Active pharmaceutical ingredients : development, manufacturing, and regulation /
Active pharmaceutical ingredients : development, manufacturing, and regulation /
- 2nd ed.
- New York : Informa Healthcare, c2010.
- xv, 433 p. : ill. ; 24 cm.
- Drugs and the pharmaceutical sciences ; 205 .
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.
9781439803363 (hb : alk. paper) 9781439803363 1439803366 (hb : alk. paper) 1438003366 (hb : alk. paper) 9781438003368 (hb : alk. paper)
Drug development.
Pharmaceutical technology.
Drugs--Law and legislation.
Pharmaceutical industry.
615.19 / NUS
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.
9781439803363 (hb : alk. paper) 9781439803363 1439803366 (hb : alk. paper) 1438003366 (hb : alk. paper) 9781438003368 (hb : alk. paper)
Drug development.
Pharmaceutical technology.
Drugs--Law and legislation.
Pharmaceutical industry.
615.19 / NUS