Piribo (PRWEB) March 6, 2006
(http://www.piribo.com) the online destination for business intelligence for the biotech and pharmaceutical industry, has now added a new book entitled “Expediting Drugs and Biologics Development: A Strategic Approach 2006”
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.
“Expediting Drugs and Biologics Development: A Strategic Approach 2006” is priced at £80 and is available in hard copy format from Piribo. For more information go to: http://www.piribo.com/publications/research_development/expediting_drugs_biologics_development.html
Piribo is a UK-based independent online store supplying business information on the pharmaceutical and biotechnology industries. The website now carries over 3,000 English language titles including, market reports, studies and books and is the UK’s largest online biopharma information store. Subscribers receive a free monthly newsletter and email alerts on new titles in their areas of interest. The company was established in 2004.