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Active pharmaceutical ingredients = ...

Nusim, Stanley.

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Active pharmaceutical ingredients = development, manufacturing, and regulation /

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	Active pharmaceutical ingredients/ edited by Stanley H. Nusim.
其他題名:	development, manufacturing, and regulation /
其他作者:	Nusim, Stanley.
出版者:	New York :Informa Healthcare, : c2010.,
面頁冊數:	xv, 433 p. :ill.
內容註:	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.
標題:	Drug development. -
電子資源:	http://marc.crcnetbase.com/isbn/9781439803394Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781439803394 (ebook : PDF)

Active pharmaceutical ingredients = development, manufacturing, and regulation /
Active pharmaceutical ingredientsdevelopment, manufacturing, and regulation /[electronic resource] :edited by Stanley H. Nusim. - 2nd ed. - New York :Informa Healthcare,c2010. - xv, 433 p. :ill. - Drugs and the pharmaceutical sciences ;205. - Drugs and the pharmaceutical sciences ;v. 183-184.

Includes bibliographical references and index.

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.

Mode of access: World Wide Web.

ISBN: 9781439803394 (ebook : PDF)Subjects--Topical Terms:

716904
Drug development.
Index Terms--Genre/Form:

542853
Electronic books.

Active pharmaceutical ingredients = development, manufacturing, and regulation /
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090 $a RM301.25 $b .A28 2010
092 $a 615.19 $b A188
245 0 0 $a Active pharmaceutical ingredients $h [electronic resource] : $b development, manufacturing, and regulation / $c edited by Stanley H. Nusim.
250 $a 2nd ed.
260 $a New York : $b Informa Healthcare, $c c2010.
300 $a xv, 433 p. : $b ill.
490 1 $a Drugs and the pharmaceutical sciences ; $v 205
504 $a Includes bibliographical references and index.
505 0 $a 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.
530 $a Also available in print edition.
538 $a Mode of access: World Wide Web.
650 0 $a Drug development. $3 716904
650 0 $a Pharmaceutical technology. $3 562441
650 0 $a Drugs $x Law and legislation. $3 813948
650 0 $a Pharmaceutical industry. $3 630829
655 7 $a Electronic books. $2 lcsh $3 542853
700 1 $a Nusim, Stanley. $3 916281
776 1 $z 9781439803363 (hardback : alk. paper) $z 1439803366 (hardback : alk. paper) $z 1438003366 (hardback : alk. paper) $z 9781438003368 (hardback : alk. paper)
830 0 $a Drugs and the pharmaceutical sciences ; $v v. 183-184 $3 1359366
856 4 0 $u http://marc.crcnetbase.com/isbn/9781439803394 $q application/PDF $z Distributed by publisher. Purchase or institutional license may be required for access.