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- 2008042661 contributor B11122440.
- 2008042661 created "c2008.".
- 2008042661 date "2008".
- 2008042661 date "c2008.".
- 2008042661 dateCopyrighted "c2008.".
- 2008042661 description "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.".
- 2008042661 description "Includes bibliographical references and index.".
- 2008042661 description "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.".
- 2008042661 extent "x, 469 p. :".
- 2008042661 identifier "1420070428 (hardcover : alk. paper)".
- 2008042661 identifier "9781420070422 (hardcover : alk. paper)".
- 2008042661 isPartOf "Drugs and the pharmaceutical sciences ; 185".
- 2008042661 isPartOf "Drugs and the pharmaceutical sciences ; v. 185.".
- 2008042661 issued "2008".
- 2008042661 issued "c2008.".
- 2008042661 language "eng".
- 2008042661 publisher "New York : Informa Healthcare,".
- 2008042661 spatial "United States.".
- 2008042661 subject "344.7304/233 22".
- 2008042661 subject "Drugs Law and legislation United States.".
- 2008042661 subject "Guideline Adherence legislation & jurisprudence United States.".
- 2008042661 subject "KF2036.D7 P47 2008".
- 2008042661 subject "Legislation, Drug United States.".
- 2008042661 subject "Pharmaceutical Preparations standards United States.".
- 2008042661 subject "Pharmacy Law and legislation United States.".
- 2008042661 subject "QV 33 AA1 P5365 2008".
- 2008042661 subject "W1 DR893B v.185 2008".
- 2008042661 tableOfContents "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.".
- 2008042661 tableOfContents "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.".
- 2008042661 title "The pharmaceutical regulatory process / edited by Ira R. Berry, Robert P. Martin.".
- 2008042661 type "text".