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00000cam a2200000 7i4500 |
| 001 |
0000093732 |
| 005 |
20200728093000.0 |
| 008 |
170601s2016 flu eng |
| 020 |
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|a 9781498743471
|
| 040 |
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|a UniSZA
|e rda
|
| 050 |
0 |
0 |
|a RS380
|b .N53 2016
|
| 060 |
1 |
0 |
|a QV 241
|b .N577 2016
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| 090 |
0 |
0 |
|a RS380
|b .N53 2016
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| 100 |
1 |
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|a Niazi, Sarfaraz ,
|d 1949- ,
|e author
|
| 245 |
1 |
0 |
|a Biosimilars and interchangeable biologics :
|b strategic elements
|c Sarfaraz K. Niazi
|
| 264 |
|
1 |
|a Boca Raton, Florida :
|b CRC Press
|c c2016
|
| 300 |
|
|
|a xlv, 599 pages :
|b illustration ;
|c 29 cm.
|
| 336 |
|
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|a text
|2 rdacontent
|
| 337 |
|
|
|a unmediated
|2 rdamedia
|
| 338 |
|
|
|a volume
|2 rdacarrier
|
| 504 |
|
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|a Includes bibliographical references and index
|
| 505 |
0 |
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|a 1. Introduction to biosimilar and interchangeable products -- 2. Intellectual property issues -- 3. The EMA regulatory guidance -- 4. EMA approved biosimilars -- 5. The FDA regulatory guidance -- 6. The ROW regulatory guidance -- 7. US commercialization -- 8. Global commercialization -- 9. Quality and lifecycle management
|
| 650 |
1 |
2 |
|a Biosimilar Pharmaceuticals
|x Standards
|
| 650 |
2 |
2 |
|a Drug Approval
|
| 650 |
2 |
2 |
|a Drug Discovery
|x Standards
|
| 650 |
2 |
2 |
|a Drug Evaluation
|x Standards
|
| 650 |
2 |
2 |
|a Drug Industry
|x Standards
|
| 999 |
|
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|a 1000169255
|b Book
|c OPEN SHELF (30 DAYS)
|e Tembila Campus
|