| 000 | 02484nam a2200505Ii 4500 | ||
|---|---|---|---|
| 001 | 9781315368344 | ||
| 003 | FlBoTFG | ||
| 005 | 20220509192936.0 | ||
| 006 | m o d | ||
| 007 | cr | ||
| 008 | 181112t20182017fluab ob 001 0 eng d | ||
| 020 |
_a9781315368344 _q(e-book : PDF) |
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| 035 | _a(OCoLC)1057341765 | ||
| 040 |
_aFlBoTFG _cFlBoTFG _erda |
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| 041 | 1 | _aeng | |
| 050 | 4 |
_aRS67.U6 _bN539 2018 |
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| 072 | 7 |
_aMED _x009000 _2bisacsh |
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| 072 | 7 |
_aMED _x071000 _2bisacsh |
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| 072 | 7 |
_aTDCW _2bicscc |
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| 082 | 0 | 4 | _a615.10973 |
| 100 | 1 |
_aNiazi, Sarfaraz K., _eauthor. |
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| 245 | 1 | 0 |
_aBiosimilarity : _bThe FDA Perspective / _cby Sarfaraz K. Niazi. |
| 250 | _aFirst edition. | ||
| 264 | 1 |
_aBoca Raton, FL : _bCRC Press, _c[2018]. |
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| 264 | 4 | _c©2017. | |
| 300 |
_a1 online resource (436 pages) : _b79 illustrations, text file, PDF |
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| 336 |
_atext _2rdacontent |
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| 337 |
_acomputer _2rdamedia |
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| 338 |
_aonline resource _2rdacarrier |
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| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | 0 | _tCurrent Status of Biosimilar Biological Products. The FDA Position. Biosimilarity Tetrahedron. Analytical and Functionality Similarity. Non-clinical Assessment. Clinical Pharmacology Assessment. Clinical Studies. Interchangeability Status. Comprehensive Presentation |
| 520 | 3 | _aThe focus of this book is on how the US FDA will approve biosimilar drugs. The European scene is well developed with specific guidelines that are already in place. However, these guidelines do not apply to the thinking of the FDA in approving these products. The FDA is quite different from other regulatory agencies. With the US providing more than 50% of the worldwide market for these products, every serious manufacturer of biosimilar biological drugs should be targeting US approval of their products. Thus, this book is strictly on FDA approval strategy. | |
| 530 | _aAlso available in print format. | ||
| 650 | 0 |
_aDrugs _xGeneric substitution. |
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| 650 | 0 |
_aPharmaceutical biotechnology _zUnited States. |
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| 650 | 0 | _aPharmaceutical biotechnology. | |
| 650 | 0 | _aBiosimilar Pharmaceuticals. | |
| 650 | 0 | _aDrug Approval. | |
| 650 | 0 | _aGovernment Regulation. | |
| 650 | 0 | _aUnited States Government Agencies. | |
| 650 | 7 |
_aMEDICAL / Pharmacology. _2bisacsh |
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| 655 | 0 | _aElectronic books. | |
| 710 | 2 | _aTaylor and Francis. | |
| 776 | 0 | 8 |
_iPrint version: _z9781498750394 |
| 856 | 4 | 0 |
_uhttps://www.taylorfrancis.com/books/9781315368344 _zClick here to view. |
| 999 |
_c126969 _d126969 |
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