An Introduction To Bioanalysis Of Biopharmaceuticals

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An Introduction to Bioanalysis of Biopharmaceuticals

Author : Seema Kumar
Publisher : Springer Nature
ISBN 13 : 3030971937
Total Pages : 166 pages
Book Rating : 4.0/5 (39 download)

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Book Synopsis An Introduction to Bioanalysis of Biopharmaceuticals by : Seema Kumar

Download or read book An Introduction to Bioanalysis of Biopharmaceuticals written by Seema Kumar and published by Springer Nature. This book was released on 2022-08-23 with total page 166 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides. The book starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.

Biotechnology and Biopharmaceuticals

Author :
Publisher : John Wiley & Sons
ISBN 13 : 111817979X
Total Pages : 744 pages
Book Rating : 4.1/5 (181 download)

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Book Synopsis Biotechnology and Biopharmaceuticals by :

Download or read book Biotechnology and Biopharmaceuticals written by and published by John Wiley & Sons. This book was released on 2013-12-16 with total page 744 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Bioanalysis of Pharmaceuticals

Author : Steen Honoré Hansen
Publisher : John Wiley & Sons
ISBN 13 : 1118716825
Total Pages : 332 pages
Book Rating : 4.1/5 (187 download)

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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.

Introduction to Pharmaceutical Analytical Chemistry

Author : Stig Pedersen-Bjergaard
Publisher : John Wiley & Sons
ISBN 13 : 111936275X
Total Pages : 752 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Introduction to Pharmaceutical Analytical Chemistry by : Stig Pedersen-Bjergaard

Download or read book Introduction to Pharmaceutical Analytical Chemistry written by Stig Pedersen-Bjergaard and published by John Wiley & Sons. This book was released on 2019-02-11 with total page 752 pages. Available in PDF, EPUB and Kindle. Book excerpt: The definitive textbook on the chemical analysis of pharmaceutical drugs – fully revised and updated Introduction to Pharmaceutical Analytical Chemistry enables students to gain fundamental knowledge of the vital concepts, techniques and applications of the chemical analysis of pharmaceutical ingredients, final pharmaceutical products and drug substances in biological fluids. A unique emphasis on pharmaceutical laboratory practices, such as sample preparation and separation techniques, provides an efficient and practical educational framework for undergraduate studies in areas such as pharmaceutical sciences, analytical chemistry and forensic analysis. Suitable for foundational courses, this essential undergraduate text introduces the common analytical methods used in quantitative and qualitative chemical analysis of pharmaceuticals. This extensively revised second edition includes a new chapter on chemical analysis of biopharmaceuticals, which includes discussions on identification, purity testing and assay of peptide and protein-based formulations. Also new to this edition are improved colour illustrations and tables, a streamlined chapter structure and text revised for increased clarity and comprehension. Introduces the fundamental concepts of pharmaceutical analytical chemistry and statistics Presents a systematic investigation of pharmaceutical applications absent from other textbooks on the subject Examines various analytical techniques commonly used in pharmaceutical laboratories Provides practice problems, up-to-date practical examples and detailed illustrations Includes updated content aligned with the current European and United States Pharmacopeia regulations and guidelines Covering the analytical techniques and concepts necessary for pharmaceutical analytical chemistry, Introduction to Pharmaceutical Analytical Chemistry is ideally suited for students of chemical and pharmaceutical sciences as well as analytical chemists transitioning into the field of pharmaceutical analytical chemistry.

Biopharmaceuticals

Author : Ming-Kung Yeh
Publisher : BoD – Books on Demand
ISBN 13 : 1789237181
Total Pages : 140 pages
Book Rating : 4.7/5 (892 download)

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Book Synopsis Biopharmaceuticals by : Ming-Kung Yeh

Download or read book Biopharmaceuticals written by Ming-Kung Yeh and published by BoD – Books on Demand. This book was released on 2018-09-19 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals are derived from biological sources, either live organisms or their active components; nowadays, they are mainly produced by biotechnologies. Biopharmaceuticals are extensively used in the treatment of various diseases such as cardiovascular, metabolic, neurological diseases, cancer, and others for which there are no available therapeutic methods. With the advance of science, biopharmaceuticals have revolutionized the treatment, prevention, and diagnosis of many patients with disabling and life-threatening diseases. Innovative biopharmaceuticals definitely improve the life quality of patients and enhance the effectiveness of the healthcare system. This book encompasses the discovery, production, application, and regulation of biopharmaceuticals to demonstrate their research achievement, prospects, and challenges. We expect the significance of biopharmaceuticals to be revealed and emphasized by this book.

Introduction to Pharmaceutical Analytical Chemistry

Author : Stig Pedersen-Bjergaard
Publisher : John Wiley & Sons
ISBN 13 : 1119362725
Total Pages : 546 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Introduction to Pharmaceutical Analytical Chemistry by : Stig Pedersen-Bjergaard

Download or read book Introduction to Pharmaceutical Analytical Chemistry written by Stig Pedersen-Bjergaard and published by John Wiley & Sons. This book was released on 2019-04-29 with total page 546 pages. Available in PDF, EPUB and Kindle. Book excerpt: Die umfassend überarbeitete 2. Auflage enthält ein neues Kapitel zur chemischen Analyse von Biopharmazeutika, in dem die Identifizierung, Reinheitsprüfung und die Analyse on Peptiden und proteinbasierten Formulierungen erläutert werden. Die neue Auflage bietet ebenfalls verbesserte farbige Abbildungen und Tabellen, eine gestraffte Kapitelstruktur und überarbeitete Inhalte, die das Fachgebiet klarer und verständlicher präsentieren. - Bietet eine Einführung in die grundlegenden Konzepte der pharmazeutischen analytischen Chemie und Statistik. - Untersucht systematisch pharmazeutische Anwendungen, die in anderen Lehrbüchern zu dem Fachgebiet fehlen. - Untersucht verschiedene Analysetechniken, die in der Regel in Pharmalaboren zur Anwendung kommen. - Präsentiert Fragestellungen aus der Praxis, aktuelle praktische Beispiele und detaillierte Illustrationen. - Die aktualisierten Inhalte entsprechen den aktuellen europäischen und US-amerikanischen Arzneibuchvorschriften und -richtlinien.

Sample Preparation in LC-MS Bioanalysis

Author : Wenkui Li
Publisher : John Wiley & Sons
ISBN 13 : 111927429X
Total Pages : 384 pages
Book Rating : 4.1/5 (192 download)

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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.

Introduction to Biopharmaceutics

Author : Milo Gibaldi
Publisher :
ISBN 13 :
Total Pages : 92 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Introduction to Biopharmaceutics by : Milo Gibaldi

Download or read book Introduction to Biopharmaceutics written by Milo Gibaldi and published by . This book was released on 1971 with total page 92 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Capillary Gel Electrophoresis

Author : Andras Guttman
Publisher : Newnes
ISBN 13 : 0080931359
Total Pages : 391 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Capillary Gel Electrophoresis by : Andras Guttman

Download or read book Capillary Gel Electrophoresis written by Andras Guttman and published by Newnes. This book was released on 2021-12-04 with total page 391 pages. Available in PDF, EPUB and Kindle. Book excerpt: Capillary Gel Electrophoresis and Related Microseparation Techniques covers all theoretical and practical aspects of capillary gel electrophoresis. It also provides an excellent overview of the key application areas of nucleic acid, protein and complex carbohydrate analysis, affinity-based methodologies, micropreparative aspects and related microseparation methods. It not only gives readers a better understanding of how to utilize this technology, but also provides insights into how to determine which method will provide the best technical solutions to particular problems. This book can also serve as a textbook for undergraduate and graduate courses in analytical chemistry, analytical biochemistry, molecular biology and biotechnology courses. - Covers all theoretical and practical aspects of capillary gel electrophoresis - Excellent overview of the key applications of nucleic acid, protein and complex carbohydrate analysis, affinity-based methodologies, micropreparative aspects and related microseparation methods - Teaches readers how to use the technology and select methods that are ideal for fundamental problems - Can serve as a textbook for undergraduate and graduate courses in analytical chemistry, analytical biochemistry, molecular biology and biotechnology courses

Flow Cytometry

Author : Alice Longobardi Givan
Publisher : John Wiley & Sons
ISBN 13 : 1118688392
Total Pages : 309 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Flow Cytometry by : Alice Longobardi Givan

Download or read book Flow Cytometry written by Alice Longobardi Givan and published by John Wiley & Sons. This book was released on 2013-04-10 with total page 309 pages. Available in PDF, EPUB and Kindle. Book excerpt: Flow cytometry continually amazes scientists with its ever-expanding utility. Advances in flow cytometry have opened new directions in theoretical science, clinical diagnosis, and medical practice. The new edition of Flow Cytometry: First Principles provides a thorough update of this now classic text, reflecting innovations in the field while outlining the fundamental elements of instrumentation, sample preparation, and data analysis. Flow Cytometry: First Principles, Second Edition explains the basic principles of flow cytometry, surveying its primary scientific and clinical applications and highlighting state-of-the-art techniques at the frontiers of research. This edition contains extensive revisions of all chapters, including new discussions on fluorochrome and laser options for multicolor analysis, an additionalsection on apoptosis in the chapter on DNA, and new chapters onintracellular protein staining and cell sorting, including high-speed sorting and alternative sorting methods, as well as traditional technology. This essential resource: Assumes no prior knowledge of flow cytometry Progresses with an informal, engaging lecture style from simpleto more complex concepts Offers a clear introduction to new vocabulary, principles of instrumentation, and strategies for data analysis Emphasizes the theory relevant to all flow cytometry, with examples from a variety of clinical and scientific fields Flow Cytometry: First Principles, Second Edition provides scientists, clinicians, technologists, and students with the knowledge necessary for beginning the practice of flow cytometry and for understanding related literature.

Immunogenicity of Biopharmaceuticals

Author : Marco Weert
Publisher : Springer
ISBN 13 : 9780387758404
Total Pages : 266 pages
Book Rating : 4.7/5 (584 download)

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Book Synopsis Immunogenicity of Biopharmaceuticals by : Marco Weert

Download or read book Immunogenicity of Biopharmaceuticals written by Marco Weert and published by Springer. This book was released on 2008-03-21 with total page 266 pages. Available in PDF, EPUB and Kindle. Book excerpt: Immunogenicity of Biopharmaceuticals is the first book to comprehensively address the potential of an immune response to biopharmaceuticals. It is intended to give a broad overview of the current state-of-the-art regarding this subject. The chapters range from an overview of the immune system and factors that may trigger the immune system, via detection of antibodies and clinical implications, to various case examples and the regulatory view on immunogenicity.

Biopharmaceuticals

Author : Gary Walsh
Publisher : John Wiley & Sons
ISBN 13 : 1118687388
Total Pages : 544 pages
Book Rating : 4.1/5 (186 download)

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Book Synopsis Biopharmaceuticals by : Gary Walsh

Download or read book Biopharmaceuticals written by Gary Walsh and published by John Wiley & Sons. This book was released on 2013-04-29 with total page 544 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Bioanalysis of Pharmaceuticals

Author : Steen Honoré Hansen
Publisher : John Wiley & Sons
ISBN 13 : 1118716841
Total Pages : 336 pages
Book Rating : 4.1/5 (187 download)

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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 2015-10-08 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.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author : Damian J. Houde
Publisher : Elsevier
ISBN 13 : 0444641742
Total Pages : 588 pages
Book Rating : 4.4/5 (446 download)

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Book Synopsis Biophysical Characterization of Proteins in Developing Biopharmaceuticals by : Damian J. Houde

Download or read book Biophysical Characterization of Proteins in Developing Biopharmaceuticals written by Damian J. Houde and published by Elsevier. This book was released on 2019-11-13 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Ion Mobility-Mass Spectrometry

Author : Alison E Ashcroft
Publisher : Royal Society of Chemistry
ISBN 13 : 1839162899
Total Pages : 621 pages
Book Rating : 4.8/5 (391 download)

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Book Synopsis Ion Mobility-Mass Spectrometry by : Alison E Ashcroft

Download or read book Ion Mobility-Mass Spectrometry written by Alison E Ashcroft and published by Royal Society of Chemistry. This book was released on 2021-11-11 with total page 621 pages. Available in PDF, EPUB and Kindle. Book excerpt: Over the last decade, the use of ion mobility separation in combination with mass spectrometry analysis has developed significantly. This technique adds a unique extra dimension enabling the in-depth analysis of a wide range of complex samples in the areas of the chemical and biological sciences. Providing a comprehensive guide to the technique, each chapter is written by an internationally recognised expert and with numerous different commercial platforms to choose from, this book will help the end users understand the practicalities of using different instruments for different ion mobility purposes. The first section provides a detailed account of the fundamentals behind the technique and the current range of available instrumentation. The second section focusses on the wide range of applications that have benefitted from ion mobility – mass spectrometry and includes topics taken from current research in the pharmaceutical, metabolomics, glycomics, and structural molecular biology fields. The book is primarily aimed at researchers, appealing to practising chemists and biochemists, as well as those in the pharmaceutical and medical fields.

Drug Metabolism, Pharmacokinetics and Bioanalysis

Author : Hye Suk Lee
Publisher : MDPI
ISBN 13 : 3038979163
Total Pages : 230 pages
Book Rating : 4.0/5 (389 download)

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Book Synopsis Drug Metabolism, Pharmacokinetics and Bioanalysis by : Hye Suk Lee

Download or read book Drug Metabolism, Pharmacokinetics and Bioanalysis written by Hye Suk Lee and published by MDPI. This book was released on 2019-06-12 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug metabolism/pharmacokinetics and drug interaction studies have been extensively carried out in order to secure the druggability and safety of new chemical entities throughout the development of new drugs. Recently, drug metabolism and transport by phase II drug metabolizing enzymes and drug transporters, respectively, as well as phase I drug metabolizing enzymes, have been studied. A combination of biochemical advances in the function and regulation of drug metabolizing enzymes and automated analytical technologies are revolutionizing drug metabolism research. There are also potential drug–drug interactions with co-administered drugs due to inhibition and/or induction of drug metabolic enzymes and drug transporters. In addition, drug interaction studies have been actively performed to develop substrate cocktails that do not interfere with each other and a simultaneous analytical method of substrate drugs and their metabolites using a tandem mass spectrometer. This Special Issue has the aim of highlighting current progress in drug metabolism/pharmacokinetics, drug interactions, and bioanalysis.

Mass Spectrometry in Drug Metabolism and Pharmacokinetics

Author : Ragu Ramanathan
Publisher : John Wiley & Sons
ISBN 13 : 111821157X
Total Pages : 326 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Mass Spectrometry in Drug Metabolism and Pharmacokinetics by : Ragu Ramanathan

Download or read book Mass Spectrometry in Drug Metabolism and Pharmacokinetics written by Ragu Ramanathan and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 326 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely reference discusses mass spectrometry in drug metabolism and pharmacokinetic studies. With contributions by professionals from the pharmaceutical industry, this book begins with a review of current mass spectrometry techniques and applications, followed by discussions of various methods for using MS in drug metabolism studies and pharmacokinetics. Highlighting the critical importance of ADME studies for understanding how a drug is absorbed, distributed, metabolized, and excreted by the body, the book s focuses on the use of LC/MS and MALDI-MS. This is a valuable reference for scientists in the pharmaceutical industry, medicine, academia, and even those working in homeland defense.