ABSTRACT
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 organ. Chinese doctors believe that all organs within a healthy subject should reach global dynamic balance or harmony among organs (see, also Chow et al. 2006). Thus, a flexible dose consisting of several components with different relative proportions of these components is usually prescribed. On the basis of the fact that each component may come from different locations and/or be manufactured (or processed) at different sites, the consistency such as content uniformity and weight variation from location to location (or from site to site) is a concern for quality control and assurance of the resultant TCM especially when the TCM is used in humans.
