Exploring New Controversies in Bioequivalency Studies for Animal Drugs

September 15, 2016 10:30am

Brian J. Malkin
Senior Counsel
McGuireWoods LLP

Elizabeth A. McGraw
General Patent Counsel, Elanco Animal Health Sr Dir., Assistant General Patent Counsel
Eli Lilly and Company (Greenfield, IN)

Bioequivalency studies are a key requirement of the Generic Animal Drug and Patent Term Restoration Act (GADPTRA), the animal drug equivalent to the Hatch Waxman Act governing human drug brand and generic market access. This panel will explore new concerns relative to bioequivalency in animal drugs and therapeutics.

  • Evaluating concerns with bioequivalence studies in all major species
  • Understanding when it is necessary to exclude certain species to procure a more accurate bioequivalency study, e.g., felines
  • Exploring benefits of invitro bioequivalency studies