Expediting drug and biologics development: A strategic approach

Using a unique reverse-engineering approach, dozens of leading experts with extensive experience in all disciplines of drug and biologic development show how careful planning and a sharp focus on the end-goals can be used to expedite even the most complex product development programs today! From the first preclinical testing to clinical trials to the NDA/BLA review, Expediting Drug and Biologics Development shows you how to use reverse-engineering techniques to drive and improve each aspect of a development program's design and implementation. The new third edition of Expediting Drug and Biologics Development is not a summary of U.S. or international regulatory requirements. Rather, it is a real-world doer's guide to drug and biologics development. It provides dozens of templates, forms, and tools to assists those in the trenches of new drug and biologic development today. With this book, you will learn how to: * Apply the very latest and most advanced project management techniques directly to challenges presented by the drug development process. * Critically evaluate the needs of the package insert and marketing application up front, before getting deeply into clinical trials. * Leverage standardization to drive and expedite the entire development process, from the development of clinical trial protocols to the development of clinical data presentations. * Critically assess the needs of the final report before developing the clinical protocol. * Use draft case report forms (CRF) to dictate the content of the procedures section of the clinical protocol. * Constructively consider the methods for data analysis in developing the clinical protocol. In addition, Expediting Drug and Biologics Development 2006 will provide you with direct access to the expertise and recommendations of dozens of the most experienced and forward-thinking experts in the pharmaceutical and biotechnology industries today.