The pharmaceutical regulatory process (Book, 2005) []
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The pharmaceutical regulatory process

Author: Ira R Berry
Publisher: New York : Marcel Dekker, 2005.
Series: Drugs and the pharmaceutical sciences, v. 144.
Edition/Format:   Print book : EnglishView all editions and formats

A tool to navigate and understand the pharmaceutical regulatory framework. Covering the procedures utilized by pharmaceutical companies for regulatory compliance, this book describes the history and  Read more...


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Material Type: Internet resource
Document Type: Book, Internet Resource
All Authors / Contributors: Ira R Berry
ISBN: 0824754646 9780824754648
OCLC Number: 57434176
Description: xiii, 711 pages : illustrations ; 25 cm.
Contents: Pharmaceutical regulation before and after the food, drug, and cosmetic act / John P. Swann --
The new drug-approval process-before and after 1962 / Michael P. Peskoe --
FDA regulation of biological products / James N. Czaban and Natasha Leskovsek --
Generic drug approval process: pre-1984 history concerning generic drugs / David L. Rosen --
Generic drug approval process, post-1984: Hatch-Waxman reform / Marc S. Gross [and others] --
Food and drug administration modernization act / Arthur Y. Tsien and Patricia E. Pahl --
FDA Antibiotic regulatory scheme: then and now / Irving L. Wiesen --
Pioneer and generic drugs: balance between product life cycle extension and anticompetitive behavior / Robert G. Pinco and Barbara A. Binzak --
The influence of the prescription drug user fee act on the approval process / Marc J. Scheineson --
Clinical research requirements for new drug applications / Gary Yingling and Ann Begly --
Active pharmaceutical ingredients / Max S. Lazar --
Obtaining approval of new drug applications and abbreviated new drug applications from a chemistry, manufacturing, and controls perspective / Dhiren N. Shah --
Obtaining approval of a generic drug / Loren Gelber --
Current good manufacturing practice and the drug approval process / Nicholas Buhay --
CMC post-approval regulatory affairs: constantly managing change / Leo J. Lucisano and Kevin A. Miller --
The influence of the USP on the drug approval process / Edward M. Cohen --
Ways and means to U.S. registration of foreign drugs / Alberto Grignolo [and others] --
Common techinical document-quality (M4-Q): one regulatory participant's perspective / Ubrani V. Venkataram --
21 CFR part 11 compliance and beyond / Richard L. Burcham --
Marketing and advertising/promotion: the impact of government regulations / Daniel Glassman, Philip W. McGinn, Jr., and Gene Goldberg --
Approval and marketing of nonprescription or OTC human drugs / William J. Mead.
Series Title: Drugs and the pharmaceutical sciences, v. 144.
Responsibility: edited by Ira R. Berry.
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