
Pre-Owned New Drugs : An Insider's Guide to the FDA's New Drug Approval Process for Scientists, Investors and Patients
Key item features
- ISBN: 9781419699610
- Condition: Pre-Owned: Good
- Trade paperback
- Language: English
- Pages: 258
- Trade paperback (US). Glued binding. 258 p.
- 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.
Specs
- Book formatPaperback
- Fiction/nonfictionNon-Fiction
- GenreHealth, Mind & Body
- Publication dateJune, 2009
- Pages258
- PublisherBooksurge Publishing
- Free shipping
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Product details
- ISBN: 9781419699610
- Condition: Pre-Owned: Good
- Trade paperback
- Language: English
- Pages: 258
- Trade paperback (US). Glued binding. 258 p.
- 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.
What is Pre-Owned: Good?
What is the Walmart Pre-Owned Program?
Walmart Pre-Owned allows you to find previously owned, well-cared-for items from Walmart’s trusted & performance-managed sellers. Shopping Pre-Owned allows you to bring home the best-quality picks at even lower prices, in addition to extending the life of an item & reducing waste. Find your favorites & shop a range of conditions in every category.
Why Walmart Pre-Owned?
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Quality you can afford
Save even more on top brands & your most-loved items.

30-day free returns
Don’t love it? Most items offer a 30-day* free return policy, for added peace of mind.
Sustainability
Shopping Pre-Owned helps in extending the life of an item & reducing waste.
Product image for illustration purposes only. The item you receive may vary from the image in minor ways, such as slight differences in appearance, color, and/or design. *Exceptions apply during holiday season, and on certain electronics, collectibles, and jewelry.
Pre-Owned: Good
What is the Walmart Pre-Owned Program?
Walmart Pre-Owned allows you to find previously owned, well-cared-for items from Walmart’s trusted & performance-managed sellers. Shopping Pre-Owned allows you to bring home the best-quality picks at even lower prices, in addition to extending the life of an item & reducing waste. Find your favorites & shop a range of conditions in every category.
Why Walmart Pre-Owned?

Trusted sellers & quality items
Each Pre-Owned item listed comes from Walmart’s trusted performance-managed sellers, to ensure you get quality items.
Quality you can afford
Save even more on top brands & your most-loved items.

30-day free returns
Don’t love it? Most items offer a 30-day* free return policy, for added peace of mind.

Sustainability
Shopping Pre-Owned helps in extending the life of an item & reducing waste.
Product image for illustration purposes only. The item you receive may vary from the image in minor ways, such as slight differences in appearance, color, and/or design. *Exceptions apply during holiday season, and on certain electronics, collectibles, and jewelry.
