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Active pharmaceutical ingredients : development, manufacturing, and regulation /

Contributor(s): Nusim, Stanley.
Series: Drugs and the pharmaceutical sciences ; 205.Publisher: New York : Informa Healthcare, c2010Edition: 2nd ed.Description: xv, 433 p. : ill. ; 24 cm.Content type: text Media type: unmediated Carrier type: volumeISBN: 9781439803363 (hb : alk. paper); 9781439803363; 1439803366 (hb : alk. paper); 1438003366 (hb : alk. paper); 9781438003368 (hb : alk. paper).Subject(s): Drug development | Pharmaceutical technology | Drugs -- Law and legislation | Pharmaceutical industryDDC classification: 615.19
Contents:
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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Holdings
Item type Current library Call number Copy number Status Date due Barcode Item holds
Standard Loan Standard Loan ATU Sligo Yeats Library Main Lending Collection 615.19 NUS (Browse shelf(Opens below)) 1 Missing 0059954
Total holds: 0

Includes bibliographical references and index.

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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