The complexity of multiple species approvals continues throughout the life of a product as
post-approval manufacturing changes, as well as all generic versions of approved products …

In comparing product bioavailability across animal species, it is not unusual to observe
marked interspecies differences. For many compounds, these differences reflect presystemic …

There are many similarities between the human health and animal health industries. Both
industries are research driven, have global presence, are highly regulated, and have to …

ABSTRACT The Biopharmaceutics Classification System (BCS) has been developed for
human pharmaceutical compounds to predict oral drug absorption. A similar approach for …

Products for animal health commercialization follow a structured progression from initial
concept through to regulatory approval. Typically, products are developed for use in either …

7 R. CLAXTON, J. COOK, L. ENDRENYI, A. LUCAS, MN MARTINEZ, SC SUTTON,
Estimating product bioequivalence for highly variable veterinary drugs, Journal of Veterinary …

Abstract The Biopharmaceutical Classification System (BCS) has been a prognostic tool for
assessing the potential effects of formulation on the human drug oral bioavailability. When …

The present review discusses the pharmaceutical impact of the anatomy and physiology of
the canine gastrointestinal tract to provide a comprehensive guide to the theories and …

This review provides a summary of those pharmacokinetic properties of veterinary drugs
relevant to marker residues, marker tissues, and residue depletion rates. The scientific …

There is an increasing effort to understand the many sources of population variability that
can influence drug absorption, metabolism, disposition, and clearance in veterinary species …