New Drugs : An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients by Lawrence Friedhoff (2009, Trade Paperback)

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About this product

Product Identifiers

PublisherCreateSpace
ISBN-10141969961X
ISBN-139781419699610
eBay Product ID (ePID)7038600745

Product Key Features

Number of Pages258 Pages
LanguageEnglish
Publication NameNew Drugs : An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients
Publication Year2009
SubjectDrug Guides, Preventive Medicine, Industries / Pharmaceutical & Biotechnology, Pharmacology, American Government / National
TypeTextbook
AuthorLawrence Friedhoff
Subject AreaPolitical Science, Business & Economics, Medical
FormatTrade Paperback

Dimensions

Item Height0.6 in
Item Weight12.8 Oz
Item Length8 in
Item Width5.2 in

Additional Product Features

Intended AudienceTrade
LCCN2010-279536
Dewey Edition23
IllustratedYes
Dewey Decimal615.19
SynopsisDrug development, the processes by which a chemical compound becomes a "drug" and is approved for sale by the FDA and European and Asian regulators, is not for the faint-of-heart or the shortsighted. Designing and monitoring studies, obtaining and analyzing scientific data, and reconciling clinical results against the ethical constraints and regulatory guidelines of government agencies, requires a complex interaction of in-house specialists and academic and commercial consultants worldwide. Scientific, technical, and tactical considerations play out in an environment where a balance must be struck between the often-competing interests of the corporation, its investors, government regulators, and the safety and well being of intended patients. All the while, dwindling patent protections impose an ever-contracting timeframe for success. Written to be accessible to a wide audience, NEW DRUGS provides a thorough, succinct, and practical understanding of these drug-development processes. If you're involved in the pharmaceutical industry, NEW DRUGS will provide scientific and management tools to increase the likelihood of regulatory approval at each phase of your compound's development. If you're a patient or consumer, NEW DRUGS will enable you to intelligently discuss medications with your health-care provider and empower you to make informed decisions at the pharmacy. If your portfolio, rather than your health, makes you an interested observer of the fortunes of this critical sector of the US economy, NEW DRUGS will help you to decode press releases and annual reports, so that you can recognize and invest in well-run companies with promising products.
LC Classification NumberRM301.25.F75 2009

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