ABSTRACT
Traditional Chinese medicine (TCM) development the Western way involves nonclinical development and preclinical/clinical development. The purpose of nonclinical development is to ensure the quality of the TCM meets product specification and regulatory standards during the development process. Quality assurance can always be achieved by identifying, reducing/eliminating, and/or controling variabilities due to various sources of raw materials, inprocess materials, and final finished products. As a result, raw materials, in-process materials, and final finished products are usually tested for consistency at various stages of the TCM development process. On the other hand, the purpose of preclinical/clinical development focuses on safety and efficacy of the TCM under development, although it is debatable whether a well-established Chinese herbal medicine should be tested in animals before it is tested in humans.
