Analytical Techniques for Clinical Chemistry

FOREWORD xxiii
 
PREFACE xxv
 
CONTRIBUTORS xxvii
 
PART I Exploring Fundamentals 1
 
1. Good Clinical Practice Principles: Legal Background and Applicability 3
Umberto Filibeck, Angela Del Vecchio, and Fabrizio Galliccia
1.1. Introduction 4
1.2. Good Clinical Practice 4
1.3. Good Clinical Practice: Legal Background in the European Union 8
1.4. Good Clinical Practice: Applicability in the European Union 10
1.5. Good Clinical Practice and Bioequivalence Trials: GCP Inspections and Laboratories 13
1.6. Good Clinical Practice for Clinical Trials with Advanced Therapy Medicinal Product 20
1.7. Good Clinical Practice and Clinical Trials in Developing Countries 22
 
2. Clinical Chemistry and the Quest for Quality 29
Sergio Caroli
2.1. Introduction 30
2.2. Quality Today 31
2.3. Conclusions 55
 
3. Uncertainty in Clinical Chemistry Measurements Including Preanalytical Variables 59
Marit Sverresdotter Sylte, Tore Wentzel-Larsen, and Bjørn J. Bolann
3.1. Introduction 60
3.2. Analytical Uncertainty in Laboratory Results 62
3.3. Trueness and Traceability 67
3.4. Proficiency Testing 74
3.5. Biological Variations and Quality Goals 77
3.6. Reference Intervals 80
3.7. Estimating Preanalytical Uncertainty 83
3.8. Conclusions 92
 
4. The Role and Significance of Reference Values in the Identification and Evaluation of Trace Elements from Diet 97
Pietro Apostoli and Maria Cristina Ricossa
4.1. Reference Values 97
4.2. Reference Values in Specific Groups of Population: The Children Case 100
4.3. Trace Elements and Diet 106
4.4. Arsenic 108
4.5. Mercury 110
4.6. Lead 112
4.7. Chromium 114
4.8. Cadmium 115
4.9. Conclusions 116
 
5. Sample Collection, Storage, and Pretreatment in Clinical Chemistry 127
Andrew Taylor
5.1. Introduction 128
5.2. Collection Procedures 129
5.3. Storage 132
5.4. Pretreatment 133
5.5. Conclusions 136
 
6. Metal Toxicology in Clinical, Forensic, and Chemical

SERGIO CAROLI, PhD, was a research director in the Department of Food and Animal Safety, National Institute of Health in Rome, and Honorary Professor at Eötvös Loránd University. He is the author of approximately 400 papers and editor or coauthor of six books, including The Determination of Chemical Elements in Food: Applications for Atomic and Mass Spectrometry (Wiley).
 
GYULA ZÁRAY, PhD, DSc, is a Professor of Analytical Chemistry and the Director of the Cooperative Research Centre for Environmental Sciences at Eötvös Loránd University in Budapest. He has written more than 180 peer-reviewed publications and is the editor or coauthor of three books.

"The book is certainly worth buying for a laboratory or institution library, and individual chapters might be a useful background reading for specific topics that are covered in an analytical or clinical university course." ("Accreditation and Quality Assurance", 1 October 2013)

"This book is unique in its composition, as it focuses mainly on the analysis of heavy metals and trace elements but also includes some chapters that describe different aspects of the analysis of biological fluids and some other chapters on the analysis of pharmaceutical products. Based on the title of the book, it can be compared with other books that describe analytical techniques in clinical chemistry or clinical biochemistry." ( Anal Bioanal Chem , 29 December 2013)

"The book is certainly worth buying for a laboratory or institution library, and individual chapters might be a useful background reading for specific topics that are covered in an analytical or clinical university course." ( Accreditation and Quality Assurance , 1 October 2013)