| 000 | 01706nam a2200229 a 4500 | ||
|---|---|---|---|
| 020 | _a0471259535 (hardcover) | ||
| 020 | _a9780471259534 (hardcover) | ||
| 082 | _a610.28 Chan 17282 1st 2004 Pharmacology | ||
| 100 |
_aChan, Chung Chow. _911175 |
||
| 245 | 1 | 0 | _aAnalytical Method Validation and Instrument Performance Verification |
| 250 | _a1st ed. | ||
| 260 |
_aUSA: _bWiley-Interscience; _c2004. |
||
| 300 | _a320 p. ; | ||
| 520 | _aValidation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories. | ||
| 650 |
_aPharmaceutical chemistry _911176 |
||
| 650 |
_aPharmaceutical technology _911138 |
||
| 650 |
_aPharmaceutical product development _911177 |
||
| 700 | 1 |
_aLee, Y. C. _911178 |
|
| 700 | 1 |
_aLam, Herman. _911179 |
|
| 700 | 1 |
_aZhang, Xue-Ming. _911180 |
|
| 942 | _cBK | ||
| 999 |
_c4517 _d4517 |
||