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The Last Normal Child: Essays on the Intersection of Kids, Culture, and ... - Page 146
by Lawrence H. Diller - 2006 - 150 pages
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GMP Compliance, Productivity, and Quality: Achieving Synergy in Healthcare ...

Vinay Bhatt - Medical - 1998 - 524 pages
...Controls; In Vitro Release Testing; and In Vivo Bioequivalence Documentation. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, September 1997. 4. Lucisano, LJ 1996. A Dialogue on SUPAC. Presented at the 21st International Good...
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A Laboratory Quality Handbook of Best Practices

Donald C. Singer - Medical - 2001 - 404 pages
...the content of the draft document, contact C. Russ Rutledge, (301) 594-2455. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) September 1998 CP# JMGU1DANOJ212DFT. WPD TABLE OF CONTENTS I. INTRODUCTION 1 II. BACKGROUND...
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Modern Pharmaceutics, Fourth Edition

Gilbert S. Banker, Juergen Siepmann, Christopher Rhodes - Medical - 2002 - 864 pages
"Completely revised and expanded throughout. Presents a comprehensive integrated, sequenced approach to drug dosage formulation, design, and evaluation. Indentifies the ...
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Phytochemical Functional Foods

Ian Johnson, Gary Williamson - Technology & Engineering - 2003 - 384 pages
...clinical investigators, 1998 update, http://www.fda.gov/ oc/ohrt/irbs/faqs .html US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologies Evaluation and Research. Guidelines for industry: Good clinical practice: consolidated...
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Phytochemical Functional Foods

Ian Johnson, Gary Williamson - Technology & Engineering - 2003 - 384 pages
...clinical investigators, 1998 update, http://www.fda.gov/ oc/ohrt/irbs/faqs .html US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologies Evaluation and Research. Guidelines for industry: Good clinical practice: consolidated...
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Pharmacovigilance

Ronald D. Mann, Elizabeth B. Andrews - Medical - 2003 - 582 pages
...CDER (1999) Report to the Nation: Improving Public Health Through Human Drugs. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. Chung CS, Myrianthopoulos NC (1975) Factors affecting risks of congenital malformations. I. Analysis...
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Distribution and Administration of Potassium Iodide in the Event of a ...

Committee to Assess the Distribution and Administration of Potassium Iodide in the Event of a Nuclear Incident, Board on Radiation Effects Research, Division on Earth and Life Studies, National Research Council - Political Science - 2003 - 262 pages
...Iodide as a Thyroid Blocking Agent in Radiation Emergencies. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. 200 la. FDA (Food and Drug Administration). FDA Talk Paper. FDA's Guidance on Protection of Children...
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The AIDS Pandemic: Impact on Science and Society

Kenneth H. Mayer, H.F. Pizer - Science - 2004 - 520 pages
...considerations for accelerated and traditional approval. US Department of 85 James D Neaton Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER), October, www.fda.gov/cder/guidance/ Halloran ME, Longini IM, Jr., Struchiner CJ (1999) Design...
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Pharmacokinetics in Drug Development: Regulatory and Development Paradigms

Peter L. Bonate, Danny R. Howard - Medical - 2005 - 488 pages
...ExposureResponse Relationships: Study Design, Data Analysis, and Regulatory Applications. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, 2002 Collins JM, Zaharko DS, Dedrick RL, and Chabner BA. Potential Roles for Preclinical Pharmacology...
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