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OJVRTM
Online
Journal of Veterinary Research©
Volume 12 (1) :15-26,
2008. Redacted 2018.
Veterinary Clinical Drug Development and
Registration: dynamics of healthcare transaction
to achieve successful economic outcomes.
Goyd
Project Solutions, Goyd Park, 79 Layfield
Road, Anstead Q4070 ,
Australia Contact: projectmanagement@goydpark.com
web address: www.goydpark.com§
Reeve-Johnson L, Veterinary
Clinical Drug Development and Registration – dynamics of the ‘healthcare
transaction’ to achieve successful economic outcomes. Onl J
Vet Res., 12 (1) :15-26, 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. 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”