یادداشتهای مربوط به کتابنامه ، واژه نامه و نمایه های داخل اثر
متن يادداشت
Includes bibliographical references and index
یادداشتهای مربوط به مندرجات
متن يادداشت
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