The pharmaceutical regulatory process / edited by Ira R. Berry, Robert P. Martin.
Material type: TextSeries: Drugs and the pharmaceutical sciences ; v. 185.Publication details: New York : Informa Healthcare, c2008 [reprinted 2022].Description: x, 469 pages : illustrations ; 24 cmISBN:- 9780367202842
- 9781420070422 (hardcover : alk. paper)
- 344.7304233 23
Item type | Current library | Home library | Call number | Copy number | Status | Date due | Barcode | Item holds |
---|---|---|---|---|---|---|---|---|
Book | Ayesha Abed Library General Stacks | Ayesha Abed Library General Stacks | 344.7304233 PHA (Browse shelf(Opens below)) | 1 | Available | 3010039349 | ||
Book | Ayesha Abed Library General Stacks | Ayesha Abed Library General Stacks | 344.7304233 PHA (Browse shelf(Opens below)) | 2 | Available | 3010039350 | ||
Book | Ayesha Abed Library General Stacks | Ayesha Abed Library General Stacks | 344.7304233 PHA (Browse shelf(Opens below)) | 3 | Available | 3010039351 | ||
Book | Ayesha Abed Library General Stacks | Ayesha Abed Library General Stacks | 344.7304233 PHA (Browse shelf(Opens below)) | 4 | Available | 3010039352 | ||
Book | Ayesha Abed Library General Stacks | Ayesha Abed Library General Stacks | 344.7304233 PHA (Browse shelf(Opens below)) | 5 | Available | 3010039353 | ||
Book | Ayesha Abed Library General Stacks | Ayesha Abed Library General Stacks | 344.7304233 PHA (Browse shelf(Opens below)) | 6 | Available | 3010039354 |
Includes bibliographical references and index.
Pharmaceutical regulation before and after the Food, Drug, and Cosmetic Act / John P. Swann -- Modernizing the Food And Drug Administration / Arthur Y. Tsien -- The new drug approval- process - before and after 1962 / Michael P. Peskoe -- Generic drug-approval process - Hatch-Waxman update / Marc S. Gross ... [et al.] -- FDA regulation of biological products / Michael S. Labson, Krista Hessler Carver, and Marie C. Boyd -- FDA's antibiotic 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 and Ann M. Begley -- Postapproval marketing practices regarding drug safety and pharmacovigilance / Robert P. Martin -- Drugs marketed without FDA approval / Jane Baluss and David Rosen -- FDA regulation of foreign drug imports : the need for improvement / Benjamin L. England.
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, pre-1984 to the present / Loren Gelber -- New developments in the approval and marketing of nonprescription or OTC drugs / William J. Mead -- Current good manufacturing practice 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 postapproval regulatory affairs : constantly managing change / Leo J. Lucisano, Kevin A. Miller, and Lorien Armour -- Living with 21 CFR part 11 compliance / Richard L. Burcham.
PHR
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