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  • New drug development : a regulatory overview / by Mark Mathieu ; with contributions from Christopher-Paul Milne.

    • Text
    • Waltham, MA : PAREXEL International Corp., [2008], ©2008.
    • 2008-2008
    • 1 Item
    FormatCall NumberItem Location
    Text RA401.A3 N48 2008 QOff-site

  • Development of FDA-regulated medical products : prescription drugs, biologics, and medical devices / Elaine Whitmore.

    • Text
    • Milwaukee, Wis. : ASQ Quality Press, [2004], ©2004.
    • 2004-2004
    • 2 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text RA401.5 .W48 2004Off-site
    Request for On-site UseRequest Scan
    Not available - Please for assistance.

  • A Textbook of pharmaceutical medicine : current practice / edited by R.D. Mann, M.D. Rawlins, R. Auty.

    • Text
    • Carnforth, Lancs, UK ; Pearl River, N.Y., USA : Parthenon Pub. Group, 1993.
    • 1993
    • 1 Item
    FormatCall NumberItem Location
    Text RM301.25 .T49 1993Off-site

  • Ethical issues in drug testing, approval, and pricing : the clot-dissolving drugs / Baruch A. Brody.

    • Text
    • New York : Oxford University Press, 1995.
    • 1995
    • 1 Item
    FormatCall NumberItem Location
    Text RM340 .B76 1995Off-site

  • Cardiovascular drug development : protocol design and methodology / edited by Jeffrey S. Borer, John C. Somberg.

    • Text
    • New York : M. Dekker, c1999.
    • 1999
    • 1 Item
    FormatCall NumberItem Location
    Text RM345 .C37525 1999Off-site

  • Manufacturing of gene therapeutics : methods, processing, regulation, and validation / edited by G. Subramanian.

    • Text
    • New York : Kluwer Academic/Plenum Publishers, c2002.
    • 2002
    • 1 Item
    FormatCall NumberItem Location
    Text RB155.8 .M36 2002Off-site

  • This man's pill : reflections on the 50th birthday of the pill / Carl Djerassi.

    • Text
    • Oxford ; New York : Oxford University Press, 2001.
    • 2001
    • 1 Item
    FormatCall NumberItem Location
    Text RG137.5 .D57 2001Off-site

  • Safety pharmacology in pharmaceutical development and approval / Shayne C. Gad.

    • Text
    • Boca Raton, Fla. : CRC Press, c2004.
    • 2004
    • 1 Item
    FormatCall NumberItem Location
    Text RA1238 .G333 2004Off-site

  • Drugs : from discovery to approval / Rick Ng.

    • Text
    • Hoboken, N.J. : Wiley-Liss, c2004.
    • 2004
    • 1 Item
    FormatCall NumberItem Location
    Text RM301.25 .N5 2004Off-site

  • Anticancer drug development guide : preclinical screening, clinical trials, and approval / edited by Beverly A. Teicher, Paul A. Andrews.

    • Text
    • Totowa, N.J. : Humana Press, c2004.
    • 2004
    • 1 Item

    Available Online

    http://www.loc.gov/catdir/toc/ecip0411/2003024925.html
    FormatCall NumberItem Location
    Text RC271.C5 A6722 2004Off-site

  • Making better drugs for children with cancer : Committee on Shortening the Time Line for New Cancer Treatments, National Cancer Policy Board / Peter C. Adamson [and others], editors ; Institute of Medicine and National Research Council of the National Academies.

    • Text
    • Washington, D.C. : National Academies Press, [2005], ©2005.
    • 2005-2005
    • 1 Item
    FormatCall NumberItem Location
    Text RA401.5 .N38 2005Off-site

  • The textbook of pharmaceutical medicine / edited by John P. Griffin and John O'Grady.

    • Text
    • Oxford ; Malden, Mass. : Blackwell, [2006], ©2006.
    • 2006-2006
    • 2 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text RM301.25 .T49 2006Off-site

  • Developing a national registry of pharmacologic and biologic clinical trials : workshop report / Committee on Clinical Trial Registries, Board on Health Sciences Policy.

    • Text
    • Washington, D.C. : National Academies Press, [2006], ©2006.
    • 2006-2006
    • 3 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text R853.C55 D48 2006Off-site
    FormatCall NumberItem Location
    Text R853 .D484 2006gOff-site

  • Clinical trial registries : a practical guide for sponsors and researchers of medicinal products / edited by MaryAnn Foote.

    • Text
    • Basel ; Boston : Birkhäuser Verlag, [2006], ©2006.
    • 2006-2006
    • 1 Item
    FormatCall NumberItem Location
    Text R853.C55 C576 2006Off-site

  • The future of drug safety : promoting and protecting the health of the public / Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice ; Alina Baciu, Kathleen Stratton, Sheila P. Burke, editors.

    • Text
    • Washington, DC : National Academies Press, [2007], ©2007.
    • 2007-2007
    • 2 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text RA401.A3 I568 2007Off-site

  • The future of drug safety : promoting and protecting the health of the public / Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice, Alina Baciu, Kathleen Stratton, Sheila P. Burke, editors.

    • Text
    • Washington, D.C. : National Academies Press, [2006], ©2006.
    • 2006-2006
    • 1 Item
    FormatCall NumberItem Location
    Text KF3885 .F88 2006Off-site

  • Challenges for the FDA : the future of drug safety : workshop summary / Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies ; Leslie Pray and Sally Robinson, rapporteurs.

    • Text
    • Washington, DC : National Academies Press, [2007], ©2007.
    • 2007-2007
    • 1 Item
    FormatCall NumberItem Location
    Text RM301.27 .S96 2007gOff-site

  • Statistical thinking for non-statisticians in drug regulation / Richard Kay.

    • Text
    • Chichester, England ; Hoboken, NJ : John Wiley & Sons, [2007], ©2007.
    • 2007-2007
    • 2 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text R853.C55 K39 2007Off-site

  • Development and approval of combination products : a regulatory perspective / edited by Evan B. Siegel.

    • Text
    • Hoboken, N.J. : Wiley, [2008], ©2008.
    • 2008-2008
    • 2 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text RA401.5 .D48 2008Off-site

  • Before Prozac : the troubled history of mood disorders in psychiatry / Edward Shorter.

    • Text
    • Oxford ; New York : Oxford University Press, 2009.
    • 2009
    • 1 Item
    FormatCall NumberItem Location
    Text RC537 .S52 2009Off-site

  • Drugs : from discovery to approval / Rick Ng.

    • Text
    • Hoboken, N.J. : Wiley-Blackwell, [2009], ©2009.
    • 2009-2009
    • 1 Item
    FormatCall NumberItem Location
    Text RM301.25 .N5 2009Off-site

  • A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis.

    • Text
    • Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
    • 2010
    • 1 Item

    Available Online

    http://www.loc.gov/catdir/enhancements/fy0917/2009020427-t.html
    FormatCall NumberItem Location
    Text R853.C55 L58 2010Off-site

  • Considerations for ensuring safety and efficacy of vaccines and therapeutic proteins manufactured by using platform approaches : summary of a workshop / Jeffrey Fox, Marilee Shelton-Davenport, and India Hook-Barnard, rapporteurs ; Board on Life Sciences, Division on Earth and Life Studies, National Research Council of the National Academies.

    • Text
    • Washington, D.C. : National Academies Press, c2010
    • 2010
    • 1 Item

    Available Online

    http://books.nap.edu/openbook.php?record_id=12899
    FormatCall NumberItem Location
    Text UG447.8 .C66 2010gOff-site

  • Clinical trial methodology / Karl E. Peace, Ding-Geng (Din) Chen.

    • Text
    • Boca Raton : Chapman and Hall/CRC Press, c2011.
    • 2011
    • 1 Item
    FormatCall NumberItem Location
    Text R853.C55 P43 2011Off-site

  • Early drug development : strategies and routes to first-in-human trials / edited by Mitchell N. Cayen.

    • Text
    • Hoboken, N.J. : Wiley, c2010.
    • 2010
    • 1 Item
    FormatCall NumberItem Location
    Text RM301.25 .E27 2010Off-site

  • Medical proofs, social experiments : clinical trials in shifting contexts / [edited] by Catherine Will and Tiago Moreira.

    • Text
    • Farnham, Surrey, UK : Ashgate, 2010.
    • 2010
    • 1 Item
    FormatCall NumberItem Location
    Text R853.C55 M42 2010Off-site

  • Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development : workshop summary / Steve Olson and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Institute of Medicine of the National Academies.

    • Text
    • Washington, D.C. : National Academies Press, c2012.
    • 2012
    • 2 Items
    FormatCall NumberItem Location
    Text Off-site
    Not available - Please for assistance.
    FormatCall NumberItem Location
    Text RM301.25 .S768 2011gOff-site

  • Safety pharmacology in pharmaceutical development : approval and post marketing surveillance / Shayne C. Gad.

    • Text
    • Boca Raton, FL : CRC Press, [2012], ©2012.
    • 2012-2012
    • 1 Item
    FormatCall NumberItem Location
    Text RA1238 .G333 2012Off-site

  • Ethical and scientific issues in studying the safety of approved drugs / Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Board on Population Health and Public Health Practice, Institute of Medicine of the National Academies.

    • Text
    • Washington, D.C. : National Academies Press, [2012], ©2012.
    • 2012-2012
    • 1 Item
    FormatCall NumberItem Location
    Text RM301.27 .E84 2012gOff-site

  • Generic and innovator drugs : a guide to FDA approval requirements / Donald O. Beers.

    • Text
    • Englewood Cliffs, NJ : Aspen Law & Business, c1995.
    • 1995
    • 1 Item
    FormatCall NumberItem Location
    Text KF3894.G45 B44x 1995Off-site

  • To America's health : a proposal to reform the Food and Drug Administration / Henry I. Miller.

    • Text
    • Stanford, Calif. : Hoover Institution Press, 2000.
    • 2000
    • 1 Item
    FormatCall NumberItem Location
    Text RA401.A3 M55 2000Off-site

  • Mifegyne : pro und contra Abtreibungspille / Claudia Semrau, Ute Watzlawick ; mit Beiträgen von Johannes Huber, Peter Husslein, Peter Kampits.

    • Text
    • Wien : Maudrich, 1999.
    • 1999
    • 1 Item
    FormatCall NumberItem Location
    Text RG137.6.M53 S46 1999Off-site

  • The acquisition of drug and biologics for chemical and biological warfare defense : Department of Defense interactions with the Food and Drug Administration / Richard A. Rettig, Jennifer Brower, with Orlie Yaniv.

    • Text
    • Santa Monica, Calif. : Rand, 2003.
    • 2003
    • 1 Item
    FormatCall NumberItem Location
    Text AS36 .R4 MR-1659Off-site

  • Guidebook for drug regulatory submissions / Sandy Weinberg.

    • Text
    • Hoboken, N.J. : John Wiley, c2009.
    • 2009
    • 1 Item
    FormatCall NumberItem Location
    Text KF3885 .W45 2009Off-site

  • Pharmaceutical safety withdrawals : a comparative study of the United States and Canada / Dominika A. Jegen.

    • Text
    • Youngstown, N.Y. : Teneo Press, c2009.
    • 2009
    • 1 Item
    FormatCall NumberItem Location
    Text RA401.A1 J44 2009Off-site

  • Reputation and power : organizational image and pharmaceutical regulation at the FDA / Daniel Carpenter.

    • Text
    • Princeton : Princeton University Press, ©2010.
    • 2010
    • 1 Item
    FormatCall NumberItem Location
    Text RA401.A3 C37 2010Off-site
    Not available - Please for assistance.

  • Reinventing the regulation of cancer drugs : accelerating approval and expanding access / President Bill Clinton, Vice President Al Gore.

    • Text
    • [Washington, D.C.?] : National Performance Review, [1996]
    • 1996
    • 1 Item
    FormatCall NumberItem Location
    Text PRVP 42.2:D 84/3Off-site

  • Current issues in human subject protection : an FDA perspective : September 13, 1996, Natcher Auditorium.

    • Text
    • [Rockville, MD] : Food and Drug Administration, [1996?]
    • 1996
    • 1 Item
    FormatCall NumberItem Location
    Text HE 20.4002:H 88Off-site

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