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Overview
This thoroughly updated and expanded second edition of Beverly Teicher's widely used classic survey provides a step-by-step guide to anticancer drug development from initial design through FDA approval. The authors have included new material on the use of high throughput screening in industry, on specialized in vitro/in vivo procedures employed by the National Cancer Institute (NCI) in preclinical drug evaluations, and on nonclinical testing to support both human clinical trials, as well as trials of biologic oncology products. The chapters on phase I, II, and III clinical trials and on novel phase II clinical trial designs for targeted therapies have been significantly updated, along with those on cancer drug development in Europe, working with the NCI, and the FDA's role in cancer drug development and setting requirements for approval.
Synopsis
Twenty-three papers collectively describe the process by which molecules are identified, tested, and approved for cancer treatment in the United States, focusing on both scientific and regulatory contexts. In vitro and in vivo methods for screening and testing are described in the first set of papers presented by Teicher (Director of Oncology Portfolio, Genzyme Corporation) and Andrews (director of preclinical sciences, Aton Pharma Inc.). Nonclinical testing to support human trials is discussed. Issues of clinical testing, including working with the National Cancer Institute and the Food and Drug Administration, are also explored. The CD-ROM contains an electronic version of the book. Annotation ©2004 Book News, Inc., Portland, OR