Douglas j pisano (105 risultati)

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

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

Paperback. Condizione: Very Good. 3. It's a well-cared-for item that has seen limited use. The item may show minor signs of wear. All the text is legible, with all pages included. It may have slight markings and/or highlighting.

Condizione: good. A copy that has been read, remains in good condition. All pages are intact, and the cover is intact. The spine and cover show signs of wear. Pages can include notes and highlighting and show signs of wear, and the copy can include "From the library of" labels or previous owner inscriptions. 100% GUARANTEE! Shipped with delivery confirmation, if you're not satisfied with purchase please return item! Ships via media mail.…

Hardcover. Condizione: Fair. No Jacket. Readable copy. Pages may have considerable notes/highlighting. ~ ThriftBooks: Read More, Spend Less.

Paperback. Condizione: New. 3. The item is brand new, never used or read. It's in perfect condition and may include supplements and/or access codes or come shrink-wrapped.

Condizione: New.

Condizione: Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service.

Condizione: 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.

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Condizione: As New. Unread book in perfect condition.

Condizione: New. Brand New Original US Edition. Customer service! Satisfaction Guaranteed.

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

PAP. Condizione: New. New Book. Shipped from UK. Established seller since 2000.

Condizione: Very Good. 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.

Condizione: Very Good. Former library copy. Pages intact with possible writing/highlighting. Binding strong with minor wear. Dust jackets/supplements may not be included. Includes library markings. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.

Condizione: Good. Former library copy. Pages intact with minimal writing/highlighting. The binding may be loose and creased. Dust jackets/supplements are not included. Includes library markings. Stock photo provided. Product includes identifying sticker. Better World Books: Buy Books. Do Good.

hardcover. Condizione: Very Good. Connecting readers with great books since 1972! Used books may not include companion materials, and may have some shelf wear or limited writing. We ship orders daily and Customer Service is our top priority.

hardcover. Condizione: Gut. 464 Seiten; 9781420073546.3 Gewicht in Gramm: 1.

Paperback. Condizione: New. FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more.The Third Edition of this highly successful publication:Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketingIncludes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXELFocuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirementsProvides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) VExplains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissionsCo-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that's broadly useful to both business and academia.…

Condizione: New.

Hardcover. Condizione: New.

Condizione: New.

paperback. Condizione: New.

paperback. Condizione: New. In shrink wrap. Looks like an interesting title.

Condizione: As New. Unread book in perfect condition.

Condizione: New. 2024. 3rd Edition. paperback. . . . . .

Condizione: New. In English.

Paperback. Condizione: Brand New. 3rd edition. 400 pages. 9.00x6.00x9.02 inches. In Stock.

Condizione: New. Satisfaction Guaranteed or your money back.