Bioavailability and Bioequivalence: The Basics and Beyond

* Enrollment for this unique and highly rated “BABE” course is limited so please REGISTER early.

COURSE DESCRIPTION

For the most part, the decision to deem two different drug formulations as “bioequivalent” depends on the outcome of properly conducted bioavailability studies in healthy human volunteers. Although the key measures of bioavailability, namely the rate and extent of absorption are easily obtained, the broader issue of bioequivalence assessment remains contentious and controversial. Perhaps reflecting this state of uncertainty, various procedures and standards for determining bioequivalence have been promulgated over the past two decades by government regulatory agencies worldwide. Fortunately, thanks to international harmonization efforts, current bioavailability/ bioequivalence guidelines issued in North America and Europe at least now have many common elements.

Following an introduction to basic pharmacokinetics, this comprehensive course, as its alliterative title implies, will focus on current as well as proposed “metrics” for assessing bioequivalence. Skillfully presented lectures and hands-on problem solving exercises will provide attendees with a thorough understanding of what is often perceived as an esoteric and difficult area of applied pharmacokinetics.  This course has been highly rated by both experienced and entry-level regulatory, clinical and laboratory personnel from generic AND research-based pharmaceutical companies.

PARTIAL COURSE CONTENTS

  • Basic pharmacokinetics principles
  • Bioavailability determinants (AUCt, AUCinf, Cmax,Tmax, etc.)
  • Design of both single and multiple dose studies
  • Mean versus individual ratio analyses
  • Confidence interval calculations
  • Food and other factors affecting bioavailability
  • Controlled release formulations
  • Cmax – Cmin fluctuations
  • Intrasubject variability
  • Drug interchangeability (“prescribability” versus “switchability”)
  • In vitro dissolution as a predictor of bioequivalence
  • Cmax/AUC and other proposed metrics for drug absorption rate
  • Instances of possible use of metabolite data
  • Therapeutic equivalence
  • US, Canadian (incl. 2010 revisions) & European regulatory requirements
  • Problem areas (e.g. highly variable drugs, nonlinearity)
  • “Hands-on”exercises

PRINCIPAL INSTRUCTOR > Peter W. Mullen, PhD, FCSFS

 

VENUE

2017 presentation dates to be determined
Ottawa, Ontario

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