Active pharmaceutical ingredients
Subtitle: development, manufacturing, and regulation
By: edited by Stanley H. Nusim
Edition: 2nd ed.
Series: Drugs and the pharmaceutical sciences -- 205; Drugs and the pharmaceutical sciences -- v. 205.
Publisher: Informa Healthcare
Published: 2010
Place of publication: New York
Language: eng
Number of pages: 433
ISBN-13: 9781439803363; 9781438003368
Notes: Includes bibliographical references and index.
Table of contents: title: Bulk drugs : the process development task / Carlos B. Rosas; title: Bulk drugs : process design, technology transfer, and first manufacture / Carlos B. Rosas; title: Design and construction of API manufacturing facilities / Steven Mongiardo; title: Regulatory affairs : requirements and expectations / John Curran; title: Regulatory affairs : guidelines, evolving strategies, and issues / John Curran; title: Validation of active pharmaceutical ingredients / James Agalloco and Phil DeSantis; title: Quality of active pharmaceutical ingredients / Michael C. Vander Zwan and Carlos Yuraszeck; title: Environmental control / Bruce Wallington; title: Thermochemical process safety : an introduction / Carlos B. Rosas; title: Design and operating practices for safety / Stanley S. Grossel; title: Plant operations / Stanley H. Nusim; title: Sterile bulk active pharmaceutical ingredient production / James Agalloco and Phil DeSantis; title: Biological production of active pharmaceutical intermediates / Max J. Kennedy, Randolph L. Greasham, and Stephen W. Drew; title: Supply management / Victor J. Catalano; title: Equipment maintenance and reliability / Kaizad P. Sunavala.