System Pharmacists. She is author of several book chapters related to these topics, and is author of the Compendium of Injectable Drugs.