| Description |
1 online resource (xii, 215 pages) : illustrations |
| Contents |
Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier |
| Summary |
A step-by-step, integrated approach for successful, FDA-approved combination drug products Using a proven integrated approach to combination drug development, this book guides you step by step through all the preclinical, clinical, and manufa |
| Bibliography |
Includes bibliographical references and index |
| Notes |
English |
|
Print version record |
| Subject |
United States. Food and Drug Administration.
|
| SUBJECT |
United States Food and Drug Administration |
|
United States. Food and Drug Administration fast |
| Subject |
Drug approval -- United States
|
|
Biological products -- United States
|
|
Medical instruments and apparatus -- United States
|
|
HEALTH & FITNESS -- Safety.
|
|
Biological products
|
|
Drug approval
|
|
Medical instruments and apparatus
|
|
United States
|
| Form |
Electronic book
|
| Author |
Siegel, Evan B
|
| LC no. |
2008001360 |
| ISBN |
9780470371190 |
|
0470371196 |
|
9780470371077 |
|
0470371072 |
|
128138190X |
|
9781281381903 |
|
0470050942 |
|
9780470050941 |
|
9786611381905 |
|
6611381902 |
|
