| 000 | 01092nam a22002177a 4500 | ||
|---|---|---|---|
| 005 | 20240401162232.0 | ||
| 008 | 240321b ||||| |||| 00| 0 eng d | ||
| 020 | _a9781032501574 | ||
| 040 | _cAL | ||
| 041 | _aeng | ||
| 082 |
_223 _a543 _bSWAA |
||
| 100 |
_aMichael E Swartz _9156023 |
||
| 245 | _aAnalytical method development and validation | ||
| 260 |
_aBoca Raton _bCRC _c2023 |
||
| 300 |
_a92p. _bPB _c21.5x14cm. |
||
| 365 |
_2General _a7743 _b716.00 _d895.00 _e20% _f15-02-2024 |
||
| 520 | _aDescribes analytical methods development, optimization and validation, and provides examples of successful methods development and validation in high-performance liquid chromatography (HPLC) areas. The text presents an overview of Food and Drug Administration (FDA)/International Conference on Harmonization (ICH) regulatory guidelines, compliance with validation requirements for regulatory agencies, and methods validation criteria stipulated by the US Pharmacopia, FDA and ICH. | ||
| 650 |
_2Chemistry _aAnalytical chemistry _9156024 |
||
| 700 |
_aKrull, Ira S _9156025 |
||
| 942 |
_2ddc _cBK |
||
| 999 |
_c230597 _d230597 |
||