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FINmELB |
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20200520144314.0 |
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m o d | |
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cr cn||||||||| |
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080110s2008 njua sb 001 0 eng |
| 016 |
7 |
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|z 101463351
|2 DNLM
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| 020 |
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|z 9780470050941 (hbk.)
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| 035 |
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|a (OCoLC)190867380
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| 040 |
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|a FINmELB
|c FINmELB
|d FINmELB
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| 043 |
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|a n-us---
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| 050 |
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4 |
|a RA401.5
|b .D48 2008
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| 082 |
0 |
4 |
|a 363.19/46
|2 22
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| 245 |
0 |
0 |
|a Development and approval of combination products
|h [electronic resource] :
|b a regulatory perspective /
|c edited by Evan B. Siegel.
|
| 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.
|
| 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.
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| 588 |
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|a Description based on metadata supplied by the publisher and other sources.
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| 590 |
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|a Electronic reproduction. Santa Fe, Arg.: elibro, 2021. Available via World Wide Web. Access may be limited to eLibro affiliated libraries.
|
| 610 |
1 |
0 |
|a United States.
|b Food and Drug Administration.
|
| 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.
|
| 655 |
|
4 |
|a Electronic books.
|
| 700 |
1 |
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|a Siegel, Evan B.
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| 797 |
2 |
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|a elibro, Corp.
|
| 856 |
4 |
0 |
|u https://elibro.uam.elogim.com/ereader/bidiuam/177758
|z Texto completo
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| 950 |
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|a eLibro English
|
