Pharmaceutical pre-approval inspections : a guide to regulatory success /: a guide to regulatory success. (©2008)

• Record Type: Book
• Uniform Title: Preparing for FDA pre-approval inspections.
• Further Information: Note: Edited by Martin D. Hynes III.
• Other Names: Hynes, Martin D
• 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.
• Edition: 2nd ed
• Publisher Details: New York : Informa Healthcare
• Publication Date: 2008
• Copyright Date: 2008
• Extent: 1 online resource (x, 278 pages), illustrations
• Subjects: 615/.19; Drugs -- Research -- Standards -- United States; Drug Industry -- standards; Drug Approval; Laboratories -- standards; Drugs; Médicaments -- Recherche -- Normes -- États-Unis; MEDICAL -- Drug Guides; MEDICAL -- Pharmacology; MEDICAL -- Pharmacy; MEDICAL -- Nursing -- Pharmacology; Drugs -- Research -- Standards; United States; United States; Electronic books
• Languages: English
• ISBNs: 9781420020489; 9780849391842; 0849391849
• Related ISBNs: 142002048X
• Notes: Note: Includes bibliographical references and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.