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01395nam a2200241 a 4500 |
| 001 |
1793433 |
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20171111234540.0 |
| 008 |
080110s2008 njua sb 001 0 eng |
| 020 |
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|z 9780470050941 (hbk.)
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| 040 |
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|a CaPaEBR
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| 050 |
1 |
4 |
|a RA401.5
|b .D48 2008eb
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| 245 |
0 |
0 |
|a Development and approval of combination products
|b a regulatory perspective /
|c edited by Evan B. Siegel.
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| 260 |
|
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|a Hoboken, N.J. :
|b Wiley,
|c c2008.
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| 300 |
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|a xii, 215 p. :
|b ill.
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| 504 |
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|a Includes bibliographical references and index.
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| 505 |
0 |
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|a 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.
|
| 650 |
|
0 |
|a Drug approval
|z United States.
|
| 650 |
|
0 |
|a Biological products
|z United States.
|
| 650 |
|
0 |
|a Medical instruments and apparatus
|z United States.
|
| 700 |
1 |
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|a Siegel, Evan B.
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| 710 |
2 |
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|a ebrary, Inc.
|
| 856 |
4 |
0 |
|u http://site.ebrary.com/lib/ucy/Doc?id=10296672
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| 952 |
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|a CY-NiOUC
|b 5a0458826c5ad14ac1ed16d5
|c 998a
|d 945l
|e -
|t 1
|x m
|z Books
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