The pharmaceutical regulatory process - Berry, Ira R., 1942-; Martin, Robert P. (Robert Paul) (New York : Informa Healthcare, 2008)
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.
Includes bibliographical references and index.
PHR
Keywords: Pharmacy -- Law and legislation -- United States; Drugs -- Law and legislation -- United States; Legislation, Drug -- United States; Guideline Adherence -- legislation & jurisprudence -- United States; Pharmaceutical Preparations -- standards -- United States; Pharmacy