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Statistical Issues in Drug Development by Stephen S Senn

Statistical Issues in Drug Development Stephen S Senn ebook
ISBN: , 9780470018774
Page: 524
Publisher: Wiley-Interscience
Format: pdf

Great post although I think you did leave out some aspects of the research cost but, as you say, those costs are a relatively small piece of the total drug development picture. I've also often found that people are extremely surprised when they hear about how IP and chemical space issues can delay programs and drain resources. Manufacturers refer to the costs of drug development when explaining high drug prices: New drugs are expensive, we're told, because developing drugs is a risky, costly, time consuming endeavor. There have been many developments since the first edition of this book and it was high time for a second. How can clinical trials be simplified in cost and complexity while maintaining ethics and statistical certainty? Analysis of the drug development enterprise invariably reveals a “pipeline” problem—a disconnection between the substantial resources invested in developing new therapies and the rate at which innovative therapeutic products reach patients. Reflecting the fact that regulatory agencies recently required companies to initiate a pediatric drug development plan earlier in the drug development sequence for compounds first developed for adults, most psychiatric drugs for children still remain the offspring of adult drug development programs, viz., except for the .. Statistical Issues in Drug Development. Http://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/highlights.pdf. The high prices for new treatments are the price of innovative new .. At the moment there is no legal framework for such a type of preventive intervention and there is relatively little ethical debate about these issues [68]. # François Luong on 06 Dec 2012 at 5:41 pm.