Condition: Good. A sound copy with only light wear. Overall a solid copy at a great price!
Seller: TextbookRush, Grandview Heights, OH, U.S.A.
Condition: Good. Expedited orders RECEIVED in 1-5 business days within the United States. Orders ship SAME or NEXT business day. We proudly ship to APO/FPO addresses. 100% Satisfaction Guaranteed!
Seller: TextbookRush, Grandview Heights, OH, U.S.A.
Condition: Very Good. Expedited orders RECEIVED in 1-5 business days within the United States. Orders ship SAME or NEXT business day. We proudly ship to APO/FPO addresses. 100% Satisfaction Guaranteed!
Language: English
Published by CRC Press (edition 3), 2024
ISBN 10: 1032920548 ISBN 13: 9781032920542
Seller: BooksRun, Philadelphia, PA, U.S.A.
Paperback. Condition: 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.
Language: English
Published by CRC Press (edition 3), 2024
ISBN 10: 1032920548 ISBN 13: 9781032920542
Seller: BooksRun, Philadelphia, PA, U.S.A.
Paperback. Condition: 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.
Condition: Good. Item in good condition. Textbooks may not include supplemental items i.e. CDs, access codes etc.
hardcover. Condition: Good. Connecting readers with great books since 1972! Used textbooks may not include companion materials such as access codes, etc. May have some wear or writing/highlighting. We ship orders daily and Customer Service is our top priority!
Condition: acceptable. This book is in acceptable condition and may have highlighting and or writing throughout. The actual cover image may not match the stock photo, dust jacket may be damaged or missing. Book may show internal and or external wear on spine or cover and may be slightly skewed or have creased pages. This is a used book so codes may be invalid or accompanying media may be missing. May be an Ex library book with stickers and stamps.
Condition: New.
Condition: Brand New. New. US edition. Expediting shipping for all USA and Europe orders excluding PO Box. Excellent Customer Service.
Condition: 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.
Condition: New.
Condition: New. Brand New Original US Edition. Customer service! Satisfaction Guaranteed.
Condition: New.
Condition: As New. Unread book in perfect condition.
Seller: ThriftBooks-Atlanta, AUSTELL, GA, U.S.A.
Hardcover. Condition: Very Good. No Jacket. May have limited writing in cover pages. Pages are unmarked. ~ ThriftBooks: Read More, Spend Less.
Seller: HPB-Diamond, Dallas, TX, U.S.A.
hardcover. Condition: 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!
PAP. Condition: New. New Book. Shipped from UK. Established seller since 2000.
Condition: New.
Seller: Greenworld Books, Arlington, TX, U.S.A.
Condition: good. Fast Free Shipping â" Good condition. It may show normal signs of use, such as light writing, highlighting, or library markings, but all pages are intact and the book is fully readable. A solid, complete copy that's ready to enjoy.
Condition: NEW.
Language: English
Published by Taylor and Francis Ltd, GB, 2024
ISBN 10: 1032920548 ISBN 13: 9781032920542
Seller: Rarewaves.com USA, London, LONDO, United Kingdom
Paperback. Condition: 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.
US$ 64.45
Quantity: 2 available
Add to basketCondition: New.
US$ 69.62
Quantity: 1 available
Add to basketCondition: New. In.
Seller: medimops, Berlin, Germany
Condition: good. Befriedigend/Good: Durchschnittlich erhaltenes Buch bzw. Schutzumschlag mit Gebrauchsspuren, aber vollständigen Seiten. / Describes the average WORN book or dust jacket that has all the pages present.
US$ 69.38
Quantity: 1 available
Add to basketpaperback. Condition: New.
US$ 73.67
Quantity: 2 available
Add to basketCondition: As New. Unread book in perfect condition.
US$ 85.23
Quantity: 1 available
Add to basketPaperback. Condition: Brand New. 3rd edition. 400 pages. 9.00x6.00x9.02 inches. In Stock.
Seller: Studibuch, Stuttgart, Germany
hardcover. Condition: Gut. 464 Seiten; 9781420073546.3 Gewicht in Gramm: 1.
Hardcover. Condition: Very Good. No Jacket. 2nd Edition. 2008.Hardcover.Very good condition.448 pages.Ships from Japan.Usually ships in 1-2 working days.