New drug approval process : accelerating global registrations / edited by Richard A. Guarino, M.D., oxford pharmaceutical resources, inc., Totowa, New Jersey, U.S.A.
Material type:
TextSeries: Drugs and the pharmaceutical sciencesPublisher: New York : Marcel Dekker Inc., [2004]Copyright date: ©2004Edition: Fourth editionDescription: xiv, 635 pages : illustrations (black and white) ; 24 cmContent type: - text
- unmediated
- volume
- 0824750411
- Drug approval -- United States
- Drugs -- Testing -- Standards
- Drugs -- Testing -- Government policy -- United States
- New products -- Government policy -- United States
- Clinical Trials as Topic -- standards -- United States
- Drug Evaluation -- standards -- United States
- Drug Approval -- standards -- United States
- 22 615.1 N.
| Item type | Current library | Collection | Call number | Status | Date due | Barcode | |
|---|---|---|---|---|---|---|---|
Books
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Main library A10 | Pharmacy ( Clinical Pharmacy ) | 615.1 N. (Browse shelf(Opens below)) | Available | 00016399 |
Includes bibliographical references and index
pt. 1. Regulatory practices and procedures of new drug, biologic, and device development --
pt. 2. Clinical research development --
pt. 3. Specific aspects in the process of new product submissions --
pt. 4. Global applications of good clinical practices (GCPs) --
pt. 5. Effective and new methodologies in expediting new product approvals in the U.S. and European Union.
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