05325nam 2200673Ia 450 991014125890332120230801223251.01-280-77257-397866136833421-118-27184-X1-118-27185-81-118-27183-1(CKB)2670000000205655(EBL)836588(OCoLC)798698959(SSID)ssj0000676661(PQKBManifestationID)11460148(PQKBTitleCode)TC0000676661(PQKBWorkID)10683191(PQKB)10199712(MiAaPQ)EBC836588(MiAaPQ)EBC4033600(Au-PeEL)EBL836588(CaPaEBR)ebr10570761(CaONFJC)MIL368334(EXLCZ)99267000000020565520111116d2012 uy 0engur|n|---|||||txtccrAnalytical techniques for clinical chemistry[electronic resource] methods and applications /edited by Sergio Caroli, Gyula ZárayHoboken Wileyc20121 online resource (840 p.)Includes index.0-470-44527-0 Includes bibliographical references at the end of each chapters and index.Analytical 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 Practice1.3. 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 Studies1.5.3. 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 CountriesReferences2. 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)3.2.6. 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 Intervals3.7. Estimating Preanalytical UncertaintyDiscover 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 ChemistryClinical chemistryAnalysisBiochemistryClinical chemistryAnalysis.Biochemistry.616.07/9Caroli Sergio1943-502045Záray Gyula871585MiAaPQMiAaPQMiAaPQBOOK9910141258903321Analytical techniques for clinical chemistry1945605UNINA