Quantitative Methods for Traditional Chinese Medicine Development

Chapter 9

Statistical Process for Quality Control/Assurance

9.1 Introduction

As indicated in Chapter 1, as more and more innovator drug products are going off patent protection, the search for new medicines for treating critical and/or life-threatening diseases has become the center of attention of many investigators from either research organizations or pharmaceutical companies. As a result, the Westernization of TCM has attracted much attention in pharmaceutical/clinical research and development. A TCM typically consists of multiple components or active ingredients (e.g., extracts from herbs). In practice, the pharmacological activities of these components are usually unknown. However, it is believed that each component is targeted for a specific ...