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Record Nr. |
UNINA9910141258903321 |
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Titolo |
Analytical techniques for clinical chemistry [[electronic resource] ] : methods and applications / / edited by Sergio Caroli, Gyula Záray |
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Pubbl/distr/stampa |
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ISBN |
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1-280-77257-3 |
9786613683342 |
1-118-27184-X |
1-118-27185-8 |
1-118-27183-1 |
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Descrizione fisica |
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1 online resource (840 p.) |
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Altri autori (Persone) |
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CaroliSergio <1943-> |
ZárayGyula |
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Disciplina |
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Soggetti |
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Clinical chemistry - Analysis |
Biochemistry |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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Nota di bibliografia |
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Includes bibliographical references at the end of each chapters and index. |
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Nota di contenuto |
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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. |
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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 |
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Sommario/riassunto |
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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 |
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