New drug approval process (27 Ergebnisse)

Paperback. Zustand: Very Good. 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.…

Paperback. Zustand: Good. 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. …

Paperback. Zustand: Very Good. No Jacket. Former library book; May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less.

Paperback. Zustand: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less.

paperback. Zustand: Like New. Most items will be dispatched the same or the next working day. An apparently unread copy in perfect condition. Dust cover is intact with no nicks or tears. Spine has no signs of creasing. Pages are clean and not marred by notes or folds of any kind.

Zustand: Good. 1st Edition. Pages intact with minimal writing/highlighting. The binding may be loose and creased. Dust jackets/supplements are not included. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.

Zustand: Very Good. 1st Edition. Pages intact with possible writing/highlighting. Binding strong with minor wear. Dust jackets/supplements may not be included. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.

Paperback. Zustand: Fine.

Paperback. Zustand: Very Good. The book has been read, but is in excellent condition. Pages are intact and not marred by notes or highlighting. The spine remains undamaged.

Zustand: Very Good. Zustand des Schutzumschlags: 11749778. 1760953771. 10/20/2025 9:49:31 AM.

Zustand: Good. 2nd Rev/Ex. Pages intact with minimal writing/highlighting. The binding may be loose and creased. Dust jackets/supplements are not included. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.

Paperback. Zustand: Brand New. 243 pages. 8.25x5.50x0.75 inches. In Stock.

Hardcover. Zustand: Very Good. Books sent promptly by first class post.

Zustand: New. pp. 664.

23 cm. original hardcover. xxii,470 pp. bibliography. references. index. "Drugs and the Pharmaceutical Sciences, a Series of Monographs". -(library stamp, a few small dents in covers, otherwise very good). 805g.

23 cm. original hardcover. xxii,470 pp. bibliography. references. index. "Drugs and the Pharmaceutical Sciences, a Series of Monographs". -(libr labels, library stamp, otherwise very good). 777g.

Zustand: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.…

Zustand: Good. Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions.…

Zustand: New. Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide.…

Zustand: New. This is a Brand-new US Edition. This Item may be shipped from US or any other country as we have multiple locations worldwide.

Zustand: New. KlappentextThe BiblioGov Project is an effort to expand awareness of the public documents and records of the U.S. Government via print publications. In broadening the public understanding of government and its work, an enlightened democ.

Zustand: Sehr gut. Zustand: Sehr gut | Seiten: 664 | Sprache: Englisch | Produktart: Bücher | Keine Beschreibung verfügbar.

Zustand: New. In English.

Zustand: New. Richard A. Guarino, Richard GuarinoThe thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and markete.

Hardcover. Zustand: Brand New. 5th edition. 529 pages. 9.50x6.25x1.50 inches. In Stock.

Buch. Zustand: Neu. Neuware - The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.Updated chapters include: - advances in international regulatory requirements, including ICH guidelines and harmonization - a step-by-step format for content, assembly, and strategic approach in filing US and global INDs, NDAs, BLAs, ANDAs, and SNDAs - the latest regulatory requirements for expediting new drug approvals - strategies for effective communication and integration of pharmaceutical personnel in all aspects of new drug development.…

XX, 424 S. Gr.-8°. Orig.-Pbd. Vorsatz gestempelt. * ISBN 0-8247-7382-9 * (Ein Titel aus unserem Online-Katalog "Naturwissenschaften - Pharmazie"). * Reihe: (Drugs and the Pharmaceutical Sciences, 30).