Bioanalysis of Pharmaceuticals

Bioanalysis of Pharmaceuticals

Author: Steen Honoré Hansen

Publisher: John Wiley & Sons

Published: 2015-07-20

Total Pages: 332

ISBN-13: 1118716825

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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 examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents 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 laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The 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.


Book Synopsis Bioanalysis of Pharmaceuticals by : Steen Honoré Hansen

Download or read book Bioanalysis of Pharmaceuticals written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents 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 laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The 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.

Bioanalysis of Pharmaceuticals

Bioanalysis of Pharmaceuticals

Author: Steen Honoré Hansen

Publisher: John Wiley & Sons

Published: 2015-07-20

Total Pages: 332

ISBN-13: 1118716817

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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 examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents 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 laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The 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.


Book Synopsis Bioanalysis of Pharmaceuticals by : Steen Honoré Hansen

Download or read book Bioanalysis of Pharmaceuticals written by Steen Honoré Hansen and published by John Wiley & Sons. This book was released on 2015-07-20 with total page 332 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents 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 laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The 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.

Bioanalysis of Pharmaceuticals

Bioanalysis of Pharmaceuticals

Author: Steen Honor? Hansen

Publisher: Wiley

Published: 2015-06-25

Total Pages: 336

ISBN-13: 9781118716878

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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 examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents 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 laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The 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.


Book Synopsis Bioanalysis of Pharmaceuticals by : Steen Honor? Hansen

Download or read book Bioanalysis of Pharmaceuticals written by Steen Honor? Hansen and published by Wiley. This book was released on 2015-06-25 with total page 336 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 examples Focuses on substances that are administered as human drugs, including low-molecular drug substances, peptides, and proteins Presents 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 laboratories Is aimed at undergraduate students, scientists, technicians and researchers in industry working in the areas of pharmaceutical analyses, biopharmaceutical analyses, biological and life sciences The 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.

Handbook of LC-MS Bioanalysis

Handbook of LC-MS Bioanalysis

Author: Wenkui Li

Publisher: John Wiley & Sons

Published: 2013-09-03

Total Pages: 709

ISBN-13: 111867135X

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Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.


Book Synopsis Handbook of LC-MS Bioanalysis by : Wenkui Li

Download or read book Handbook of LC-MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-09-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.

A Handbook of Bioanalysis and Drug Metabolism

A Handbook of Bioanalysis and Drug Metabolism

Author: Gary Evans

Publisher: CRC Press

Published: 2004-03-29

Total Pages: 412

ISBN-13: 9780203642535

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Recent years have seen a greater industrial emphasis in undergraduate and postgraduate courses in the pharmaceutical and chemical sciences. However, textbooks have been slow to adapt, leaving the field without a text/reference that is both instructional and practical in the industrial setting – until now. A Handbook of Bioanalysis and Drug Metabolismis a stimulating new text that examines the techniques, methodology, and theory of bioanalysis, pharmacokinetics, and metabolism from the perspective of scientists with extensive professional experience in drug discovery and development. These three areas of research help drug developers to optimize the active component within potential drugs thereby increasing their effectiveness, and to provide safety and efficacy information required by regulators when granting a drug license. Professionals with extensive experience in drug discovery and development as well as specialized knowledge of the individual topics contributed to each chapter to create a current and well-credentialed text. It covers topics such as high performance liquid chromatography, protein binding, pharmacokinetics and drug–drug interactions. The unique industrial perspective helps to reinforce theory and develop valuable analytical and interpreting skills. This text is an invaluable guide to students in courses such as pharmaceutical science, pharmacology, chemistry, physiology and toxicology, as well as professionals in the biotechnology industry.


Book Synopsis A Handbook of Bioanalysis and Drug Metabolism by : Gary Evans

Download or read book A Handbook of Bioanalysis and Drug Metabolism written by Gary Evans and published by CRC Press. This book was released on 2004-03-29 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent years have seen a greater industrial emphasis in undergraduate and postgraduate courses in the pharmaceutical and chemical sciences. However, textbooks have been slow to adapt, leaving the field without a text/reference that is both instructional and practical in the industrial setting – until now. A Handbook of Bioanalysis and Drug Metabolismis a stimulating new text that examines the techniques, methodology, and theory of bioanalysis, pharmacokinetics, and metabolism from the perspective of scientists with extensive professional experience in drug discovery and development. These three areas of research help drug developers to optimize the active component within potential drugs thereby increasing their effectiveness, and to provide safety and efficacy information required by regulators when granting a drug license. Professionals with extensive experience in drug discovery and development as well as specialized knowledge of the individual topics contributed to each chapter to create a current and well-credentialed text. It covers topics such as high performance liquid chromatography, protein binding, pharmacokinetics and drug–drug interactions. The unique industrial perspective helps to reinforce theory and develop valuable analytical and interpreting skills. This text is an invaluable guide to students in courses such as pharmaceutical science, pharmacology, chemistry, physiology and toxicology, as well as professionals in the biotechnology industry.

Principles and Practice of Bioanalysis

Principles and Practice of Bioanalysis

Author: Richard F. Venn

Publisher: CRC Press

Published: 2000-06-22

Total Pages: 392

ISBN-13: 9780748408429

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Principles and Practice of Bioanalysis provides a guide to the methods available and the techniques currently used in this field. It provides up to the minute information and guidance on the methods and strategy used in developing and running ultra-trace analyses for drugs, metabolites and other substances. The authors writes in an informal and didactic style, offering a logical path through the problems of small molecule (bio)analysis and enables readers to choose appropriate methods of analysis for their needs. Principles and Practice of Bioanalysis provides an overview of analytical methods for analytical scientists within the pharmaceutical industry, research and development, the agrochemical industry, and scientists in the health service, biology and biochemistry. It also gives postgraduate students a useful reference for their research methods.


Book Synopsis Principles and Practice of Bioanalysis by : Richard F. Venn

Download or read book Principles and Practice of Bioanalysis written by Richard F. Venn and published by CRC Press. This book was released on 2000-06-22 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: Principles and Practice of Bioanalysis provides a guide to the methods available and the techniques currently used in this field. It provides up to the minute information and guidance on the methods and strategy used in developing and running ultra-trace analyses for drugs, metabolites and other substances. The authors writes in an informal and didactic style, offering a logical path through the problems of small molecule (bio)analysis and enables readers to choose appropriate methods of analysis for their needs. Principles and Practice of Bioanalysis provides an overview of analytical methods for analytical scientists within the pharmaceutical industry, research and development, the agrochemical industry, and scientists in the health service, biology and biochemistry. It also gives postgraduate students a useful reference for their research methods.

LC-MS in Drug Bioanalysis

LC-MS in Drug Bioanalysis

Author: Q. Alan Xu

Publisher: Springer Science & Business Media

Published: 2012-07-15

Total Pages: 476

ISBN-13: 1461438284

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Clinical pharmacology plays an important role in today’s medicine. Due to the high sensitivity, selectivity, and affordability of a mass spectrometer (MS), the high performance liquid chromatography – mass spectrometry (LC-MS) analytical technique is widely used in the determination of drugs in human biological matrixes for clinical pharmacology. Specifically, LC-MS is used to analyze: anticancer drugs antidementia drugs antidepressant drugs antiepileptic drugs antifundal drug antimicrobial drugs antipsychotic drugs antiretroviral drugs anxiolytic/hypnotic drugs cardiac drugs drugs for addiction immunosuppressant drugs mood stabilizer drugs This book will primarily cover the various methods of validation for LC-MS techniques and applications used in modern clinical pharmacology.


Book Synopsis LC-MS in Drug Bioanalysis by : Q. Alan Xu

Download or read book LC-MS in Drug Bioanalysis written by Q. Alan Xu and published by Springer Science & Business Media. This book was released on 2012-07-15 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: Clinical pharmacology plays an important role in today’s medicine. Due to the high sensitivity, selectivity, and affordability of a mass spectrometer (MS), the high performance liquid chromatography – mass spectrometry (LC-MS) analytical technique is widely used in the determination of drugs in human biological matrixes for clinical pharmacology. Specifically, LC-MS is used to analyze: anticancer drugs antidementia drugs antidepressant drugs antiepileptic drugs antifundal drug antimicrobial drugs antipsychotic drugs antiretroviral drugs anxiolytic/hypnotic drugs cardiac drugs drugs for addiction immunosuppressant drugs mood stabilizer drugs This book will primarily cover the various methods of validation for LC-MS techniques and applications used in modern clinical pharmacology.

Regulated Bioanalysis: Fundamentals and Practice

Regulated Bioanalysis: Fundamentals and Practice

Author: Mario L. Rocci Jr.

Publisher: Springer

Published: 2017-04-24

Total Pages: 230

ISBN-13: 3319548026

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The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.


Book Synopsis Regulated Bioanalysis: Fundamentals and Practice by : Mario L. Rocci Jr.

Download or read book Regulated Bioanalysis: Fundamentals and Practice written by Mario L. Rocci Jr. and published by Springer. This book was released on 2017-04-24 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

Sample Preparation in LC-MS Bioanalysis

Sample Preparation in LC-MS Bioanalysis

Author: Wenkui Li

Publisher: John Wiley & Sons

Published: 2019-03-12

Total Pages: 384

ISBN-13: 111927429X

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Revised and Expanded Handbook Provides Comprehensive Introduction and Complete Instruction for Sample Preparation in Vital Category of Bioanalysis Following in the footsteps of the previously published Handbook of LC-MS Bioanalysis, this book is a thorough and timely guide to all important sample preparation techniques used for quantitative Liquid Chromatography–Mass Spectrometry (LC-MS) bioanalysis of small and large molecules. LC-MS bioanalysis is a key element of pharmaceutical research and development, post-approval therapeutic drug monitoring, and many other studies used in human healthcare. While advances are continually being made in key aspects of LC-MS bioanalysis such as sensitivity and throughput, the value of research/study mentioned above is still heavily dependent on the availability of high-quality data, for which sample preparation plays the critical role. Thus, this text provides researchers in industry, academia, and regulatory agencies with detailed sample preparation techniques and step-by-step protocols on proper extraction of various analyte(s) of interest from biological samples for LC-MS quantification, in accordance with current health authority regulations and industry best practices. The three sections of the book with a total of 26 chapters cover topics that include: Current basic sample preparation techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction, salting-out assisted liquid-liquid extraction, ultracentrifugation and ultrafiltration, microsampling, sample extraction via electromembranes) Sample preparation techniques for uncommon biological matrices (e.g., tissues, hair, skin, nails, bones, mononuclear cells, cerebrospinal fluid, aqueous humor) Crucial aspects of LC-MS bioanalytical method development (e.g., pre-analytical considerations, derivation strategies, stability, non-specific binding) in addition to sample preparation techniques for challenging molecules (e.g., lipids, peptides, proteins, oligonucleotides, antibody-drug conjugates) Sample Preparation in LC-MS Bioanalysis will prove a practical and highly valuable addition to the reference shelves of scientists and related professionals in a variety of fields, including pharmaceutical and biomedical research, mass spectrometry, and analytical chemistry, as well as practitioners in clinical pharmacology, toxicology, and therapeutic drug monitoring.


Book Synopsis Sample Preparation in LC-MS Bioanalysis by : Wenkui Li

Download or read book Sample Preparation in LC-MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2019-03-12 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: Revised and Expanded Handbook Provides Comprehensive Introduction and Complete Instruction for Sample Preparation in Vital Category of Bioanalysis Following in the footsteps of the previously published Handbook of LC-MS Bioanalysis, this book is a thorough and timely guide to all important sample preparation techniques used for quantitative Liquid Chromatography–Mass Spectrometry (LC-MS) bioanalysis of small and large molecules. LC-MS bioanalysis is a key element of pharmaceutical research and development, post-approval therapeutic drug monitoring, and many other studies used in human healthcare. While advances are continually being made in key aspects of LC-MS bioanalysis such as sensitivity and throughput, the value of research/study mentioned above is still heavily dependent on the availability of high-quality data, for which sample preparation plays the critical role. Thus, this text provides researchers in industry, academia, and regulatory agencies with detailed sample preparation techniques and step-by-step protocols on proper extraction of various analyte(s) of interest from biological samples for LC-MS quantification, in accordance with current health authority regulations and industry best practices. The three sections of the book with a total of 26 chapters cover topics that include: Current basic sample preparation techniques (e.g., protein precipitation, liquid-liquid extraction, solid-phase extraction, salting-out assisted liquid-liquid extraction, ultracentrifugation and ultrafiltration, microsampling, sample extraction via electromembranes) Sample preparation techniques for uncommon biological matrices (e.g., tissues, hair, skin, nails, bones, mononuclear cells, cerebrospinal fluid, aqueous humor) Crucial aspects of LC-MS bioanalytical method development (e.g., pre-analytical considerations, derivation strategies, stability, non-specific binding) in addition to sample preparation techniques for challenging molecules (e.g., lipids, peptides, proteins, oligonucleotides, antibody-drug conjugates) Sample Preparation in LC-MS Bioanalysis will prove a practical and highly valuable addition to the reference shelves of scientists and related professionals in a variety of fields, including pharmaceutical and biomedical research, mass spectrometry, and analytical chemistry, as well as practitioners in clinical pharmacology, toxicology, and therapeutic drug monitoring.

Bioanalytical Aspects in Biological Therapeutics

Bioanalytical Aspects in Biological Therapeutics

Author: Xiaohui (Sophia) Xu

Publisher: John Wiley & Sons

Published: 2022-08-23

Total Pages: 404

ISBN-13: 1119523214

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Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.


Book Synopsis Bioanalytical Aspects in Biological Therapeutics by : Xiaohui (Sophia) Xu

Download or read book Bioanalytical Aspects in Biological Therapeutics written by Xiaohui (Sophia) Xu and published by John Wiley & Sons. This book was released on 2022-08-23 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioanalytical Aspects in Biological Therapeutics Deepen your understanding of how critical data are generated from bioanalysis In Bioanalytical Aspects in Biological Therapeutics, a team of renowned chemists, immunologists, and biologists delivers a timely and practical exploration of the diverse scientific and technical literature on the bioanalytical investigation of current biotherapeutics under development. The book discusses the challenges and considerations for bioanalytical support, covering a wide range of central topics in the field, including overview and basic immunology for testing of biological therapeutics, pharmacokinetic aspects, clinical immunogenicity prediction and testing, biomarker testing, biotransformation assessment for biologics, statistical aspects of bioanalytical testing, regulatory expectations, and more. Drug development and analysis professionals will learn how critical data are generated from bioanalysis and how proven tools and methods are applied to the development of biologics. Alongside coverage of topics like PK, immunogenicity, neutralizing antibody assays, and the importance of quality control for reagents, readers will benefit from: A thorough overview of the development of biotherapeutics and the role played by bioanalytical tests, as well as basic immunology for bioanalytical testing of biological therapeutics Comprehensive explorations of platform and instrument considerations in bioanalytical testing, pharmacokinetics assays, and biomarker analysis using LC-MS, LBA, and other technologies Practical discussions of immunogenicity prediction, preclinical and clinical anti-drug antibody assays, and bioanalytical schemes for anti-drug neutralizing antibody assays In-depth examinations of critical reagents in bioanalysis Regulatory expectations for bioanalytical method development, validation, and sample testing Perfect for pharmaceutical scientists in industry, Bioanalytical Aspects in Biological Therapeutics will also earn a place in the libraries of pharmaceutical regulators and other professionals working in pharmaceutical companies, as well as graduate students studying bioanalytical assays for biological therapeutics.