Mark Mathieu (90 results)

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.…

Hardcover. Condition: Fair.

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

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

Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.

Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.

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.…

Hardcover. 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.

paperback. Condition: Good. Satisfaction 100% guaranteed.

Condition: good. The book is in good condition with all pages and cover intact, including the dust jacket if originally issued. The spine may show light wear. Pages may contain some notes or highlighting, and there might be a "From the library of" label. Boxed set packaging, shrink wrap, or included media like CDs may be missing.…

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

Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.

Condition: Good. 6th. 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.

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.

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.

Condition: Like New. Like New. Clean, Tight and Neat. Five star seller - Buy with confidence.

Spiral-bound. Condition: Fair. May 2012. Grade 1 out 5 points. This book is VERY used with a little bit of life remaining. Book has HEAVY wear, creases and tears on cover and pages. Books with this grade may have any of the following: Personalized notes/names, stickers/labels, markings on pages, bends/crease on cover/spine, ex-library markings, minor water damage. May not include extra materials such as dust jackets, access codes, CDs, accessories, etc. All orders ship by next business day! We are a small company and very thankful for your business. …

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.

Condition: Very Good. 7th. 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.

Hardcover. Condition: Fair. Book in Fair condition.

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.

Hardcover. Condition: Good. No Jacket. Pages can have notes/highlighting. Spine may show signs of wear. ~ ThriftBooks: Read More, Spend Less.

Condition: Good. 6th 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.

softcover. Condition: Used; Like New. First Edition; First Printing. Illustrated with 13 full-page plates of works by Chris Burden, Kenneth Capps, Jill Giegerich, Mathieu Gregoire, Margaret Honda, and Mark Lere. Essay by Michael McManus. Published on the occasion of the exhibition held at Mandeville Art Gallery, University of California, San Diego, April 4 to May 3, 1987. ; Tight, clean and crisp. In excellent condition. No inscriptions. No remainder mark. Not ex-library. As New.…

hardcover. Condition: Good. Hardback--marking on pages--spine and pages excellent.

Condition: 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.…

Condition: very_good. Gently read. May have name of previous ownership, or ex-library edition. Binding tight; spine straight and smooth, with no creasing; covers clean and crisp. Minimal signs of handling or shelving. 100% GUARANTEE! Shipped with delivery confirmation, if you're not satisfied with purchase please return item! Ships USPS Media Mail.…

Hardcover. Condition: As New. Dust Jacket Condition: As New. 1st Edition. 273 pp., xi. '1' in number line. Contents divided into 17 Essays in 2 Parts: Part I DEBATES OVER AUTHORITY IN MEDICAL DECISION-MAKING Andrea L. Bonnicksen, "Introduction"; (1) William J. Winslade, "End-of-Life Medicine, Law, and Ethics: A Twilight Zone"; (2) John J. Paris and Frank Reardon, "Physician Refusal of Requests for Futile or Ineffective Interventions"; (3) Tom Tomlinson, "Refusing Demands for Attempted Resuscitation: Ethics and Hospital Policy"; (4) Robert Baker and Martin Strosberg, "The Bioethical Revolution of 1988: The Future of the Futility Controversy"; (5) Marion Danis and Larry Churchill, "Evolving Trends for Advance Directives"; (6) Timothy E. Quill, "A Case of Individualized Decision Making"; (7) Albert R. Jonsen, "Reflection on Washington State's Initiative 119"; (8) Robert W. Wood and Ralph Mero, "Washington State's ' Death with Dignity ' Initiative"; (9) Richard M. Zaner and Mark D. Fox, "Selective Termination and Moral Risk: Choices and Responsibility"; (10) Eugene Pergament. "In Utero Treatment: Fetal Surgery"; Part II NEW CHALLENGES IN MEDICAL EXPERIMENTATION Robert H. Blank, "Introduction'; (11) Charles R. McCarthy, "Overview: Challenges for the 1990s"; (12) Carol Levine, "Women as Research Subjects: New Priorities, New Questions"; (13) Joan Porter, Marta Glass, and Wayne Koff, "International AIDS Vaccine Trials"; (14) John C. Fletcher, "Human Fetal and Embryo Research: Lysenkoism in Reverse--How and Why?"; (15) Mary B. Mahowald, "Brain Development, Personality, and Neurografts"; (16) Deborah Mathieu, "Ending the Experiment: Dilemmas of the Experimental/Therapeutic Distinction"; (17) Arnold E. Relman, "Economic Incentives in Clinical Investigation"; "About the Contributors", pp. 269-273. Blue cloth with brilliant gilt lettering on spne; Medium gray endpapers. Glossy dustwrapper not price-clipped (NO price) with medium gray vertical side borders for vertical light gray wide strip down middle front cover, with larger and smaller yellow Title and Editor Names boxes (for dark blue lettering) across top and bottom front cover, respectively. Very faint stain at foot of fore-edge (trapezoidal, 3/8" x 5/8", light Tan [vs. white remainder]; NO warping, NO odor, NO bleeding onto truly trivial); Cosmetic: very small bump-wrinkle to dw only at top spine and small dimple at gutter just below midpoint on left front cover, else unqualifiedly As New: Review Copy with Review slip laid in (Orig. Price in 1993, $45.00): Tight binding (NO cracks); Sharp corners (NO bumps or curls);NO rubbing wear; NO previous owner names. Clean text. UNREAD. Essentially: Flawless. …

Soft cover. Condition: Near Fine. 1882615557. Softcover, from closed pharmaceutical company library. Lending record shows this book has never been borrowed. 492 pages, index. Addresses cutting-edge developments, redefining how new drugs are developed and regulated Contents clean, tight and bright. Book. …

Condition: fine. Spécimen enseignant. Photo non contractuelle. Envoi rapide et soigné.