New Drugs An Insider's Guide to the Fda's New Drug Approval Process for Scientists, Investors and Patients

New Drugs
  • Engels
  • Paperback
  • 9781419699610
  • juni 2009
  • 258 pagina's
Alle productspecificaties

Samenvatting

Drug 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.

Productspecificaties

Inhoud

Taal
Engels
Bindwijze
Paperback
Verschijningsdatum
2009-01-01
Aantal pagina's
258 pagina's
Illustraties
Nee

Betrokkenen

Auteur
Lawrence T Friedhoff MD
Uitgever
Booksurge Publishing

EAN

EAN
9781419699610

Overige kenmerken

Extra groot lettertype
Nee
Oorspronkelijke releasedatum
2009-06-04
Subtitel
An Insider's Guide to the Fda's New Drug Approval Process for Scientists, Investors and Patients
Thema Subject Code
MKG

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