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The pharmaceutical regulatory process

Ira R Berry 1942-; Robert P Martin (Robert Paul)

New York Informa Healthcare c2008

Localização: CQ - Conjunto das Químicas    (615.026 P536 2008 )(Acessar)

  • Título:
    The pharmaceutical regulatory process
  • Autor: Ira R Berry 1942-; Robert P Martin (Robert Paul)
  • Assuntos: Pharmacy -- Law and legislation -- United States; Drugs -- Law and legislation -- United States; LEGISLAÇÃO FARMACÊUTICA; FÁRMACOS (LEGISLAÇÃO); Legislation, Drug -- United States; Guideline Adherence -- legislation & jurisprudence -- United States; Pharmaceutical Preparations -- standards -- United States
  • Notas: Includes bibliographical references and index
  • Descrição: 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.
  • Títulos relacionados: Série:Drugs and the pharmaceutical sciences v. 185
  • Editor: New York Informa Healthcare
  • Data de criação/publicação: c2008
  • Formato: x, 469 p ill 24 cm.
  • Idioma: Inglês
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  • Realização: ABCD-USP USP   Logos de Redes Sociais: Freepik

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