Book by Mark P Mathieu Mark Mathieu Mathieu Mark P
"synopsis" may belong to another edition of this title.
Seller: World of Books (was SecondSale), Montgomery, IL, U.S.A.
Hardback. Condition: Very Good. This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products. Seller Inventory # 00095161819
Seller: Your Online Bookstore, Houston, TX, U.S.A.
Hardcover. Condition: Fair. Seller Inventory # 1882615670-4-26639192
Seller: ThriftBooks-Phoenix, Phoenix, AZ, 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 Inventory # G1882615670I4N00
Seller: ThriftBooks-Reno, Reno, NV, U.S.A.
Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I3N00
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 Inventory # G1882615670I4N00
Seller: ThriftBooks-Atlanta, AUSTELL, GA, U.S.A.
Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I3N00
Seller: ThriftBooks-Dallas, Dallas, TX, U.S.A.
Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less. Seller Inventory # G1882615670I3N00
Seller: World of Books Inc, Montgomery, IL, U.S.A.
Hardback. Condition: Very Good. This publication is the only text on Biologics Development and Regulation in the Post-CBER/CDER Consolidation Era. Completely revised and updated to address the transfer of therapeutic biological products to CDER, this all-new edition provides the most comprehensive and up-to-date analysis of the FDA's emerging processes for regulating and approving biological products. Written by CDER and CBER officials and industry experts, Biologics Development: A Regulatory Overview offers an expansive examination of the FDA's regulation of biologic products, from preclinical testing to post-marketing regulatory requirements, and from user fees to electronic submissions. Better yet, this new text provides the first detailed look inside the re-invented FDA that will regulate and approve today's biological products. Seller Inventory # CIN1882615670VG
Seller: Better World Books, Mishawaka, IN, U.S.A.
Condition: Good. 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. Seller Inventory # 57084313-6
Seller: Better World Books, Mishawaka, IN, U.S.A.
Condition: 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. Seller Inventory # 17271891-6