Caroli, S 　著

内容

目次

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 Marya 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