Preparing for FDA pre-approval inspections / edited by Martin D. Hynes, III.
Material type:
TextSeries: Drugs and the pharmaceutical sciencesPublisher: New York : Marcel Dekker Inc., [1999]Copyright date: ©1999Description: ix, 284 pages : illustrations ; 24 cmContent type: - text
- unmediated
- volume
- 0824702182 (alk. paper)
- 615.19 22 P.
- RM301.27 .P74 1999
| Item type | Current library | Collection | Call number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|
Books
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Main library A10 | Pharmacy ( Clinical Pharmacy ) | 615.19 P. (Browse shelf(Opens below)) | Available | 00016403 |
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Includes bibliographical references and index.
Introduction to the Food and Drug Administration Pre-New Drug Applications Approval Inspections o Developing a Strategic Approach to Preparing for a Successful Pre-NDA Approval Inspection o Food and Drug Administration International Pre-Approval Inspections o Stability Data and Pre-Approval Inspections o Consequences of Failing a Pre-Approval Inspection o Successful Management of a Pre-Approval Inspection o The Validation of Pharmaceutical Processes o Documentation Standards for Pre-Approval Inspections o Technology Transfer and Scale-up o Training of Personnel in the Pharmaceutical Industry o Compliance with Current Good Manufacturing Practices and Application Commitments
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