02045cam a22003494a 450000100090000000300040000900500170001300800410003001000170007102000360008803500200012404000230014404200080016705000220017506000220019708200150021924501160023426000480035030000320039850400510043050503680048150502820084950502230113165000460135465000540140065000430145465000480149765000400154565000470158565000410163270000220167313248195OSt20150408113723.0030619s2004 njua b 001 0 eng  a 2003014141 a0471259535 (cloth : alk. paper) a(DNLM)101182631 aDNLM/DLCcDLCdDLC apcc00aRS189b.A568 200410aQV 744bA532 200400a610.2822100aAnalytical method validation and instrument performance verification /cedited by Chung Chow Chan ... [et al.]. aHoboken, N.J. :bJohn Wiley & Sons,cc2004. ax, 303 p. :bill. ;c24 cm. aIncludes bibliographical references and index.0 aOverview 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 --0 aDevelopment 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 --0 aThe 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. 0aDrugsxAnalysisxMethodologyxEvaluation. 0aLaboratoriesxEquipment and suppliesxEvaluation. 0aLaboratoriesxInstrumentsxEvaluation.12aChemistry, Pharmaceuticalxinstrumentation.12aChemistry, Pharmaceuticalxmethods.22aClinical Laboratory Techniquesxstandards.22aTechnology, Pharmaceuticalxmethods.1 aChan, Chung Chow.