| 000 -LEADER |
|---|
| fixed length control field |
01706nam a2200229 a 4500 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| ISBN |
0471259535 (hardcover) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| ISBN |
9780471259534 (hardcover) |
| 082 ## - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
610.28 Chan 17282 1st 2004 Pharmacology |
| 100 ## - MAIN ENTRY--AUTHOR NAME |
|---|
| Personal name |
Chan, Chung Chow. |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Analytical Method Validation and Instrument Performance Verification |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
1st ed. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication |
USA: |
| Name of publisher |
Wiley-Interscience; |
| Year of publication |
2004. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Number of Pages |
320 p. ; |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
Validation 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 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical Term |
Pharmaceutical chemistry |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical Term |
Pharmaceutical technology |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical Term |
Pharmaceutical product development |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Lee, Y. C. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Lam, Herman. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Zhang, Xue-Ming. |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Books |
