Active pharmaceutical ingredients : development, manufacturing, and regulation /: development, manufacturing, and regulation. ([2010])

• Record Type: Book
• Further Information: Note: Edited by Stanley H. Nusim.
• Other Names: Nusim, Stanley
• Contents: 1. Introduction / Stanley H. Nusim -- 2. Bulk drugs : the process development task / Carlos B. Rosas -- 3. Bulk drugs : process design, technology transfer, and first manufacture / Carlos B. Rosas -- 4. Design and construction of API manufacturing facilities / Steven Mongiardo -- 5. Regulatory affairs : requirements and expectations / John Curran -- 6. Regulatory affairs : guidelines, evolving strategies, and issues / John Curran -- 7. Validation of active pharmaceutical ingredients / James Agalloco and Phil DeSantis -- 8. Quality of active pharmaceutical ingredients / Michael C. Vander Zwan and Carlos Yuraszeck -- 9. Environmental control / Bruce Wallington -- 10. Thermochemical process safety : an introduction / Carlos B. Rosas -- 11. Design and operating practices for safety / Stanley S. Grossel -- 12. Plant operations / Stanley H. Nusim -- 13. Sterile bulk active pharmaceutical ingredient production / James Agalloco and Phil DeSantis -- 14. Biological production of active pharmaceutical intermediates / Max J. Kennedy, Randolph L. Greasham, and Stephen W. Drew -- 15. Supply management / Victor J. Catalano -- 16. Equipment maintenance and reliability / Kaizad P. Sunavala.
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2010
• Copyright Date: 2010
• Extent: 1 online resource (452 pages)
• Subjects: 615/.19; Drug development; Pharmaceutical technology; Drugs -- Law and legislation; Pharmaceutical industry; Chemistry, Pharmaceutical; Drug Compounding; Drug development; Drug Industry -- organization & administration; Drugs -- Law and legislation; Legislation, Drug; Legislation, Pharmacy; Pharmaceutical industry; Pharmaceutical technology; MEDICAL -- Pharmacology; Drug development; Drugs -- Law and legislation; Pharmaceutical industry; Pharmaceutical technology; Electronic books
• Languages: English
• ISBNs: 9781439803394; 1439803390
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.