Bioanalytical Aspects In Biological Therapeutics

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Bioanalytical Aspects in Biological Therapeutics

Author : Xiaohui (Sophia) Xu
Publisher : John Wiley & Sons
ISBN 13 : 1119523214
Total Pages : 404 pages
Book Rating : 4.1/5 (195 download)

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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.

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.

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.

Regulated Bioanalysis: Fundamentals and Practice

Author : Mario L. Rocci Jr.
Publisher : Springer
ISBN 13 : 3319548026
Total Pages : 239 pages
Book Rating : 4.3/5 (195 download)

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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 239 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.

Regulated Bioanalytical Laboratories

Author : Michael Zhou
Publisher : John Wiley & Sons
ISBN 13 : 047092280X
Total Pages : 564 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Regulated Bioanalytical Laboratories by : Michael Zhou

Download or read book Regulated Bioanalytical Laboratories written by Michael Zhou and published by John Wiley & Sons. This book was released on 2011-03-31 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Bioanalysis of Pharmaceuticals

Author : Steen Honor? Hansen
Publisher : Wiley
ISBN 13 : 9781118716885
Total Pages : 336 pages
Book Rating : 4.7/5 (168 download)

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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.

Bioanalytical Chemistry

Author : Susan R. Mikkelsen
Publisher : Wiley
ISBN 13 : 9781119057635
Total Pages : 488 pages
Book Rating : 4.0/5 (576 download)

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Book Synopsis Bioanalytical Chemistry by : Susan R. Mikkelsen

Download or read book Bioanalytical Chemistry written by Susan R. Mikkelsen and published by Wiley. This book was released on 2016-02-16 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: A timely, accessible survey of the multidisciplinary field of bioanalytical chemistry Provides an all in one approach for both beginners and experts, from a broad range of backgrounds, covering introductions, theory, advanced concepts and diverse applications for each method Each chapter progresses from basic concepts to applications involving real samples Includes three new chapters on Biomimetic Materials, Lab-on-Chip, and Analytical Methods Contains end-of-chapter problems and an appendix with selected answers

Pharmaceutical Biotechnology

Author : Oliver Kayser
Publisher : John Wiley & Sons
ISBN 13 : 3527329943
Total Pages : 677 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Pharmaceutical Biotechnology by : Oliver Kayser

Download or read book Pharmaceutical Biotechnology written by Oliver Kayser and published by John Wiley & Sons. This book was released on 2012-05-21 with total page 677 pages. Available in PDF, EPUB and Kindle. Book excerpt: This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.

Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology

Author : Alexandru Mihai Grumezescu
Publisher : William Andrew
ISBN 13 : 0128136308
Total Pages : 704 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology by : Alexandru Mihai Grumezescu

Download or read book Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology written by Alexandru Mihai Grumezescu and published by William Andrew. This book was released on 2017-12-11 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology focuses on the fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. In particular, the following aspects of nanoparticle preparation methods are discussed: the need for less toxic reagents, simplification of the procedure to allow economic scale-up, and optimization to improve yield and entrapment efficiency. Written by a diverse range of international researchers, the chapters examine characterization and manufacturing of nanomaterials for pharmaceutical applications. Regulatory and policy aspects are also discussed. This book is a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about how nanomaterials can best be utilized. Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry

Analytical Techniques in Biosciences

Author : Chukwuebuka Egbuna
Publisher : Academic Press
ISBN 13 : 0128227990
Total Pages : 302 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Analytical Techniques in Biosciences by : Chukwuebuka Egbuna

Download or read book Analytical Techniques in Biosciences written by Chukwuebuka Egbuna and published by Academic Press. This book was released on 2021-10-21 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: Analytical Techniques in Biosciences: From Basics to Applications presents comprehensive and up-to-date information on the various analytical techniques obtainable in bioscience research laboratories across the world. This book contains chapters that discuss the basic bioanalytical protocols and sample preparation guidelines. Commonly encountered analytical techniques, their working principles, and applications were presented. Techniques, considered in this book, include centrifugation techniques, electrophoretic techniques, chromatography, titrimetry, spectrometry, and hyphenated techniques. Subsequent chapters emphasize molecular weight determination and electroanalytical techniques, biosensors, and enzyme assay protocols. Other chapters detail microbial techniques, statistical methods, computational modeling, and immunology and immunochemistry. The book draws from experts from key institutions around the globe, who have simplified the chapters in a way that will be useful to early-stage researchers as well as advanced scientists. It is also carefully structured and integrated sequentially to aid flow, consistency, and continuity. This is a must-have reference for graduate students and researchers in the field of biosciences. Presents basic analytical protocols and sample-preparation guidelines Details the various analytical techniques, including centrifugation, spectrometry, chromatography, and titrimetry Describes advanced techniques such as hyphenated techniques, electroanalytical techniques, and the application of biosensors in biomedical research Presents biostatistical tools and methods and basic computational models in biosciences

Biosimilars of Monoclonal Antibodies

Author : Cheng Liu
Publisher : John Wiley & Sons
ISBN 13 : 1118940628
Total Pages : 723 pages
Book Rating : 4.1/5 (189 download)

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Book Synopsis Biosimilars of Monoclonal Antibodies by : Cheng Liu

Download or read book Biosimilars of Monoclonal Antibodies written by Cheng Liu and published by John Wiley & Sons. This book was released on 2016-12-09 with total page 723 pages. Available in PDF, EPUB and Kindle. Book excerpt: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs

Handbook of Drug Monitoring Methods

Author : Amitava Dasgupta
Publisher : Springer Science & Business Media
ISBN 13 : 1588297802
Total Pages : 441 pages
Book Rating : 4.5/5 (882 download)

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Book Synopsis Handbook of Drug Monitoring Methods by : Amitava Dasgupta

Download or read book Handbook of Drug Monitoring Methods written by Amitava Dasgupta and published by Springer Science & Business Media. This book was released on 2007-10-23 with total page 441 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written in a handbook style with specific methods and tips on eliminating false positive and false negative results, this book is a practical guide to the detailed mechanisms of such occurrences.

Oligonucleotide-Based Drugs and Therapeutics

Author : Nicolay Ferrari
Publisher : John Wiley & Sons
ISBN 13 : 1118537335
Total Pages : 576 pages
Book Rating : 4.1/5 (185 download)

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Book Synopsis Oligonucleotide-Based Drugs and Therapeutics by : Nicolay Ferrari

Download or read book Oligonucleotide-Based Drugs and Therapeutics written by Nicolay Ferrari and published by John Wiley & Sons. This book was released on 2018-07-31 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive review of contemporary antisense oligonucleotides drugs and therapeutic principles, methods, applications, and research Oligonucleotide-based drugs, in particular antisense oligonucleotides, are part of a growing number of pharmaceutical and biotech programs progressing to treat a wide range of indications including cancer, cardiovascular, neurodegenerative, neuromuscular, and respiratory diseases, as well as other severe and rare diseases. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide covering all key aspects of this increasingly popular area of pharmacology and biotech and pharma research, from the basic science behind antisense oligonucleotides chemistry, toxicology, manufacturing, to safety assessments, the design of therapeutic protocols, to clinical experience. Antisense oligonucleotides are single strands of DNA or RNA that are complementary to a chosen sequence. While the idea of antisense oligonucleotides to target single genes dates back to the 1970's, most advances have taken place in recent years. The increasing number of antisense oligonucleotide programs in clinical development is a testament to the progress and understanding of pharmacologic, pharmacokinetic, and toxicologic properties as well as improvement in the delivery of oligonucleotides. This valuable book reviews the fundamentals of oligonucleotides, with a focus on antisense oligonucleotide drugs, and reports on the latest research underway worldwide. • Helps readers understand antisense molecules and their targets, biochemistry, and toxicity mechanisms, roles in disease, and applications for safety and therapeutics • Examines the principles, practices, and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides • Provides guidelines for scientists in drug design and discovery to help improve efficiency, assessment, and the success of drug candidates • Includes interdisciplinary perspectives, from academia, industry, regulatory and from the fields of pharmacology, toxicology, biology, and medicinal chemistry Oligonucleotide-Based Drugs and Therapeutics belongs on the reference shelves of chemists, pharmaceutical scientists, chemical biologists, toxicologists and other scientists working in the pharmaceutical and biotechnology industries. It will also be a valuable resource for regulatory specialists and safety assessment professionals and an important reference for academic researchers and post-graduates interested in therapeutics, antisense therapy, and oligonucleotides.

Targeted Biomarker Quantitation by LC-MS

Author : Naidong Weng
Publisher : John Wiley & Sons
ISBN 13 : 1119103061
Total Pages : 397 pages
Book Rating : 4.1/5 (191 download)

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Book Synopsis Targeted Biomarker Quantitation by LC-MS by : Naidong Weng

Download or read book Targeted Biomarker Quantitation by LC-MS written by Naidong Weng and published by John Wiley & Sons. This book was released on 2017-07-31 with total page 397 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biomarkers in Drug Development

Author : Michael R. Bleavins
Publisher : John Wiley & Sons
ISBN 13 : 1118210425
Total Pages : 559 pages
Book Rating : 4.1/5 (182 download)

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Book Synopsis Biomarkers in Drug Development by : Michael R. Bleavins

Download or read book Biomarkers in Drug Development written by Michael R. Bleavins and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 559 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.

Recent Advances in Analytical Chemistry

Author : Muharrem Ince
Publisher : BoD – Books on Demand
ISBN 13 : 1789858097
Total Pages : 164 pages
Book Rating : 4.7/5 (898 download)

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Book Synopsis Recent Advances in Analytical Chemistry by : Muharrem Ince

Download or read book Recent Advances in Analytical Chemistry written by Muharrem Ince and published by BoD – Books on Demand. This book was released on 2019-04-10 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book focuses on recent and future trends in analytical methods and provides an overview of analytical chemistry. As a comprehensive analytical chemistry book, it takes a broad view of the subject and integrates a wide variety of approaches. The book provides separation approaches and method validation, as well as recent developments and applications in analytical chemistry. It is written primarily for researchers in the fields of analytical chemistry, environmental chemistry, and applied chemistry. The aim of the book is to explain the subject, clarify important studies, and compare and develop new and groundbreaking applications. Written by leading experts in their respective areas, the book is highly recommended for professionals interested in analytical chemistry because it provides specific and comprehensive examples.

Evolution of Translational Omics

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309224187
Total Pages : 354 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Evolution of Translational Omics by : Institute of Medicine

Download or read book Evolution of Translational Omics written by Institute of Medicine and published by National Academies Press. This book was released on 2012-09-13 with total page 354 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technologies collectively called omics enable simultaneous measurement of an enormous number of biomolecules; for example, genomics investigates thousands of DNA sequences, and proteomics examines large numbers of proteins. Scientists are using these technologies to develop innovative tests to detect disease and to predict a patient's likelihood of responding to specific drugs. Following a recent case involving premature use of omics-based tests in cancer clinical trials at Duke University, the NCI requested that the IOM establish a committee to recommend ways to strengthen omics-based test development and evaluation. This report identifies best practices to enhance development, evaluation, and translation of omics-based tests while simultaneously reinforcing steps to ensure that these tests are appropriately assessed for scientific validity before they are used to guide patient treatment in clinical trials.