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|a 101485457
|2 DNLM
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|a 9780367202842
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|a 9781420070422 (hardcover : alk. paper)
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|a 344.7304233
|2 23
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4 |
|a The pharmaceutical regulatory process /
|c edited by Ira R. Berry, Robert P. Martin.
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| 260 |
|
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|a New York :
|b Informa Healthcare,
|c c2008 [reprinted 2022].
|
| 300 |
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|a x, 469 pages :
|b illustrations ;
|c 24 cm.
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| 490 |
1 |
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|a Drugs and the pharmaceutical sciences ;
|v 185
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| 504 |
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|a Includes bibliographical references and index.
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| 505 |
0 |
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|a 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.
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| 505 |
0 |
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|a 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.
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| 526 |
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|a PHR
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|a Paragon Enterprises LTD
|e 39349, 39350, 39351, 39352, 39353, 39354
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| 650 |
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|a Pharmacy
|x Law and legislation
|z United States.
|9 50825
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| 650 |
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|a Drugs
|x Law and legislation
|z United States.
|9 50826
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| 650 |
1 |
2 |
|a Legislation, Drug
|z United States.
|9 50827
|
| 650 |
2 |
2 |
|a Guideline Adherence
|x legislation & jurisprudence
|z United States.
|9 50828
|
| 650 |
2 |
2 |
|a Pharmaceutical Preparations
|x standards
|z United States.
|9 50829
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| 650 |
2 |
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|a Pharmacy.
|9 50830
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| 700 |
1 |
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|a Berry, Ira R.,
|d 1942-
|9 50831
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| 700 |
1 |
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|a Martin, Robert P.
|q (Robert Paul)
|9 50832
|
| 830 |
|
0 |
|a Drugs and the pharmaceutical sciences ;
|v v. 185.
|9 50833
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| 852 |
|
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|a Ayesha Abed Library
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