LEADER 05453nam 2200745Ia 450 001 9910820480403321 005 20200520144314.0 010 $a9786613683342 010 $a9781280772573 010 $a1280772573 010 $a9781118271841 010 $a111827184X 010 $a9781118271858 010 $a1118271858 010 $a9781118271834 010 $a1118271831 035 $a(CKB)2670000000205655 035 $a(EBL)836588 035 $a(SSID)ssj0000676661 035 $a(PQKBManifestationID)11460148 035 $a(PQKBTitleCode)TC0000676661 035 $a(PQKBWorkID)10683191 035 $a(PQKB)10199712 035 $a(Au-PeEL)EBL836588 035 $a(CaPaEBR)ebr10570761 035 $a(CaONFJC)MIL368334 035 $a(OCoLC)798698959 035 $a(MiAaPQ)EBC836588 035 $a(Perlego)1002443 035 $a(EXLCZ)992670000000205655 100 $a20111116d2012 uy 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 00$aAnalytical techniques for clinical chemistry $emethods and applications /$fedited by Sergio Caroli, Gyula Zaray 205 $a1st ed. 210 $aHoboken $cWiley$dc2012 215 $a1 online resource (840 p.) 300 $aIncludes index. 311 08$a9780470445273 311 08$a0470445270 320 $aIncludes bibliographical references at the end of each chapters and index. 327 $aAnalytical Techniques for Clinical Chemistry: Methods and Applications; CONTENTS; FOREWORD; PREFACE; CONTRIBUTORS; PART I: Exploring Fundamentals; 1. Good Clinical Practice Principles: Legal Background and Applicability; Summary; 1.1. Introduction; 1.2. Good Clinical Practice; 1.2.1. ICH E6: Guidelines for Good Clinical Practice; 1.2.2. WHO Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products; 1.2.3. WHO Handbook for Good Clinical Research Practice Guidance for Implementation; 1.2.4. WHO Good Clinical Laboratory Practice 327 $a1.3. Good Clinical Practice: Legal Background in the European Union1.4. Good Clinical Practice: Applicability in the European Union; 1.4.1. EU 2007 Conference on the Implementation and Applicability in the European Union of Legislation on Clinical Trials of Medical Products; 1.4.2. Directives 2001/20/EC, 2005/28/EC, and Good Clinical Practice in Case of Noncommercial Clinical Trials; 1.5. Good Clinical Practice and Bioequivalence Trials: GCP Inspections and Laboratories; 1.5.1. General Aspects; 1.5.2. EMA Guidelines on Bioequivalence Studies 327 $a1.5.3. EMA Reflection Paper for Applicants Who Want to Submit Bioequivalence Performed Outside the European Union1.5.4. Good Clinical Practice Bioequivalence Inspections; 1.5.5. Good Clinical Practice Clinical Laboratory Inspections; 1.5.6. Good Clinical Practice Inspections on Phase I Units; 1.6. Good Clinical Practice for Clinical Trials with Advanced Therapy Medicinal Product; 1.7. Good Clinical Practice and Clinical Trials in Developing Countries; 1.7.1. The Increase of Clinical Trials in Developing Countries; 1.7.2. European Union Legislation and Clinical Trials in Developing Countries 327 $aReferences2. Clinical Chemistry and the Quest for Quality; Summary; 2.1. Introduction; 2.2. Quality Today; 2.2.1. General Aspects; 2.2.2. Major Quality Systems and Their Scope; 2.3. Conclusions; References; 3. Uncertainty in Clinical Chemistry Measurements Including Preanalytical Variables; Summary; 3.1. Introduction; 3.2. Analytical Uncertainty in Laboratory Results; 3.2.1. General Aspects; 3.2.2. Control Materials; 3.2.3. Estimating Analytical Precision; 3.2.4. Within-Run Precision (Repeatability); 3.2.5. Total Analytical Precision (Reproducibility) 327 $a3.2.6. Estimating Precision Using Duplicates3.3. Trueness and Traceability; 3.3.1. Basic Concepts; 3.3.2. Reference Methods and Materials; 3.3.3. Estimating the Trueness; 3.3.4. Factorizing the Patients' Results; 3.3.5. Changing Reagent Lot; 3.3.6. Analytical Specificity; 3.3.7. Method Validation; 3.4. Proficiency Testing; 3.4.1. Background Information; 3.4.2. Choice of EQA Schemes; 3.4.3. Interpretation and Actions; 3.5. Biological Variations and Quality Goals; 3.6. Reference Intervals; 3.6.1. Establishing Reference Intervals; 3.6.2. Transferring Reference Intervals 327 $a3.7. Estimating Preanalytical Uncertainty 330 $aDiscover how analytical chemistry supports the latest clinical research This book details the role played by analytical chemistry in fostering clinical research. Readers will discover how a broad range of analytical techniques support all phases of clinical research, from early stages to the implementation of practical applications. Moreover, the contributing authors' careful step-by-step guidance enables readers to better understand standardized techniques and steer clear of everyday problems that can arise in the lab. Analytical Techniques for Clinical Chemistry 606 $aClinical chemistry$xAnalysis 606 $aBiochemistry 615 0$aClinical chemistry$xAnalysis. 615 0$aBiochemistry. 676 $a616.07/9 701 $aCaroli$b Sergio$f1943-$0502045 701 $aZaray$b Gyula$01596040 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910820480403321 996 $aAnalytical techniques for clinical chemistry$93917218 997 $aUNINA