New drug approval process : accelerating global registrations /
| Other Authors: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York :
M. Dekker,
[2004]
|
| Edition: | Fourth edition. |
| Series: | Drugs and the pharmaceutical sciences ;
v.139. |
| Subjects: |
Table of Contents:
- pt. I. Regulatory practices and procedures of new drug, biologic, and device development
- pt. II. Clinical research development
- pt. III. Specific aspects in the process of new product submissions
- pt. IV. Global applications of good clinical practices (GCPs)
- pt. V. Effective and new methodologies in expediting new product approvals in the U.S. and European Union