03465nam 22006614a 450 991081544640332120200520144314.01-280-36739-397866103673990-470-30755-20-471-46371-X0-471-46372-8(CKB)111087027116206(EBL)468676(OCoLC)54781938(SSID)ssj0000103056(PQKBManifestationID)11131327(PQKBTitleCode)TC0000103056(PQKBWorkID)10061464(PQKB)10802931(DNLM)101182631(MiAaPQ)EBC468676(Au-PeEL)EBL468676(CaPaEBR)ebr10113960(CaONFJC)MIL36739(EXLCZ)9911108702711620620030619d2004 uy 0engur|n|---|||||txtrdacontentcrdamediacrrdacarrierAnalytical method validation and instrument performance verification /edited by Chung Chow Chan ... [et al.]1st ed.Hoboken, N.J. John Wiley & Sonsc20041 online resource (315 pages) illustrationsDescription based upon print version of record.0-471-25953-5 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.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.DrugsAnalysisMethodologyEvaluationLaboratoriesEquipment and suppliesEvaluationLaboratoriesInstrumentsEvaluationDrugsAnalysisMethodologyEvaluation.LaboratoriesEquipment and suppliesEvaluation.LaboratoriesInstrumentsEvaluation.610/.28Chan Chung Chow1608813MiAaPQMiAaPQMiAaPQBOOK9910815446403321Analytical method validation and instrument performance verification3935754UNINA