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  The Practical and Regulatory Perspectives of Bioequivalence

This month’s feature CE program focuses on practical considerations of therapeutic medication interchange. Special attention is given to providing pharmacists with the knowledge and tools needed to make proper decisions regarding the appropriateness of substituting one medication for its bioequivalent alternative. It is essential to this process, to provide practitioners with adequate, unbiased and scientifically rigorous resources to obtain the latest drug and regulatory information regarding proper drug substitutions.

In order to distinguish when it is appropriate to make a bioequivalent substitution, pharmacists and pharmacy technicians must be able to clearly distinguish between bioequivalence, bioavailability and therapeutic interchange. Knowing where to obtain current, unbiased and accurate information concerning these decisions is of course, essential to making therapeutically correct substitutions. In addition, pharmacists must be able to effectively evaluate such factors as dosage form, drug-drug and food-drug interactions in order to understand how they affect the bioequivalence of drugs and be up-to-date on all pertinent regulatory issues associated with drug substitution.

The most important circumstances under which pharmacists should consider evaluating bioequivalence involve:
  • Brand to generic substitutions
  • Generic to generic substitutions
  • Conversions to different formulations for the same drug. For example, tablet to capsule, intravenous to oral and suspension to capsule and
  • Giving specific medications with food

This program presents the views and opinions of four outstanding and highly experienced clinicians in the field of bioequivalence and bio-substitution. Their discussions and professional recommendations are based upon a combination of randomized clinical trials, current guidelines, and their respective practical clinical experiences. Some of the most important factors highlighted include:

  • Differences in patient’s ability to absorb, metabolize and eliminate specific drug formulations
  • PH of the gastro-intestinal tract
  • Gastric emptying time
  • Factors affecting intestinal motility
  • GI tract perfusion
  • Age, sex and weight
  • Disease status and
  • Drug-drug and drug-food interactions
This lesson is supported by:
        

ArcMesa Educators, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.

This home study web activity has been assigned a maximum of 1 credit hours and the
ACPE UPN: 200-000-07-001-H04-P
and
ACPE UPN: 200-000-07-001-H04-T

To receive CE credit for this course, please log onto
URL: www.rxschool.com
Email: info@rxschool.com

Contributed by:
Peter J. Rubino, M.S. Pharm., M.S., Ed.
Director, Continuing Professional Education
RxSchool.com


Pharmedium


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