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Analytical techniques for clinical chemistry [[electronic resource] ] : methods and applications / / edited by Sergio Caroli, Gyula Záray
| Analytical techniques for clinical chemistry [[electronic resource] ] : methods and applications / / edited by Sergio Caroli, Gyula Záray |
| Pubbl/distr/stampa | Hoboken, : Wiley, c2012 |
| Descrizione fisica | 1 online resource (840 p.) |
| Disciplina | 616.07/9 |
| Altri autori (Persone) |
CaroliSergio <1943->
ZárayGyula |
| Soggetto topico |
Clinical chemistry - Analysis
Biochemistry |
| ISBN |
1-280-77257-3
9786613683342 1-118-27184-X 1-118-27185-8 1-118-27183-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNINA-9910141258903321 |
| Hoboken, : Wiley, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Analytical techniques for clinical chemistry : methods and applications / / edited by Sergio Caroli, Gyula Zaray
| Analytical techniques for clinical chemistry : methods and applications / / edited by Sergio Caroli, Gyula Zaray |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, : Wiley, c2012 |
| Descrizione fisica | 1 online resource (840 p.) |
| Disciplina | 616.07/9 |
| Altri autori (Persone) |
CaroliSergio <1943->
ZarayGyula |
| Soggetto topico |
Clinical chemistry - Analysis
Biochemistry |
| ISBN |
9786613683342
9781280772573 1280772573 9781118271841 111827184X 9781118271858 1118271858 9781118271834 1118271831 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| 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 |
| Record Nr. | UNINA-9910820480403321 |
| Hoboken, : Wiley, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
