Description |
1 online resource (x, 278 pages) : illustrations |
Series |
Drugs and the pharmaceutical sciences ; 181 |
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Drugs and the pharmaceutical sciences ; v. 181.
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Contents |
The evolution of the Food and Drug Administration: pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- Training requirements in product development: a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- The systems-based pre-approval inspection / Elizabeth M. Troll -- A cGMP risk assessment and management strategy: guidelines for the pre-approval inspection / Carmen Medina -- Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- Integral for successful PAI: the quality assessment program / Graham Bunn -- All dressed up but no approval to go: the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman |
Summary |
Offers a guide to prepare for inspections - taking into account, the trends in FDA expectations and enforcement activities, such as quality systems-based approach to inspections and risk-based inspections |
Notes |
Revised edition of: Preparing for FDA pre-approval inspections. ©1999 |
Bibliography |
Includes bibliographical references and index |
Notes |
Print version record |
Subject |
United States. Food and Drug Administration.
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SUBJECT |
United States. Food and Drug Administration fast |
Subject |
Drugs -- Research -- Standards -- United States
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Drug Industry -- standards
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Drug Approval
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Laboratories -- standards
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Drugs -- Research -- Standards
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SUBJECT |
United States |
Subject |
United States
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Form |
Electronic book
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Author |
Hynes, Martin D.
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ISBN |
9781420020489 |
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142002048X |
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9780849391842 |
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0849391849 |
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