| 摘要: |
| 投资研发一种新型兽药的成功与失败，最终取决于管理者、兽医医师和畜主是否认同药品的安全性和有效性。药品研发成本最高、费时最长的阶段是注册前的临床药效试验阶段，研发者使用动物疾病模型技术来缩短研发时间和降低研发成本。虽然使用动物疾病模型技术获得的数据是极有价值，但这些数据并不能完全说明药品真实的临床功效。本文使用模型分析方法研究了兽医保健体系中参与者的决策顺序，以便更好的理解决定药物选择的参与者、决定药物是否准入市场的政府管理者以及制药公司之间的相互影响及影响的相对水平。因此，了解药品研发和注册如何影响治疗时药品的选用非常重要，也有助于确保药品在市场中获得最大的经济效益。 |
| 关键词: 兽医药品注册 行政管理体系 咨询 |
| DOI： |
| 投稿时间：2008-07-29修订日期：2008-11-27 |
| 基金项目: |
|
| Veterinary Clinical Drug Development and Registration – understanding the dynamics of the ‘healthcare transaction’ to achieve successful economic outcomes |
| Lloyd Reeve-Johnson |
| (DipECVPT, PGCert(Business Admin),FIBiol, FRCVS) |
| Abstract: |
| 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 |
