Analytical techniques for clinical chemistry : methods and applications / / edited by Sergio Caroli, Gyula Zaray

• Pubblicazione: Hoboken, : Wiley, c2012
• Edizione: 1st ed.
• Descrizione fisica: 1 online resource (840 p.)
• Disciplina: 616.07/9
• Soggetto topico: Clinical chemistry - Analysis; Biochemistry
• Altri autori: CaroliSergio <1943-> ZarayGyula
• Note generali: Includes index.
• Nota di bibliografia: Includes bibliographical references at the end of each chapters and index.
• Nota di contenuto: 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 Practice ; 1.3. 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 ; 1.5.3. 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 ; References2. 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 Intervals ; 3.7. Estimating Preanalytical Uncertainty
• Sommario/riassunto: Discover 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
• Titolo autorizzato: Analytical techniques for clinical chemistry
• ISBN: 9786613683342; 9781280772573; 1280772573; 9781118271841; 111827184X; 9781118271858; 1118271858; 9781118271834; 1118271831
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Lingua di pubblicazione: Inglese
• Record Nr.: 9910820480403321
• Lo trovi qui: Univ. Federico II