000 | 01424cam a22003618a 4500 | ||
---|---|---|---|
001 | 920222 | ||
003 | OCoLC | ||
005 | 20210921174747.0 | ||
008 | 030217s2003 flu 000 0 eng | ||
020 | _a1587160072 | ||
020 |
_a9781587160073 : _c£32.99 |
||
040 |
_aUKM _cUKM _dOCLCQ |
||
043 | _an-us--- | ||
082 | 0 | 4 |
_a615.190973 _bPIS |
100 | 1 |
_aPisano, Douglas J. _938605 |
|
245 | 1 | 0 |
_aFDA regulatory affairs : _ba guide for prescription drugs, medical devices and biologics / |
260 |
_aBoca Raton, Fla. ; _aLondon : _bCRC, _c2003. |
||
300 |
_a250 p. ; _c23 cm. |
||
336 |
_atext _2rdacontent |
||
337 |
_aunmediated _2rdamedia |
||
338 |
_avolume _2rdacarrier |
||
520 | 8 | _aThis text covers the regulatory requirements of pharmaceuticals, biologics, and medical devices. It examines the pertinent aspects of the Federal Food, Drug and Cosmetic Act as it applies to human drug and device development, research, manufacturing, and marketing. | |
610 | 1 | 0 |
_aUnited States. _bFood and Drug Administration _vRules and practice. |
650 | 0 |
_aDrugs _zUnited States _xTesting. |
|
650 | 0 |
_aDrug development _zUnited States. |
|
650 | 0 |
_aPharmaceutical industry _zUnited States. |
|
650 | 0 |
_aMedical instruments and apparatus _zUnited States. |
|
902 | _a161214 | ||
907 |
_a.b10436303 _bmulti _c- |
||
942 | _n0 | ||
948 | _hNO HOLDINGS IN LQI - 1 OTHER HOLDINGS | ||
998 |
_b0 _c050117 _dm _ea _g0 |
||
999 |
_c41592 _d41592 |