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Release date: July 1, 2007
Available for credit through: July 1, 2009

Program Description

Bioequivalence is a comparison of two or more products with respect to their bioavailabilities. Bioequivalence of trade and generic products or different dosage forms of the same product needs to be determined before the products can be legally interchanged. Numerous factors can affect bioavailability (and bioequivalence) determinations. Patient factors include variations in absorption power and the pH (or acidity) of the gastrointestinal (GI) tract, gastric emptying rate, intestinal motility, GI tract perfusion, first-pass drug metabolism, age, sex, weight, disease status and interactions with other substances including drugs and rather common food. Thus, there is a great potential for wide variability among the pharmacokinetic profiles among patient populations and bioequivalence determinations. As pharmacists and nurses, we are in an optimal position to prevent or intervene when a patient is experiencing drug-drug and drug-food interaction resulting in bioavailability alterations with outcomes including sub-therapeutic responses or adverse events. While product interchange between trade and generic medications or between dosage forms of the same product is typically not a problem, this activity is going to highlight some examples of when it is a concern.

Target Audience

This activity is intended for nurses and pharmacists.

Educational Objectives

Upon completion of this educational activity participants will be able to:

  • Distinguish the differences between bioequivalence and bioavailability
  • Understand how factors related to the dosage form and patient variables affect drug stability, dissolution capacity, and absorption properties
  • Recognize problems that arise with bioequivalence and generic substitution
  • Learn which critical patient and disease factors require special consideration for product selection

Disclaimer

©2007 ArcMesa Educators, LLC / CMEdiscovery.com. All rights reserved. None of the contents may be reproduced in any form without prior written permission from ArcMesa Educators, LLC.

The views and opinions expressed in this activity are those of the faculty. They do not reflect the views of Acorda Therapeutics, any other manufacturer of pharmaceuticals or ArcMesa Educators, LLC.

The recommendations made in this program are based upon a combination of randomized clinical trials, current guidelines, and the clinical practice experience of the participating panelists. Any medications, diagnostic procedures or treatments discussed by the panelists should not be utilized without evaluation of their patient's conditions. Participants are urged to consult the full prescribing information on any drug mentioned in this activity for recommended dosage, indications, contraindications, warnings, precautions, and adverse effects before prescribing any medication.





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CMEdiscovery.com
Copyright © 2006 ArcMesa Educators / CMEdiscovery.com. All rights reserved.
Andrew J. Pultz, Jr., PharmD., R.Ph.
Andrew J. Pultz, Jr, PharmD, RPh
Specialty Practice Pharmacist
The Ohio State University Medical Center

Joseph Dasta
Joseph F. Dasta, MSc, FCCM, FCCP
Professor
Division of Pharmacy Practice and Administration
College of Pharmacy
The Ohio State University

Sandra Kane-Gill
Sandra L. Kane-Gill, PharmD, MSc
Assistant Professor
Pharmacy and Therapeutics
University of Pittsburgh