TY  - BOOK
AU  - Berry,Ira R.
AU  - Martin,Robert P.
TI  - The pharmaceutical regulatory process
T2  - Drugs and the pharmaceutical sciences
SN  - 9781420070439 (ebk.)
U1  - 344.7304/233 22
PY  - 2008///
CY  - New York
PB  - Informa Healthcare
KW  - Pharmacy
KW  - Law and legislation
KW  - United States
KW  - Drugs
KW  - Electronic books
N1  - 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
UR  - https://ezproxy.taylors.edu.my/login?url=http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=260345
ER  -