| 000 | 02061cam a2200373 i 4500 | ||
|---|---|---|---|
| 999 |
_c12874 _d12874 |
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| 001 | 4034122 | ||
| 005 | 20210307103309.0 | ||
| 008 | 980826s1999 nyua b 001 0 eng | ||
| 010 | _a 98027750 | ||
| 020 | _a0824702182 (alk. paper) | ||
| 040 |
_aDLC _cDLC _dDLC _erda |
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| 043 | _an-us--- | ||
| 050 | 0 | 0 |
_aRM301.27 _b.P74 1999 |
| 082 | 0 | 0 |
_a615.19 _222 _bP. |
| 245 | 0 | 0 |
_aPreparing for FDA pre-approval inspections / _cedited by Martin D. Hynes, III. |
| 264 | 1 |
_aNew York : _bMarcel Dekker Inc., _c[1999] |
|
| 264 | 4 | _c©1999 | |
| 300 |
_aix, 284 pages : _billustrations ; _c24 cm |
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| 336 |
_2rdacontent _atext |
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| 337 |
_2rdamedia _aunmediated |
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| 338 |
_2rdacarrier _avolume |
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| 490 | 1 |
_aDrugs and the pharmaceutical sciences ; _vv. 93 |
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| 504 | _aIncludes bibliographical references and index. | ||
| 505 | 0 | _aIntroduction to the Food and Drug Administration Pre-New Drug Applications Approval Inspections o Developing a Strategic Approach to Preparing for a Successful Pre-NDA Approval Inspection o Food and Drug Administration International Pre-Approval Inspections o Stability Data and Pre-Approval Inspections o Consequences of Failing a Pre-Approval Inspection o Successful Management of a Pre-Approval Inspection o The Validation of Pharmaceutical Processes o Documentation Standards for Pre-Approval Inspections o Technology Transfer and Scale-up o Training of Personnel in the Pharmaceutical Industry o Compliance with Current Good Manufacturing Practices and Application Commitments | |
| 610 | 1 | 0 |
_aUnited States. _bFood and Drug Administration. |
| 650 | 0 |
_aDrugs _xResearch _xStandards _zUnited States. |
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| 700 | 1 |
_aHynes, Martin D. _eeditor. |
|
| 830 | 0 | _tDrugs and the pharmaceutical sciences | |
| 856 | 4 | 2 |
_3Publisher description _uhttp://www.loc.gov/catdir/enhancements/fy0647/98027750-d.html |
| 906 |
_a7 _bcbc _corignew _d1 _eocip _f19 _gy-gencatlg |
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| 942 |
_2ddc _cBK |
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