TY  - BOOK
AU  - Chan,Chung Chow
TI  - Analytical Method Validation and Instrument Performance Verification
SN  - 0471259535 (cloth : alk. paper)
U1  - 610.28/ A532 23
PY  - 2004///
CY  - Hoboken, N.J.
PB  - John Wiley & Sons
KW  - Drugs
KW  - Analysis
KW  - Methodology
KW  - Evaluation
KW  - Laboratories
KW  - Equipment and supplies
KW  - Instruments
KW  - Chemistry, Pharmaceutical
KW  - instrumentation
KW  - methods
KW  - Clinical Laboratory Techniques
KW  - standards
KW  - Technology, Pharmaceutical
N1  - Includes bibliographical references and index; Overview of pharmaceutical product development and its associated quality system / Chung Chow Chan and Eric Jensen -- Potency method validation / Chung Chow Chan -- Method validation for HPLC analysis of related substances in pharmaceutical drug products / YC Lee -- Dissolution method validation / Chung Chow Chan, Neil Pearson, Anna Rebelo-Cameirao, Y.C. Lee --; Development and validation of automated methods / Chantal Incledon and Herman Lam -- The analysis of pharmaceutical inactive ingredients / Xue-Ming Zhang -- Validation study of JP heavy metal limit test / Yoshiki Nishiyama -- Bioanalytical method validation / Fabio Garofolo --; The procurement, qualification and calibration of laboratory instruments: an overview / Herman Lam -- Performance verification of UV-VIS spectrophotometers / Herman Lam -- Performance verification of HPLC / Herman Lam; PH, MPH
ER  -