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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.
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 Pathology 139
Jose A. Centeno, Todor I. Todorov, Gijsbert B. van der Voet, and Florabel G. Mullick
6.1. Introduction 140
6.2. Biological Markers 140
6.3. Methodology for Trace Metal Ion Analysis in Clinical, Forensic, and Chemical Pathology 141
6.4. Case Studies of Relevance to Research and Diagnosis on Clinical Chemistry, Forensic Toxicology, and Chemical Pathology 144
PART II Selected Applications 157
7. Elemental Speciation in Clinical Sciences 159
Douglas M. Templeton
7.1. Introduction 159
7.2. Selected Elements 167
7.3. Conclusions 172
8. The Role of Analytical Chemistry in the Safety of Drug Therapy 179
Sandor Gorog
8.1. Drug Quality and Analysis: Their Role in Drug Safety 180
8.2. Methodological Aspects 189
8.3. The Role of Analytical Chemistry in Drug Research, Development, and Production 200
8.4. Future Trends 227
9. Analytical Techniques and Quality Control of Pharmaceuticals 245
Fedele Manna, Francesca Rossi, and Rossella Fioravanti
9.1. Introduction 245
9.2. Sources of Impurities in Medicines 246
9.3. Validation of Analytical Methods 247
9.4. Analytical Approaches 250
9.5. Conclusions 253
10. Detection of Drugs in Biological Fluids for Antidoping Control 257
Sabina Strano Rossi and Marcello Chiarotti
10.1. Introduction 257
10.2. Doping Control and Analytical Requirements 258
10.3. Confirmation Techniques 262
10.4. Conclusions 264
11. The Applicability of Plasma-Based Techniques to Biological Monitoring 269
Ilse Steffan and Goran Vujicic
11.1. Introduction 269
11.2. ICP as a Spectrochemical Source 271
11.3. Element Analysis in Environmental and Biological Materials 276
11.4. Conclusions 292
12. Atomic Spectrometric Techniques for the Analysis of Clinical Samples 319
Pilar Bermejo Barrera, Antonio Moreda Pineiro, and Mar?a del Carmen Barciela Alonso
12.1. Introduction 320
12.2. Analytical Techniques 320
12.3. Sample Preparation 347
12.4. Speciation Analysis 351
12.5. Quality Control in Trace Element Determination 355
12.6. Conclusions 358
13. Applications of ICP-MS in Human Biomonitoring Studies 367
Peter Heitland and Helmut D. Koster
13.1. Introduction 367
13.2. Advantages and Limitations of Inductively Coupled Plasma Mass Spectrometry 368
13.3. Sample Collection and Storage 370
13.4. Sample Preparation 371
13.5. Human Biomonitoring by Inductively Coupled Plasma Mass Spectrometry 374
13.6. Trace Element Speciation and Metallomics 382
13.7. Determination of Stable Isotopes 384
13.8. Method Validation and Quality Assurance 384
13.9. Conclusions 387
14. Molybdenum in Biological Samples and Clinical Significance of Serum Molybdenum 397
Munehiro Yoshida
14.1. Introduction 397
14.2. Analysis of Molybdenum in Biological Samples by Inductively Coupled Plasma Mass Spectrometry 398
14.3. Molybdenum in Food 400
14.4. Molybdenum in Human Samples 401
14.5. Clinical Significance of Serum and Plasma Mo 404
14.6. Conclusions 406
15. Application of Organometallic Speciation in Clinical Studies 409
Bin He, Chungang Yuan, Jing Sun, and Guibin Jiang
15.1. Introduction 409
15.2. Arsenic 410
15.3. Mercury 422
15.4. Tin 432
15.5. Conclusions 441
16. Biosensors for Drug Analysis 455
Daniela Deriu and Franco Mazzei
16.1. Introduction 455
16.2. Basic Concepts 456
16.3. Electrochemical Biosensors 460
16.4. Surface Plasmon Resonance 462
16.5. Biosensors for Drugs Analysis 465
16.6. Conclusions 471
17. Bioimaging of Metals and Proteomic Studies of Clinical Samples by Laser Ablation Inductively Coupled Plasma Mass Spectrometry (LA-ICP-MS) 479
J. Sabine Becker and J. Susanne Becker
17.1. Introduction 480
17.2. Analytical Approaches 481
17.3. Experimental Aspects of Imaging Laser Ablation Inductively Coupled Plasma Mass Spectrometry 485
17.4. Conclusions 498
18. Applications of LC-MS/MS in Clinical Laboratory Diagnostics 507
Uta Ceglarek, Georg Martin Fiedler, and Joachim Thiery
18.1. Introduction 507
18.2. Current Applications and Future Perspectives 513
18.3. Liquid Chromatography-Tandem Mass Spectrometry Applications in Clinical Laboratories 520
18.4. Conclusions 528
19. Metabolomics Using UPLC/HPLC-Tandem Mass Spectrometry in Diagnosis and Research of Inherited Metabolic Diseases 535
Willem Kulik and Andre B. P. van Kuilenburg
19.1. Introduction 536
19.2. Acylcarnitines 537
19.3. Acyl-Coenzyme A Thioesters 538
19.4. Amino Acids 540
19.5. Organic Acids 542
19.6. Purines and Pyrimidines 542
19.7. Bile Acids 544
19.8. Lipidomics 545
19.9. Carbohydrates 548
19.10. Neurotransmitters 548
19.11. Conclusions 549
20. Biomarkers of Oxidative Stress in Plasma and Urine 555
Papasani V. Subbaiah
20.1. Introduction 556
20.2. Antioxidant Mechanisms and Assays 558
20.3. Concluding Remarks and Perspectives 583
21. The Use of X-Ray Techniques in Medical Research 595
Imre Szaloki, Gyula Zaray, and Norbert Szoboszlai
21.1. Introduction 595
21.2. Physical Basis of XRF Analytical Methods 596
21.3. Basic Equipment and Setup for X-Ray Fluorescence Analysis 597
21.4. Quantification Approaches 606
21.5. Sample Preparation Techniques 609
21.6. Applications 610
21.7. Conclusions 617
PART III Future Trends 625
22. A New Tool Based on the Use of Stable Isotopes and Isotope Pattern Deconvolution (IPD)-ICP-MS for Nutritional and Clinical Studies 627
Hector Gonzalez Iglesias, Maria Luisa Fernandez-Sanchez, and Alfredo Sanz-Medel
22.1. Introduction 627
22.2. Milk as Source of Trace Elements 628
22.3. Stable Isotopes and Trace Elements Metabolism 629
22.4. Isotope Pattern Deconvolution 631
22.5. Selenium Metabolism in Lactating Rats by Means of Stable Isotopes and Isotope Pattern Deconvolution 631
22.6. Determination of Selenium in Urine, Faeces, Serum, and Erythrocytes by Isotope Pattern Deconvolution Inductively Coupled Plasma Mass Spectrometry 634
22.7. Quantitative Speciation of Selenium in Urine, Serum, and Erythrocytes by High Performance Isotope Pattern Deconvolution Inductively Coupled Plasma Mass Spectrometry 637
22.8. An Application of Isotope Pattern Deconvolution to Clinical Studies 643
22.9. Conclusions 645
23. Breath Analysis: Analytical Methodologies and Clinical Applications 651
Alessio Ceccarini, Fabio Di Francesco, Roger Fuoco, Silvia Ghimenti, Massimo Onor, Sara Tabucchi, and Maria Giovanna Trivella
23.1. Introduction 652
23.2. Sampling Methods 655
23.3. Analytical Techniques 658
23.4. Application of Breath Analysis 664
23.5. Exposure Assessment 675
23.6. Exhaled Breath Condensate 677
23.7. Conclusions 677
24. Proteo-Metabolomic Strategies in the Future of Drug Development 691
Uwe Christians, Volker Schmitz, Jost Klawitter, and Jelena Klawitter
24.1. Introduction 692
24.2. The Principles of Molecular Marker Development 699
24.3. Technologies for Molecular Marker Development 718
24.4. Molecular Markers in Drug Development and Clinical Monitoring 737
24.5. Current Challenges 749
25. Basics in Laboratory Medicine: Past, Present, and Future 775
Lorand A. Debreczeni, Anna Kovacsay, and Sandor Nagy
25.1. Introduction 776
25.2. Informatics 777
25.3. Global Standardization 778
25.4. Focus on the Individual 782
25.5. A Look into the Future 783
References 784
INDEX 787
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