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![](/opac-tmpl/bootstrap/images/filefind.png)
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Item type | Current library | Call number | Copy number | Status | Date due | Barcode | Item holds |
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ATU Sligo Yeats Library Main Lending Collection | 615.19 NUS (Browse shelf(Opens below)) | 1 | Missing | 0059954 |
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.