In the exciting and rapidly expanding field of drug development, there is an emphasis on the clear delineation of psychiatric symptoms, syndromes and disorders, and disorders, and improved strategies for making diagnoses. Here the authors concentrate on the anxiolytics, a group of drugs which must be evaluated in carefully defined groups of patients using sensitive outcome measures. Efficacy is not always easy to establish and large clinical trials are needed to verify effectiveness of the drug, the degree of efficacy and the risks of unwanted effects. Conducting these trials is not an easy matter and this timely, critical and comprehensive guide aims to provide awareness of the major issues surrounding development of anxiolytics and, in particular, details of the techniques needed to assess new and hopefully improved therapies. This book, written by authors well known for their extensive experience in the field of drug development, will be of interest to the academic community frequently involved in clinical trials of potential anxiolytic compounds, as well as to the pharmaceutical industry in the formulation of drug development programmes for new anxiolytics.
Dr. Cutler, CEO of WCT, has a proven track record. He was Founder and Chairman of Worldwide Clinical Trials, Inc. (“Old WCT”), a global CRO providing a full range of product development services on a global basis to the pharmaceutical and biotechnology industries from 1986-1999, which was successfully merged into another CRO. In addition, he was founder and served as Director of California Clinical Trials, one of the largest Phase I-III clinical pharmacology and investigational sites in the U.S. From 2000 to 2006, he was the founder of and served as President and CEO of Alamo Pharmaceuticals, LLC. Dr. Cutler is a board-certified psychiatrist, and is also board-qualified in both neurology and clinical pharmacology. He was active at the National Institutes of Health for over nine years in a variety of positions such as Deputy Clinical Director of the National Institute on Aging, and Chief, Section on Brain Aging and Dementia. Currently, he is President of the American Foundation for Clinical Pharmacology, and serves on a special emphasis panel review committee for the National Institute on Aging for the National Institutes of Health. Dr. Cutler has been invited to give several hundred international and national presentations in the areas of aging, clinical pharmacology, and drug development, and has authored over 226 publications including nine books on the topics of clinical pharmacology, aging, Alzheimer’s disease, schizophrenia, anxiety disorders, and diabetes.