| 000 | 02303cam a2200325 a 4500 | ||
|---|---|---|---|
| 999 |
_c7296 _d7296 |
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| 001 | 17326574 | ||
| 005 | 20190512133603.0 | ||
| 008 | 120531s2012 flua bf 001 0 eng | ||
| 010 | _a 2012022035 | ||
| 020 | _a9780824706890 (hardback : acidfree paper) | ||
| 040 |
_aDLC _cDLC _dDLC _erda |
||
| 050 | 0 | 0 |
_aQD75.4.Q34 _bS93 2012 |
| 082 | 0 | 0 |
_a543 _223 _bS.M.H |
| 100 | 1 |
_aSwartz, Michael _q(Michael E.) |
|
| 245 | 1 | 0 |
_aHandbook of analytical validation / _cMichael E. Swartz, Ira S. Krull. |
| 260 |
_aBoca Raton, FL : _bCRC Press, _cc2012. |
||
| 300 |
_axiv, 206 p. : _bill. ; _c25 cm. |
||
| 336 |
_2rdacontent _atext |
||
| 337 |
_2rdamedia _aunmediated |
||
| 338 |
_2rdacarrier _avolume |
||
| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | _a Front Cover; Contents; Preface; Chapter 1: Introduction to Analytical Method Validation; Chapter 2: Analytical Instrument Qualification; Chapter 3: HPLC Method Development and Optimization with Validation in Mind; Chapter 4: Method Validation Basics; Chapter 5: Robustness and System Suitability; Chapter 6: Setting Specifications and Investigating Out-of-Specification Results; Chapter 7: Validation by Type of Method; Chapter 8: Analytical Method Transfer; Chapter 9: Implementing New Technology in a Regulated Environment; Glossary of Terms Related to Chromatographic Method Validation | |
| 520 | _aWritten for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook: Contains practical, up-to-date guidelines for analytical method validation Summarizes the latest regulatory requirements for all aspects of method validation, even those coming from the USP, but undergoing modifications Covers development, optimization, validation, and transfer of many different types | ||
| 650 | 0 |
_aChemistry, Analytic _xQuality control _vHandbooks, manuals, etc. |
|
| 650 | 0 |
_aChemistry, Analytic _xMethodology _vHandbooks, manuals, etc. |
|
| 700 | 1 |
_aKrull, Ira S., _d1940- |
|
| 856 |
_3Abstract _uhttp://repository.fue.edu.eg/xmlui/handle/123456789/2745 |
||
| 942 |
_cBK _2ddc |
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