An edition of The pharmaceutical regulatory process
(2004)
The pharmaceutical regulatory process
2nd ed.
by Ira R. Berry and Robert P. Martin
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1
The Pharmaceutical Regulatory Process, Second Edition (Drugs and the Pharmaceutical Sciences)
January 20, 2009, Informa Healthcare
Hardcover
in English
- 2 edition
1420070428 9781420070422
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The pharmaceutical regulatory process
2008, Informa Healthcare USA
in English
- 2nd ed.
1420070428 9781420070422
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Book Details
Table of Contents
Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann
Modernizing the Food And Drug Administration / Arthur Y. Tsien
New drug approval process : before and after 1962 / Michael P. Peskoe
Generic drug approval process : Hatch-Waxman Update / Marc S. Gross ... [et al.]
FDA regulatory process of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd
FDA'santibiotic regulatory scheme : then and now / Irving L. Wiesen
Generic drugs in a changing intellectual property landscape / Neil F. Greenblum ... [et al.]
The influence of the Prescription Drug User Fee Act on the approval process / Marc J. Scheineson
Clinical research requirements for new drug applications / Gary L. Yingling
Post-approval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin
Drugs marketed without FDA approval / Jane Baluss and David Rosen
Legal issues surrounding the importation of foreign APIs / England
Active pharmaceutical ingredients / Max S. Lazar
Obtaining approval of NDAs and ANDAs from a chemistry, manufacturing, and controls perspective / Shah
Obtaining approval of a generic drug : pre- 1984 to present / Loren Gelber
New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead
Current good manufacturing process and the drug approval process / Ira R. Berry
The influence of the USP on the drug approval process / Edward M. Cohen
Ways, means, and evolving trends in the U.S. registration of drug products from foreign countries / Alberto Grignolo
Impact of government regulation on prescription drug marketing and promotion / Daniel Glassman, Gene Goldberg, and Barbara Spallitta
CMC post-approval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour
Living with 21 CFR part 11 compliance / Richard L. Burcham.
Edition Notes
Includes bibliographical references and index.
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| February 3, 2023 | Edited by ImportBot | import existing book |
| November 23, 2021 | Edited by JimmanBot | Removed duplicate olid of author |
| August 14, 2020 | Edited by ImportBot | import existing book |
| July 28, 2014 | Created by ImportBot | import new book |