學名藥分析方法開發專案-應用FMEA及DOE 方法

A study of FMEA and DOE method: case of generic drug analytic method development project

劉英良(Liu Ying-Liang)

指導教授 ： 任恆毅

元智大學/工程學院/工業工程與管理學系/碩士(2009年)

摘要

當原開發廠某一專利藥過期時，學名藥廠藉由首先獲准上市的學名藥往往可以提高自己的市場地位。首先得到FDA第一認證的學名藥廠公司，他們有六個月獨賣期。在這六個月期間，他們可以使用有利定價策略和建立物流管道獲取大部分份市場佔有率。所以，新產品越快能上市對於產品的競爭有是關鍵性影響。
本研究整合專案風險管理(PRM)和實驗設計 (DOE)兩種方法，加速申請學名藥計畫中所要求開發和確效一個分析方法的專案。以期增加公司的效率和早期獲利。 此外，研究案例顯示整合兩方法所得效益。

關鍵字

風險管理, 學名藥, 分析方法開發, FMEA, DOE

並列摘要

Generic drug companies tend to improve their market position by being first in the market when a patent on an original product elapses. When a company gets the first approval of FDA, they have six months of marketing exclusivity. During the six months, they can use aggressing pricing and build logistic power to get the lion’s share. Therefore, the time-to-market of new products is crucial to their comparative advantages.
This research tries to integrate project risk management (PRM) approach and design of experiment (DOE) to speed up the critical project, which is required to develop and validate an analytical method in Abbreviated New Drug Applications (ANDA) program, to increase the company’s efficiency and to get the revenue in the early stage. Furthermore, a case study was implemented to demonstrate the efficiency of this integration.

並列關鍵字

Risk Management, Generic Drug, Analytic Method Development, FMEA, DOE

參考文獻

[5] D. Pons, "Project management for new product development," Project Management Journal, vol. June, pp. 82-97, 2008.

[6] ICH, "Quality Risk Management." vol. Quality Guide: International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, 2006.

[7] C. Woolston, "Generic Drug Savings," CONSUMER HEALTH INTERACTIVE, 2003.

[8] A. K. Basak, A. S. Raw, A. H. Al Hakim, S. Furness, N. I. Samaan, D. S. Gill, H. B. Patel, R. F. Powers, and L. Yu, "Pharmaceutical impurities: Regulatory perspective for Abbreviated New Drug Applications," Advanced Drug Delivery Reviews, vol. 59, pp. 64-72, 2007.

[9] G. F. Meyer, "History and regulatory issues of generic drugs," Transplantation Proceedings, vol. 31, pp. 10S-12S, 1999.