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| LEADER |
02129cam a22002654a 4500 |
| 020 |
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|a 9781420073546
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| 082 |
0 |
0 |
|a 615.19
|b P81
|
| 245 |
0 |
0 |
|a FDA regulatory affairs:
|b a guide for prescription drugs, medical devices, and biologics/
|c Ed by Douglas J. Pisano, David S. Mantus.
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| 250 |
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|a 2nd ed.
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| 260 |
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|a New York:
|b Informa Healthcare USA,
|c 2008.
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| 300 |
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|a viii, 448 p.
|b ill.
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| 504 |
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|a Includes bibliographical references and index.
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| 505 |
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|a Overview of FDA and drug development / Josephine C. Babiarz and Douglas J. Pisano -- What is an IND / Charles Monahan and Josephine C. Babiarz -- Meeting with the FDA / Alberto Grignolo -- FDA medical device regulation / Barry Sall -- The development of orphan drugs / Tan T. Nguyen -- CMC sections of regulatory filings and CMC regulatory compliance during investigational and postapproval states / Prabu Nambiar and Steven R. Koepke -- Overview of the GxPs for the regulatory professional / Bob Buckley and Robert Blanks -- FDA regulation of the advertising and promotion of prescription drugs, biologics, and medical devices / Karen L. Drake -- Electronic submissions--a guide for electronic regulatory submissions to FDA / Shylendra Kumar, Yolanda Hall, and Vahé Ghahraman -- The practice of regulatory affairs / David S. Mantus -- A primer of drug/device law : what's the law and how do I find it / Josephine C. Babiarz -- FDA advisory committees / Christina A. McCarthy and David S. Mantus -- Biologics / Timothy A. Keutzer.
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| 650 |
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0 |
|a Drug development-United States.
|9 8183
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| 650 |
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0 |
|a Pharmaceutical industry-United States.
|9 8184
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| 650 |
1 |
2 |
|a Drug Industry-United States.
|9 8185
|
| 650 |
1 |
2 |
|a United States Government Agencies
|9 8186
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| 650 |
2 |
2 |
|a Biological Products-United States.
|9 8187
|
| 650 |
2 |
2 |
|a Equipment and Supplies-United States.
|9 8188
|
| 650 |
2 |
2 |
|a Government Regulation-United States.
|9 8189
|
| 700 |
1 |
|
|a Pisano, Douglas J, Ed
|9 8220
|
| 700 |
1 |
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|a Mantus, David, Ed
|9 8221
|
| 942 |
|
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|c BK
|
| 999 |
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|c 61726
|d 61726
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| 952 |
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|a MGUL
|b MGUL
|c GEN
|d 2014-06-21
|l 0
|o 615.19 P81
|p 49840
|r 2014-06-21
|w 2014-06-21
|y BK
|