LEADER 01881nam 2200481I 450 001 9910705724203321 005 20170703105655.0 035 $a(CKB)5470000002453168 035 $a(OCoLC)992710816 035 $a(EXLCZ)995470000002453168 100 $a20170703j198502 ua 0 101 0 $aeng 135 $aur||||||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aSystem development and evaluation technology $estate of the art of manned system management /$fJoan M. Edwards, Richard F. Bloom, and Paul A. Brainin 210 1$aAlexandria, VA :$cU.S. Army Research Institute for the Behavioral and Social Science,$dFebruary 1985. 215 $a1 online resource (iv, 80 pages) $cillustrations 225 1 $aResearch note ;$v85-20 300 $a"February 1985." 300 $a"Performing organization: Dunlap and Associates East, Inc."--Report documentation page. 300 $a"293-8"--Report documentation page. 300 $a"Seward Smith, Contracting Officer's Representative"--Report documentation page. 320 $aIncludes bibliographical references (pages 60-80). 517 $aSystem development and evaluation technology 606 $aPerformance$xMeasurement 606 $aSystems engineering$zUnited States 606 $aHuman-machine systems$zUnited States 615 0$aPerformance$xMeasurement. 615 0$aSystems engineering 615 0$aHuman-machine systems 700 $aEdwards$b Joan M.$01419119 702 $aBloom$b Richard F. 702 $aBrainin$b Paul A. 712 02$aDunlap and Associates East, 712 02$aU.S. Army Research Institute for the Behavioral and Social Sciences, 801 0$bGPO 801 1$bGPO 906 $aBOOK 912 $a9910705724203321 996 $aSystem development and evaluation technology$93532661 997 $aUNINA LEADER 03100nam 22006134a 450 001 9911018975203321 005 20200520144314.0 010 $a9786610648986 010 $a9781280648984 010 $a1280648988 010 $a9780470042205 010 $a0470042206 010 $a9780470042199 010 $a0470042192 035 $a(CKB)1000000000355002 035 $a(EBL)273997 035 $a(OCoLC)476017670 035 $a(SSID)ssj0000266480 035 $a(PQKBManifestationID)11206713 035 $a(PQKBTitleCode)TC0000266480 035 $a(PQKBWorkID)10304824 035 $a(PQKB)11757582 035 $a(MiAaPQ)EBC273997 035 $a(Perlego)2788071 035 $a(EXLCZ)991000000000355002 100 $a20051220d2006 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aValidating chromatographic methods $ea practical guide /$fDavid M. Bliesner 210 $aHoboken, N.J. $cWiley$dc2006 215 $a1 online resource (301 p.) 300 $aDescription based upon print version of record. 311 08$a9780471741473 311 08$a0471741477 320 $aIncludes bibliographical references (p. 283) and index. 327 $aVALIDATING CHROMATOGRAPHIC METHODS; CONTENTS; PREFACE; 1. OVERVIEW OF METHODS VALIDATION; 2. COMPONENTS OF METHODS VALIDATION; 3. STEP 1: METHOD EVALUATION AND FURTHER DEVELOPMENT; 4. STEP 2: FINAL METHOD DEVELOPMENT AND TRIAL METHODS VALIDATION; 5. STEP 3: FORMAL METHODS VALIDATION AND REPORT GENERATION; 6. STEP 4: FORMAL DATA REVIEW AND REPORT ISSUANCE; 7. SUMMARY; APPENDICES; I. GLOSSARY OF METHODS VALIDATION TERMS; II. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION STANDARD OPERATING PROCEDURE (SOP); III. TEMPLATE FOR AN EXAMPLE END-USER REQUIREMENTS QUESTIONNAIRE 327 $aIV. TEMPLATE FOR AN EXAMPLE METHOD REVIEW CHECKLISTV. TEMPLATE FOR AN EXAMPLE STANDARD TEST METHOD; VI. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION PROTOCOL; VII. TEMPLATE FOR AN EXAMPLE METHODS VALIDATION REPORT; REFERENCES; INDEX 330 $aAll the information and tools needed to set up a successful method validation system Validating Chromatographic Methods brings order and Current Good Manufacturing Practices to the often chaotic process of chromatographic method validation. It provides readers with both the practical information and the tools necessary to successfully set up a new validation system or upgrade a current system to fully comply with government safety and quality regulations. The net results are validated and transferable analytical methods that will serve for extended periods of time with minimal 606 $aChromatographic analysis$xValidity 606 $aScience$xMethodology 615 0$aChromatographic analysis$xValidity. 615 0$aScience$xMethodology. 676 $a543/.8 700 $aBliesner$b David M$0890967 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9911018975203321 996 $aValidating chromatographic methods$94416881 997 $aUNINA