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High Throughput Bioanalytical Sample Preparation

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High Throughput Bioanalytical Sample Preparation

High Throughput Bioanalytical Sample Preparation Book
Author : David A. Wells
Publisher : Elsevier Science Limited
Release : 2003-01-28
ISBN : 0987650XXX
Language : En, Es, Fr & De

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Book Description :

High Throughput Bioanalytical Sample Preparation: Methods and Automation Strategies is an authoritative reference on the current state-of-the-art in sample preparation techniques for bioanalysis. This book focuses on high throughput (rapid productivity) techniques and describes exactly how to perform and automate these methodologies, including useful strategies for method development and optimization. A thorough review of the literature is included within each of these chapters describing high throughput sample preparation techniques: protein removal by precipitation; equilibrium dialysis and ultrafiltration; liquid-liquid extraction; solid-phase extraction; and various on-line techniques. The text begins with an introductory overview of the role of bioanalysis in pharmaceutical drug development. Fundamental understanding of the strategies for sample preparation is reinforced next, along with essential concepts in extraction chemistry. Several chapters introduce and discuss microplates, accessory products and automation devices. Particular strategies for efficient use of automation within a bioanalytical laboratory are also presented. The subject material then reviews protein precipitation, liquid-liquid extraction, solid-phase extraction and various on-line sample preparation approaches. The book concludes with information on recent advances in sample preparation, such as solid-phase extraction in a card format and higher density extraction plates. Important objectives that can be accomplished when the strategies presented in this book are followed include: improved efficiency in moving discovery compounds to preclinical status with robust analytical methods; return on investment in automation for sample preparation; and improved knowledge and expertise of laboratory staff. · Shows the reader exactly how to perform modern bioanalytical sample preparation techniques, complete with detailed strategies · Thorough literature review and summary of published information · Detailed discussion and examples of the method development process

Applied Biological Engineering

Applied Biological Engineering Book
Author : Ganesh R. Naik
Publisher : BoD – Books on Demand
Release : 2012-03-23
ISBN : 9535104128
Language : En, Es, Fr & De

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Book Description :

Biological engineering is a field of engineering in which the emphasis is on life and life-sustaining systems. Biological engineering is an emerging discipline that encompasses engineering theory and practice connected to and derived from the science of biology. The most important trend in biological engineering is the dynamic range of scales at which biotechnology is now able to integrate with biological processes. An explosion in micro/nanoscale technology is allowing the manufacture of nanoparticles for drug delivery into cells, miniaturized implantable microsensors for medical diagnostics, and micro-engineered robots for on-board tissue repairs. This book aims to provide an updated overview of the recent developments in biological engineering from diverse aspects and various applications in clinical and experimental research.

High Throughput Analysis in the Pharmaceutical Industry

High Throughput Analysis in the Pharmaceutical Industry Book
Author : Perry G. Wang
Publisher : CRC Press
Release : 2008-08-20
ISBN : 1420059548
Language : En, Es, Fr & De

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Book Description :

The introduction of combinatorial chemistry technology has increased the amount of compounds generated in a year from 50 to 2000. Conventional analytical approaches simply cannot keep up. These circumstances have caused drug discovery to take on the shape of a bottleneck, like traffic through a toll booth. In order to break the bottleneck, a corres

Tietz Textbook of Laboratory Medicine E Book

Tietz Textbook of Laboratory Medicine   E Book Book
Author : Nader Rifai
Publisher : Elsevier Health Sciences
Release : 2022-02-03
ISBN : 0323834671
Language : En, Es, Fr & De

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Book Description :

Use THE definitive reference for laboratory medicine and clinical pathology! Tietz Textbook of Laboratory Medicine, 7th Edition provides the guidance necessary to select, perform, and evaluate the results of new and established laboratory tests. Comprehensive coverage includes the latest advances in topics such as clinical chemistry, genetic metabolic disorders, molecular diagnostics, hematology and coagulation, clinical microbiology, transfusion medicine, and clinical immunology. From a team of expert contributors led by Nader Rifai, this reference includes access to wide-ranging online resources on Expert Consult — featuring the comprehensive product with fully searchable text, regular content updates, animations, podcasts, over 1300 clinical case studies, lecture series, and more. Authoritative, current content helps you perform tests in a cost-effective, timely, and efficient manner; provides expertise in managing clinical laboratory needs; and shows how to be responsive to an ever-changing environment. Current guidelines help you select, perform, and evaluate the results of new and established laboratory tests. Expert, internationally recognized chapter authors present guidelines representing different practices and points of view. Analytical criteria focus on the medical usefulness of laboratory procedures. Use of standard and international units of measure makes this text appropriate for any user, anywhere in the world. Expert Consult provides the entire text as a fully searchable eBook, and includes regular content updates, animations, podcasts, more than 1300 clinical case studies, over 2500 multiple-choice questions, a lecture series, and more. NEW! 19 additional chapters highlight various specialties throughout laboratory medicine. NEW! Updated, peer-reviewed content provides the most current information possible. NEW! The largest-ever compilation of clinical cases in laboratory medicine is included on Expert Consult. NEW! Over 100 adaptive learning courses on Expert Consult offer the opportunity for personalized education.

Sample Preparation for Hyphenated Analytical Techniques

Sample Preparation for Hyphenated Analytical Techniques Book
Author : Jack Rosenfeld
Publisher : John Wiley & Sons
Release : 2009-02-12
ISBN : 1405148039
Language : En, Es, Fr & De

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Book Description :

Linking “standard” but often mutually incompatible analytical techniques – so called hyphenation – generally leads to enhanced analytical performance, so hyphenated techniques are widely used in areas where samples are presented in complex matrices, eg environmental, pharmaceutical and biochemical analysis. With these hyphenated techniques, sample preparation is often the most time-consuming step in analysis, particularly where compounds are present in low concentration, and it has a huge influence on the quality of the analytical results. Sample preparation is still not given the importance it deserves, however. The purpose of this book is to demonstrate the sample preparation chemistry that has enabled the present sensitivity, specificity and high throughput available across a range of hyphenated analytical techniques, and to illustrate the successful utilization of existing sample preparation methodologies in various analytical applications. It identifies the problems in biology, environmental science and pharmaceutical chemistry that require new ideas in chemistry and provides considered opinion on those newer techniques that may address these problems. By dealing with wider issues than is generally found in review papers, this book will provide analytical chemists with insights that are not available by searching the literature for papers on a specific topic.

Sample Preparation in LC MS Bioanalysis

Sample Preparation in LC MS Bioanalysis Book
Author : Wenkui Li,Wenying Jian,Yunlin Fu
Publisher : John Wiley & Sons
Release : 2019-02-25
ISBN : 111927432X
Language : En, Es, Fr & De

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Book Description :

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.

Tietz Textbook of Clinical Chemistry and Molecular Diagnostics

Tietz Textbook of Clinical Chemistry and Molecular Diagnostics Book
Author : Nader Rifai
Publisher : Elsevier Health Sciences
Release : 2017-01-16
ISBN : 0323548482
Language : En, Es, Fr & De

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Book Description :

The Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 6th Edition provides the most current and authoritative guidance on selecting, performing, and evaluating the results of new and established laboratory tests. This classic clinical chemistry reference offers encyclopedic coverage detailing everything you need to know, including: analytical criteria for the medical usefulness of laboratory tests, variables that affect tests and results, laboratory medicine, applications of statistical methods, and most importantly clinical utility and interpretation of laboratory tests. It is THE definitive reference in clinical chemistry and molecular diagnostics, now fully searchable and with quarterly content updates, podcasts, clinical cases, animations, and extended content online through Expert Consult. Analytical criteria focus on the medical usefulness of laboratory procedures. Reference ranges show new approaches for establishing these ranges — and provide the latest information on this topic. Lab management and costs gives students and chemists the practical information they need to assess costs, allowing them to do their job more efficiently and effectively. Statistical methods coverage provides you with information critical to the practice of clinical chemistry. Internationally recognized chapter authors are considered among the best in their field. Two-color design highlights important features, illustrations, and content to help you find information easier and faster. NEW! Internationally recognized chapter authors are considered among the best in their field. NEW! Expert Consult features fully searchable text, quarterly content updates, clinical case studies, animations, podcasts, atlases, biochemical calculations, multiple-choice questions, links to Medline, an image collection, and audio interviews. You will now enjoy an online version making utility of this book even greater. UPDATED! Expanded Molecular Diagnostics section with 12 chapters that focus on emerging issues and techniques in the rapidly evolving and important field of molecular diagnostics and genetics ensures this text is on the cutting edge and of the most value. NEW! Comprehensive list of Reference Intervals for children and adults with graphic displays developed using contemporary instrumentation. NEW! Standard and international units of measure make this text appropriate for any user — anywhere in the world. NEW! 22 new chapters that focus on applications of mass spectrometry, hematology, transfusion medicine, microbiology, biobanking, biomarker utility in the pharmaceutical industry and more! NEW! Expert senior editors, Nader Rifai, Carl Wittwer and Rita Horvath, bring fresh perspectives and help ensure the most current information is presented. UPDATED! Thoroughly revised and peer-reviewed chapters provide you with the most current information possible.

Regulated Bioanalytical Laboratories

Regulated Bioanalytical Laboratories Book
Author : Michael Zhou
Publisher : John Wiley & Sons
Release : 2011-03-31
ISBN : 9780470922804
Language : En, Es, Fr & De

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Book Description :

This book provides useful information for bioanalytical / analytical scientists, analysts, quality assurance managers, and all personnel in bioanalytical laboratories through all aspects of bioanalytical technical and regulatory perspectives within bioanalytical operations and processes. Readers learn how to develop and implement strategies for routine, non-routine, and standard bioanalytical methods and on the entire equipment hardware and software qualification process. The book also gives guidelines on qualification of certified standards and in-house reference material as well as on people qualification. Finally, it guides readers through stressless internal and third party laboratory audits and inspections. It takes account to most national and international regulations and quality and accreditation standards, along with corresponding interpretation and inspection guides. The author elaborates on highly comprehensive content, making it easy not only to learn the subject but also to quickly implement the recommendations.

Principles and Applications of Clinical Mass Spectrometry

Principles and Applications of Clinical Mass Spectrometry Book
Author : Nader Rifai,A. Rita Horvath,Carl T. Wittwer,Andy Hoofnagle
Publisher : Elsevier
Release : 2018-06-26
ISBN : 0128160640
Language : En, Es, Fr & De

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Book Description :

Principles and Applications of Clinical Mass Spectrometry: Small Molecules, Peptides, and Pathogens is a concise resource for quick implementation of mass spectrometry methods in clinical laboratory work. Focusing on the practical use of these techniques, the first half of the book covers principles of chromatographic separations, principles and types of mass spectrometers, and sample preparation for analysis; the second half outlines the main applications of this technology within clinical laboratory settings, including determination of small molecules and peptides, as well as pathogen identification. A thorough yet succinct guide to using mass spectrometry technology in the clinical laboratory, Principles and Applications of Clinical Mass Spectrometry: Small Molecules, Peptides, and Pathogens is an essential resource for chemists, pharmaceutical and biotech researchers, certain government agencies, and standardization groups. Provides concrete examples of the main applications of mass spectrometry technology Describes current capabilities of the LC- and MS-based analytical methods Details methods for successful analytical work in the field

Handbook of LC MS Bioanalysis

Handbook of LC MS Bioanalysis Book
Author : Wenkui Li,Jie Zhang,Francis L. S. Tse
Publisher : John Wiley & Sons
Release : 2013-09-03
ISBN : 111867135X
Language : En, Es, Fr & De

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Book Description :

Consolidates the information LC-MS bioanalytical scientistsneed to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by newapproaches for developing bioanalytical methods, new liquidchromatographic (LC) techniques, and new mass spectrometric (MS)instruments. Moreover, there are a host of guidelines andregulations designed to ensure the quality of bioanalyticalresults. Presenting the best practices, experimental protocols, and thelatest understanding of regulations, this book offers acomprehensive review of LC-MS bioanalysis of small molecules andmacromolecules. It not only addresses the needs of bioanalyticalscientists working on routine projects, but also explores advancedand emerging technologies such as high-resolution mass spectrometryand dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions froman international team of leading bioanalytical scientists. Theircontributions reflect a review of the latest findings, practices,and regulations as well as their own firsthand analyticallaboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drugdevelopment, and therapeutic drug monitoring The current understanding of regulations governing LC-MSbioanalysis Best practices and detailed technical instructions for LC-MSbioanalysis method development, validation, and stabilityassessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MSbioanalysis of challenging molecules, including pro-drugs, acylglucuronides, N-oxides, reactive compounds, and photosensitive andautooxidative compounds With its focus on current bioanalytical practice, Handbook ofLC-MS Bioanalysis enables bioanalytical scientists to developand validate robust LC-MS assay methods, all in compliance withcurrent regulations and standards.

Liquid Chromatography Mass Spectrometry

Liquid Chromatography Mass Spectrometry Book
Author : Wilfried M.A. Niessen
Publisher : CRC Press
Release : 2006-08-09
ISBN : 1420014544
Language : En, Es, Fr & De

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Book Description :

A constructive evaluation of the most significant developments in liquid chromatography-mass spectrometry (LC-MS) and its uses for quantitative bioanalysis and characterization for a diverse range of disciplines, Liquid Chromatography-Mass Spectrometry, Third Edition offers a well-rounded coverage of the latest technological developments and

Modern Sample Preparation for Chromatography

Modern Sample Preparation for Chromatography Book
Author : Serban C. Moldoveanu,Victor David
Publisher : Elsevier
Release : 2014-10-18
ISBN : 0444543228
Language : En, Es, Fr & De

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Book Description :

Sample preparation is applied to make real world samples amenable for chromatographic analysis, or to improve the results of this type of analysis. A wide variety of procedures are applied for this purpose, and their description is the main goal of the present book. The principles of these procedures are explained, discussing their advantages and disadvantages, and their applicability to different types of samples as well as their fit for different types of chromatographic analysis. This provides a guide for choosing the appropriate sample preparation for a given analysis. The book also contains numerous literature references and examples of sample preparation for different matrices. The material is presented in three parts, one discussing physical methods used in sample preparation such as filtration, distillation, solvent extraction, solid phase extraction, electro-separations. Presents in a systematic way numerous techniques applied for sample preparation for chromatographic analysis Provides an up to date source of information regarding the progress made in sample preparation for chromatography Describes examples for specific type of matrices, providing a guide for choosing the appropriate sample preparation method for a given analysis

Principles and Practice of Bioanalysis

Principles and Practice of Bioanalysis Book
Author : Richard F. Venn
Publisher : CRC Press
Release : 2008-02-25
ISBN : 142000560X
Language : En, Es, Fr & De

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Book Description :

In the seven years since the publication of Principles and Practice of Bioanalysis bioanalytical methods have remained the same, but their usage patterns have changed. This second edition of a bestseller provides an updated guide to the techniques used in developing and running ultra-trace analyses for drugs, metabolites, and other substance

Enzyme Inhibition in Drug Discovery and Development

Enzyme Inhibition in Drug Discovery and Development Book
Author : Chuang Lu,Albert P. Li
Publisher : John Wiley & Sons
Release : 2010-01-26
ISBN : 9780470538944
Language : En, Es, Fr & De

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Book Description :

The science and applied approaches of enzyme inhibition in drug discovery and development Offering a unique approach that includes both the pharmacologic and pharmaco-kinetic aspects of enzyme inhibition, Enzyme Inhibition in Drug Discovery and Development examines the scientific concepts and experimental approaches related to enzyme inhibition as applied in drug discovery and drug development. With chapters written by over fifty leading experts in their fields, Enzyme Inhibition in Drug Discovery and Development fosters a cross-fertilization of pharmacology, drug metabolism, pharmacokinetics, and toxicology by understanding the "good" inhibitions—desirable pharmacological effects—and "bad" inhibitions—drug–drug interactions and toxicity. The book discusses: The drug discovery process, including drug discovery strategy, medicinal chemistry, analytical chemistry, drug metabolism, pharmacokinetics, and safety biomarker assessment The manipulations of drug metabolizing enzymes and transporters as well as the negative consequences, such as drug–drug interactions The inhibition of several major drug target pathways, such as the GPCR pathway, the NFkB pathway, and the ion channel pathway Through this focused, single-source reference on the fundamentals of drug discovery and development, researchers in drug metabolism and pharmacokinetics (DMPK) will learn and appreciate target biology in drug discovery; discovery biologists and medicinal chemists will also broaden their understanding of DMPK.

Integrated Strategies for Drug Discovery Using Mass Spectrometry

Integrated Strategies for Drug Discovery Using Mass Spectrometry Book
Author : Mike S. Lee
Publisher : John Wiley & Sons
Release : 2005-09-02
ISBN : 0471721026
Language : En, Es, Fr & De

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Book Description :

New strategies and techniques for today's fast-paced discoveryprocess Today, the pressure is on for high-throughput approaches toaccelerate the generation, identification, and optimization ofmolecules with desirable drug properties. As traditional methods ofanalysis become antiquated, new analytical strategies andtechniques are necessary to meet sample throughput requirements andmanpower constraints. Among them, mass spectrometry has grown to bea front-line tool throughout drug discovery. Integrated Strategies for Drug Discovery Using Mass Spectrometryprovides a thorough review of current analytical approaches,industry practices, and strategies in drug discovery. The topicsrepresent current industry benchmarks in specific drug discoveryactivities that deal with proteomics, biomarker discovery,metabonomic approaches for toxicity screening, lead identification,compound libraries, quantitative bioanalytical support,biotransformation, reactive metabolite characterization, leadoptimization, pharmaceutical property profiling, sample preparationstrategies, and automation. THIS BOOK: * Clearly explains how drug discovery and mass spectrometry areinterconnected * Discusses the uses and limitations of various types of massspectrometry in various aspects of drug discovery * Prominently features analytical applications that requiretrace-mixture analysis * Provides industry applications and real-world examples * Shares historical background information on various techniques toaid in the understanding of how and why new methods are now beingemployed to analyze samples

Mass Spectrometry Handbook

Mass Spectrometry Handbook Book
Author : Mike S. Lee
Publisher : John Wiley & Sons
Release : 2012-05-08
ISBN : 047053673X
Language : En, Es, Fr & De

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Book Description :

Due to its enormous sensitivity and ease of use, mass spectrometry has grown into the analytical tool of choice in most industries and areas of research. This unique reference provides an extensive library of methods used in mass spectrometry, covering applications of mass spectrometry in fields as diverse as drug discovery, environmental science, forensic science, clinical analysis, polymers, oil composition, doping, cellular research, semiconductor, ceramics, metals and alloys, and homeland security. The book provides the reader with a protocol for the technique described (including sampling methods) and explains why to use a particular method and not others. Essential for MS specialists working in industrial, environmental, and clinical fields.

A Handbook of Bioanalysis and Drug Metabolism

A Handbook of Bioanalysis and Drug Metabolism Book
Author : Gary Evans
Publisher : CRC Press
Release : 2021-10-15
ISBN : 1134477376
Language : En, Es, Fr & De

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Book Description :

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.

Encyclopedia of Chromatography

Encyclopedia of Chromatography Book
Author : Jack Cazes
Publisher : CRC Press
Release : 2009-10-12
ISBN : 1439870675
Language : En, Es, Fr & De

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Book Description :

Thoroughly revised and expanded, the third edition of the Encyclopedia of Chromatography is an authoritative source of information for researchers in chemistry, biology, physics, engineering, and materials science. This quick reference and guide to specific chromatographic techniques and theory provides a basic introduction to the science and techn

Preclinical Development Handbook

Preclinical Development Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 0470249021
Language : En, Es, Fr & De

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Book Description :

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Targeted Biomarker Quantitation by LC MS

Targeted Biomarker Quantitation by LC MS Book
Author : Naidong Weng,Wenying Jian
Publisher : John Wiley & Sons
Release : 2017-07-05
ISBN : 1119413060
Language : En, Es, Fr & De

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Book Description :

The first book to offer a blueprint for overcoming the challenges to successfully quantifying biomarkers in living organisms The demand among scientists and clinicians for targeted quantitation experiments has experienced explosive growth in recent years. While there are a few books dedicated to bioanalysis and biomarkers in general, until now there were none devoted exclusively to addressing critical issues surrounding this area of intense research. Target Biomarker Quantitation by LC-MS provides a detailed blueprint for quantifying biomarkers in biological systems. It uses numerous real-world cases to exemplify key concepts, all of which were carefully selected and presented so as to allow the concepts they embody to be easily expanded to future applications, including new biomarker development. Target Biomarker Quantitation by LC-MS primarily focuses on the assay establishment for biomarker quantitation—a critical issue rarely treated in depth. It offers comprehensive coverage of three core areas of biomarker assay establishment: the relationship between the measured biomarkers and their intended usage; contemporary regulatory requirements for biomarker assays (a thorough understanding of which is essential to producing a successful and defendable submission); and the technical challenges of analyzing biomarkers produced inside a living organism or cell. Covers the theory of and applications for state-of-the-art mass spectrometry and chromatography and their applications in biomarker analysis Features real-life examples illustrating the challenges involved in target biomarker quantitation and the innovative approaches which have been used to overcome those challenges Addresses potential obstacles to obtain effective biomarker level and data interpretation, such as specificity establishment and sample collection Outlines a tiered approach and fit-for-purpose assay protocol for target biomarker quantitation Highlights the current state of the biomarker regulatory environment and protocol standards Target Biomarker Quantitation by LC-MS is a valuable resource for bioanalytical scientists, drug metabolism and pharmacokinetics scientists, clinical scientists, analytical chemists, and others for whom biomarker quantitation is an important tool of the trade. It also functions as an excellent text for graduate courses in pharmaceutical, biochemistry and chemistry.