| Document Type
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BL
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| Record Number
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665227
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| Doc. No
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dltt
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| Title & Author
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Active pharmaceutical ingredients : : development, manufacturing, and regulation /\ edited by Stanley H. Nusim
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| Edition Statement
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2nd ed
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| Publication Statement
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New York :: Informa Healthcare,, c2010
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| Series Statement
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Drugs and the pharmaceutical sciences ;; 205
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| Page. NO
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xv, 433 p. :: ill. ;; 24 cm
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| ISBN
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9781439803363 (hb : alk. paper)
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: 1439803366 (hb : alk. paper)
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: 1438003366 (hb : alk. paper)
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: 9781438003368 (hb : alk. paper)
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| Bibliographies/Indexes
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Includes bibliographical references and index
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| Contents
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Bulk drugs : the process development task / Carlos B. Rosas -- Bulk drugs : process design, technology transfer, and first manufacture / Carlos B. Rosas -- Design and construction of API manufacturing facilities / Steven Mongiardo -- Regulatory affairs : requirements and expectations / John Curran -- Regulatory affairs : guidelines, evolving strategies, and issues / John Curran -- Validation of active pharmaceutical ingredients / James Agalloco and Phil DeSantis -- Quality of active pharmaceutical ingredients / Michael C. Vander Zwan and Carlos Yuraszeck -- Environmental control / Bruce Wallington -- Thermochemical process safety : an introduction / Carlos B. Rosas -- Design and operating practices for safety / Stanley S. Grossel -- Plant operations / Stanley H. Nusim -- Sterile bulk active pharmaceutical ingredient production / James Agalloco and Phil DeSantis -- Biological production of active pharmaceutical intermediates / Max J. Kennedy, Randolph L. Greasham, and Stephen W. Drew -- Supply management / Victor J. Catalano -- Equipment maintenance and reliability / Kaizad P. Sunavala
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| Subject
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Drug development
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Pharmaceutical technology
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Drugs-- Law and legislation
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Pharmaceutical industry
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Drug Industry-- organization administration
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Chemistry, Pharmaceutical
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| Subject
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Drug Compounding
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Legislation, Drug
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| Subject
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Legislation, Pharmacy
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| Dewey Classification
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615/.19
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| LC Classification
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RM301.25.A28 2010
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| NLM classification
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W1DR893B v.205 2009
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QV 736A188 2009
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| Added Entry
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Nusim, Stanley
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