Bioanalysis of Pharmaceuticals

Sample Preparation, Separation Techniques and Mass Spectrometry

Häftad, Engelska, 2015

AvSteen Honore Hansen,Steen Honoré Hansen,Stig Pedersen-Bjergaard

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Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry is the first student textbook on the separation science and mass spectrometry of pharmaceuticals present in biological fluids with an educational presentation of the principles, concepts and applications. It discusses the chemical structures and properties of low- and high-molecular drug substances; the different types of biological samples and fluids that are used; how to prepare the samples by extraction, and how to perform the appropriate analytical measurements by chromatographic and mass spectrometric methods.Bioanalysis of Pharmaceuticals: Sample Preparation, Separation Techniques and Mass Spectrometry: Is an introductory student textbook discussing the different principles and concepts clearly and comprehensively, with many relevant and educational examplesFocuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteinsPresents both the basic principles that are regularly taught in universities, along with the practical use of bioanalysis as carried out by researchers in the pharmaceutical industry and in hospital laboratoriesIs aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciencesThe book includes multiple examples to illustrate the theory and application, with many practical aspects including calculations, thus helping the student to learn how to convert the data recorded by instruments into the real concentration of the drug substances within the biological sample.

Produktinformation

Utgivningsdatum2015-07-17
Mått244 x 244 x 18 mm
Vikt522 g
FormatHäftad
SpråkEngelska
Antal sidor336
FörlagJohn Wiley & Sons Inc
ISBN9781118716823

Tillhör följande kategorier

Biokemi inom Naturvetenskap och teknik
Farmakologi inom Medicin

Contributing Authors ix Preface xi1. Introduction 1Stig Pedersen-Bjergaard1.1 What Is Bioanalysis? 11.2 What Is the Purpose of Bioanalysis, and Where Is It Conducted? 21.3 Bioanalysis Is Challenging 61.4 The Different Sections of This Textbook 72. Physicochemical Properties of Drug Substances 9Steen Honoré Hansen and Leon Reubsaet2.1 Bioanalysis in General 92.2 Protolytic Properties of Analytes 102.3 Partitioning of Substances 122.4 Stereochemistry 152.5 Peptides and Proteins 183. Biological Samples: Their Composition and Properties, and Their Collection and Storage 23Steen Honoré Hansen3.1 Introduction 233.2 Blood, or Whole Blood 243.3 Plasma and Serum 263.4 Urine 263.5 Feces 273.6 Saliva 283.7 Cerebrospinal Fluid 283.8 Synovial Fluid 283.9 Hair and Nails 293.10 Tissue (Biopsies) 294. General Chromatographic Theory and Principles 31Steen Honoré Hansen4.1 General Introduction 314.2 General Chromatographic Theory 324.3 Theory of Partition 334.4 Retention 344.5 Separation Efficiency 354.6 Resolution 364.7 Selectivity 374.8 The Separation Process 384.9 Chromatographic Principles 414.10 Reversed Phase Chromatography 454.11 Size Exclusion Chromatography (SEC) 544.12 Ion Exchange Chromatography 564.13 Chiral Separations 575. Quantitative and Qualitative Chromatographic Analysis 61Steen Honoré Hansen5.1 Collection of Chromatographic Data 615.2 Quantitative Measurements 625.3 Calibration Methods 635.4 Validation 675.5 Qualitative Analysis 696. Sample Preparation 73Stig Pedersen-Bjergaard, Astrid Gjelstad, and Trine Grønhaug Halvorsen6.1 Why Is Sample Preparation Required? 736.2 What Are the Main Strategies? 756.3 Protein Precipitation 756.4 Liquid–Liquid Extraction 806.5 Solid-Phase Extraction 946.6 Dilute and Shoot 1106.7 What Are the Alternative Strategies? 1137. High-Performance Liquid Chromatography (HPLC) and High-Performance Liquid Chromatography–Mass Spectrometry (LC-MS) 123Steen Honoré Hansen and Leon Reubsaet7.1 Introduction 1237.2 The Solvent Delivery System 1257.3 Degassing and Filtering of Mobile Phases 1277.4 Injection of Samples 1287.5 Temperature Control 1287.6 Mobile Phases 1297.7 Stationary Phases and Columns 1307.8 Detectors 1357.9 Mass Spectrometric Detection 1438. Gas Chromatography (GC) 173Stig Pedersen-Bjergaard8.1 Basic Principles of GC 1738.2 GC Instrumentation 1748.3 Carrier Gas 1778.4 Stationary Phases 1788.5 Separation Selectivity in GC 1808.6 Columns 1828.7 Injection Systems 1838.8 Detectors 1858.9 Derivatization 1878.10 Gas Chromatography–Mass Spectrometry (GC-MS) 1889. Analysis of Small-Molecule Drugs in Biological Fluids 207Steen Honoré Hansen and Stig Pedersen-Bjergaard9.1 Plasma and Serum Samples 2079.2 Whole Blood Samples 2349.3 Dried Blood Spots 2419.4 Urine Samples 2459.5 Saliva 253References 25910. Analysis of Peptide and Protein Drugs in Biological Fluids 261Leon Reubsaet and Trine Grønhaug HalvorsenReferences 28211. Regulated Bioanalysis and Guidelines 283Martin Jørgensen and Morten A. Kall11.1 Introduction 28311.2 The Evolution of Regulated Bioanalysis 28411.3 Bioanalytical Method Validation 28611.4 Pre-study Validation 28711.5 In-Study Validation 29911.6 Documentation 30011.7 Regulatory Requirements to Bioanalysis 30011.8 Quality Systems in Regulated Bioanalysis 301Index 305