| Document Type
|
:
|
BL
|
| Record Number
|
:
|
699616
|
| Doc. No
|
:
|
b521805
|
| Title & Author
|
:
|
Pharmaceutical pre-approval inspections : : a guide to regulatory success /\ edited by Martin D. Hynes III
|
| Edition Statement
|
:
|
2nd ed
|
| Publication Statement
|
:
|
New York :: Informa Healthcare,, c2008
|
| Series Statement
|
:
|
Drugs and the pharmaceutical sciences ;
|
| Page. NO
|
:
|
x, 278 p. :: ill. ;; 24 cm
|
| ISBN
|
:
|
0849391849 (hardcover : alk. paper)
|
|
|
:
|
: 9780849391842 (hardcover : alk. paper)
|
| Notes
|
:
|
Rev. ed. of: Preparing for FDA pre-approval inspections. c1999
|
| Bibliographies/Indexes
|
:
|
Includes bibliographical references and index
|
| 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
|
| Subject
|
:
|
United States.
|
|
|
:
|
United States.
|
| Subject
|
:
|
Drugs-- Research-- Standards-- United States
|
| Subject
|
:
|
Drug Approval-- United States
|
| Subject
|
:
|
Laboratories-- standards-- United States
|
| Dewey Classification
|
:
|
615/.19
|
| LC Classification
|
:
|
RM301.27.P74 2008
|
| NLM classification
|
:
|
QV 736P53616 2008
|
|
|
:
|
W1DR893B v.181 2008
|
| Added Entry
|
:
|
Hynes, Martin D
|