臺灣博碩士論文加值系統

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。

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.

1 Introduction 1
1.1 Research Background 1
1.2 Research Question 2
1.3 Research Objective 3
2 Literatures Review 5
2.1 Generic Drug 5
2.2 Project Risk Management 10
2.2.1 Risk identification 12
2.2.2 Qualitative Risk Analysis 13
2.2.3 Quantitative Risk Analysis 15
2.2.4 Risk response planning 16
2.2.5 Risk Monitoring and Control 17
2.3 Failure Mode and Effects Analysis 17
2.4 Plackett-Burman Design 23
3 Research Process 24
3.1 High Performance Liquid Chromatography (HPLC) 24
3.2 Risk Analysis 25
3.3 Experiment Design 26
4 Case Study 28
4.1 Chemical and Reagents 28
4.2 Instrumentation 29
4.3 Preparation of solutions 30
4.3.1 Drug stock solution and internal standard 30
4.3.2 Sample preparation 30
4.3.3 Risk Assessment 30
4.3.4 Measurement system analysis (Gage R&;R) 36
4.3.5 Robustness Study 36
4.3.6 Method Validation 54
5 Conclusion and Further Research 60
Reference 62

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