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OJVRTM
Online Journal of Veterinary Research©
Volume 12 (1) :20-27,
2008
Veterinary
Clinical Drug Development and Registration: understanding
the dynamics of the ‘healthcare transaction’ to achieve successful
economic
outcomes
Goyd
Project Solutions,
Reeve-Johnson L, Veterinary Clinical Drug Development and Registration – understanding the dynamics of the ‘healthcare transaction’ to achieve successful economic outcomes. Online Journal of veterinary Research, 12 (1) :20-27, 2008. Success or failure of an investment to develop a new veterinary product is ultimately dependent upon the perception of the safety and efficacy by the regulator, veterinary clinician and animal owner. The most costly and time-expensive phase of product development is the pre-registration clinical efficacy testing. Disease modeling techniques have been used to attempt to save both development time and cost. While they are valuable predictive indicators, there are limitations to the transferability of this data to effectiveness in the clinic 1. This paper examines the decision sequence of the veterinary healthcare system using modeling approaches to better understand the interplay between the patient/client/clinician team making the decision whether or not to choose a product, and the pharmaceutical company and government regulator who determine which products are made available to the market. All participants influence the adoption / use of products, but differ in the relative level of influence. It is useful to understand how the adoption of therapeutic products can be influenced both for development and product registration purposes as well as to assure ultimate financial return in the marketplace.
Key words: “veterinary product registration,
regulatory
affairs, consultancy”