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The pharmaceutical regulatory process

Berry, Ira R., (1942-)

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The pharmaceutical regulatory process

紀錄類型:	書目-電子資源 : Monograph/item
正題名/作者:	The pharmaceutical regulatory process/ edited by Ira R. Berry, Robert P. Martin.
其他作者:	Berry, Ira R.,
出版者:	New York :Informa Healthcare, : c2008.,
面頁冊數:	x, 469 p. :ill.
內容註:	1. Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- 2. Modernizing the Food And Drug Administration / Arthur Y. Tsien -- 3. The new drug-approval process : before and after 1962 / Michael P. Peskoe -- 4. Generic drug-approval process : Hatch-Waxman update / Marc S. Gross ... [et al.] -- 5. FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- 6. FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- 7. Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- 8. The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- 9. Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- 10. Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- 11. Drugs marketed without FDA approval / Jane Baluss and David Rosen -- 12. FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England --
內容註:	13. Active pharmaceutical ingredients / Max S. Lazar -- 14. Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- 15. Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber -- 16. New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- 17. Current good manufacturing practice and the drug approval process / Ira R. Berry -- 18. The influence of the USP on the drug approval process / Edward M. Cohen -- 19. Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- 20. Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- 21. CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- 22. Living with 21 CFR part 11 compliance / Richard L. Burcham.
標題:	Pharmacy - Law and legislation - United States. -
電子資源:	http://marc.crcnetbase.com/isbn/9781420070439Distributed by publisher. Purchase or institutional license may be required for access.
ISBN:	9781420070439 (ebook : PDF)

The pharmaceutical regulatory process
The pharmaceutical regulatory process[electronic resource] /edited by Ira R. Berry, Robert P. Martin. - 2nd ed. - New York :Informa Healthcare,c2008. - x, 469 p. :ill. - Drugs and the pharmaceutical sciences ;185. - Drugs and the pharmaceutical sciences ;v. 183-184.

Includes bibliographical references and index.

1. Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- 2. Modernizing the Food And Drug Administration / Arthur Y. Tsien -- 3. The new drug-approval process : before and after 1962 / Michael P. Peskoe -- 4. Generic drug-approval process : Hatch-Waxman update / Marc S. Gross ... [et al.] -- 5. FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- 6. FDA's antibiotic regulatory scheme : then and now / Irving L. Wiesen -- 7. Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.] -- 8. The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson -- 9. Clinical research requirements for new drug applications / Gary L. Yingling and Ann M. Begley -- 10. Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- 11. Drugs marketed without FDA approval / Jane Baluss and David Rosen -- 12. FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England --

Mode of access: World Wide Web.

ISBN: 9781420070439 (ebook : PDF)Subjects--Topical Terms:

916425
Pharmacy
--Law and legislation--United States.Index Terms--Genre/Form:

542853
Electronic books.

The pharmaceutical regulatory process
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490 1 $a Drugs and the pharmaceutical sciences ; $v 185
504 $a Includes bibliographical references and index.
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505 0 $a 13. Active pharmaceutical ingredients / Max S. Lazar -- 14. Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah -- 15. Obtaining approval of a generic drug, pre-1984 to the present / Loren Gelber -- 16. New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- 17. Current good manufacturing practice and the drug approval process / Ira R. Berry -- 18. The influence of the USP on the drug approval process / Edward M. Cohen -- 19. Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo -- 20. Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta -- 21. CMC postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- 22. Living with 21 CFR part 11 compliance / Richard L. Burcham.
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