In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world's most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency

This book introduces the methodology for collection and identification of herbal materials, extraction and isolation of compounds from herbs, in vitro bioassay, in vivo animal test, toxicology, and clinical trials of herbal research. To fully understand and make the best use of herbal medicines requires the close combination of chemistry, biochemistry, biology, pharmacology, and clinical science. Although there are many books about traditional medicines research, they mostly focus on either chemical or pharmacological study results of certain plants. This book, however, covers the systematic study and analysis of herbal medicines in general – including chemical isolation and identification, bioassay and mechanism study, pharmacological experiment, and quality control of the raw plant material and end products.

Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".

This volume presents texts written by Austrian and Chinese experts in the field of Traditional Chinese Medicine. The issue the authors worked on is the basic problem how to make a different system of medical thinking plausible for the Western world, especially for Western medicine. This issue is considered from different viewpoints - from the viewpoint of Western medicine that is familiar with Chinese medicine and contrariwise from the viewpoint of Chinese Medicine that is familiar with its Western counterpart and from a philosophical viewpoint. In this way both differences in the theoretical systems of Western and Chinese medicine and problems of adequate translation are profundly discussed.

For over two thousand years, Traditional Chinese Medicine (TCM) has made many significant contributions to China's growth and prosperity. This textbook, based on the unique characteristics of TCM, discusses its principle theories and presents a comprehensive daily practice guide for health maintenance and disease treatment. The book provides clinical practitioners with a fundamental understanding of the essence of TCM.We highly recommend this book for students interested in TCM, Chinese medicine doctors and other healthcare professionals, biomedical researchers, and interested individuals. Readers will benefit from the inspirational viewpoints discussed in the book.

Chinmedomics: The Integration of Serum Pharmacochemistry and Metabolomics to Elucidate the Scientific Value of Traditional Chinese Medicine uses new experimental techniques and research to open doors in drug discovery and development related to traditional Chinese medicine (TCM). This book features a unique approach that combines chemometric analysis with metabolomics studies to illuminate significant changes that have occurred in syndrome states while simultaneously analyzing the efficacy of chemical ingredients in herbal medicines. Chapters provide cutting-edge information on traditional medicine, analytical technology, natural products, metabolomics, bioinformatics and their applications. This book provides a valuable resource for pharmacologists, pharmaceutical scientists, medicinal plant researchers, pharmacognosists and chemists working with TCM and highlights ways to further research and advances in this area in the future. - Presents a practical guide for new practitioners of Chinmedomics with insights on the current use and future development of this method - Each chapter includes an introduction, method, references to the latest literature, possible mechanisms of action and applications - Edited by the leading experts of research related to Chinmedomics

Serum Pharmacochemistry of Traditional Chinese Medicine: Technologies, Strategies and Applications provides a valuable and indispensable guide on the latest methods, research advances, and applications in this area. Chapters offer cutting-edge information on pharmacokinetics and pharmacodynamics, analytical chemistry, traditional medicine, natural products, bioinformatics, new technologies, therapeutic applications, and more. For researchers and students in academia and industry, this book provides a hands-on description of experimental techniques, along with beneficial guidelines to help advance research in the fields of Traditional Chinese Medicine and drug development. - Provides a valuable guide for practitioners of serum pharmacochemistry of Traditional Chinese Medicine, along with insights to its current use and future applications - Edited and written by leading scientists at the forefront of this research - Presents well written chapters that include an introduction, description of the method, and identification of chemical constituents, with applications and references to the latest research and literature

This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

The English edition of Liu Lihong’s milestone work is a sublime beacon for the profession of Chinese medicine in the 21st century. Classical Chinese Medicine delivers a straightforward critique of the politically motivated “integration” of traditional Chinese wisdom with Western science during the last sixty years, and represents an ardent appeal for the recognition of Chinese medicine as a science in its own right. Professor Liu’s candid presentation has made this book a bestseller in China, treasured not only by medical students and doctors, but by vast numbers of non-professionals who long for a state of health and well-being that is founded in a deeper sense of cultural identity. Oriental medicine education has made great strides in the West since the 1970s, but clear guidelines regarding the “traditional” nature of Traditional Chinese Medicine (TCM) remain undefined. Classical Chinese Medicine not only delineates the educational and clinical problems faced by the profession in both East and West, but transmits concrete and inspiring guidance on how to effectively engage with ancient texts and designs in the postmodern age. Using the example of the Shanghanlun (Treatise on Cold Damage), one of the most important Chinese medicine classics, Liu Lihong develops a compelling roadmap for holistic medical thinking that links the human body to nature and the universe at large.