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Regulated Bioanalysis Fundamentals And Practice
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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.
Book Synopsis Handbook of LC-MS Bioanalysis by : Wenkui Li
Download or read book Handbook of LC-MS Bioanalysis written by Wenkui Li and published by John Wiley & Sons. This book was released on 2013-09-03 with total page 709 pages. Available in PDF, EPUB and Kindle. Book excerpt: Consolidates the information LC-MS bioanalytical scientists need to analyze small molecules and macromolecules The field of bioanalysis has advanced rapidly, propelled by new approaches for developing bioanalytical methods, new liquid chromatographic (LC) techniques, and new mass spectrometric (MS) instruments. Moreover, there are a host of guidelines and regulations designed to ensure the quality of bioanalytical results. Presenting the best practices, experimental protocols, and the latest understanding of regulations, this book offers a comprehensive review of LC-MS bioanalysis of small molecules and macromolecules. It not only addresses the needs of bioanalytical scientists working on routine projects, but also explores advanced and emerging technologies such as high-resolution mass spectrometry and dried blood spot microsampling. Handbook of LC-MS Bioanalysis features contributions from an international team of leading bioanalytical scientists. Their contributions reflect a review of the latest findings, practices, and regulations as well as their own firsthand analytical laboratory experience. The book thoroughly examines: Fundamentals of LC-MS bioanalysis in drug discovery, drug development, and therapeutic drug monitoring The current understanding of regulations governing LC-MS bioanalysis Best practices and detailed technical instructions for LC-MS bioanalysis method development, validation, and stability assessment of analyte(s) of interest Experimental guidelines and protocols for quantitative LC-MS bioanalysis of challenging molecules, including pro-drugs, acyl glucuronides, N-oxides, reactive compounds, and photosensitive and autooxidative compounds With its focus on current bioanalytical practice, Handbook of LC-MS Bioanalysis enables bioanalytical scientists to develop and validate robust LC-MS assay methods, all in compliance with current regulations and standards.
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 2022-07-06 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.
Book Synopsis Methods of Therapeutic Drug Monitoring Including Pharmacogenetics by : Georg Hempel
Download or read book Methods of Therapeutic Drug Monitoring Including Pharmacogenetics written by Georg Hempel and published by Elsevier. This book was released on 2019-10-17 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Methods of Therapeutic Drug Monitoring Including Pharmacogenetics, Second Edition, Volume Seven in the Handbook of Analytical Separations series, covers all aspects of drug monitoring, including laboratory work, pharmacokinetic analysis and clinical aspects, thus enabling readers from different fields to understand the whole process of therapeutic drug monitoring and how to avoid common pitfalls. The book contains analytical techniques for the quantification of drugs, along with pharmacogenetic and pharmacogenomic methods. Also included are updates on sample preparation, including dried blood spot technology and microextraction methods. In addition, the book includes new drugs, such as tyrosine kinase inhibitors and the monitoring of immunosuppressant drugs. - Presents a unique, interdisciplinary approach that appeals to a wide range of users - Written by authors from international labs, providing a global perspective that can be applied in various regulatory environments - Features additional therapeutic drugs to reflect the rising number of immunocompromised patients - Includes a new mass spectroscopic methods chapter to capture the frequent use in TDM and the improved availability of LC-MS across laboratories
Book Synopsis Antibody-Drug Conjugates by : Kenneth J. Olivier, Jr.
Download or read book Antibody-Drug Conjugates written by Kenneth J. Olivier, Jr. and published by John Wiley & Sons. This book was released on 2016-11-14 with total page 474 pages. Available in PDF, EPUB and Kindle. Book excerpt: Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development
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.
Book Synopsis Bioanalytical Tools in Water Quality Assessment by : Beate Escher
Download or read book Bioanalytical Tools in Water Quality Assessment written by Beate Escher and published by IWA Publishing. This book was released on 2011-12-15 with total page 273 pages. Available in PDF, EPUB and Kindle. Book excerpt: Part of Water Quality Set - Buy all four books and save over 30% on buying separately! Bioanalytical Tools in Water Quality Assessment reviews the application of bioanalytical tools to the assessment of water quality including surveillance monitoring. The types of water included range from wastewater to drinking water, including recycled water, as well as treatment processes and advanced water treatment. Bioanalytical Tools in Water Quality Assessment not only demonstrates applications but also fills in the background knowledge in toxicology/ecotoxicology needed to appreciate these applications. Each chapter summarises fundamental material in a targeted way so that information can be applied to better understand the use of bioanalytical tools in water quality assessment. Bioanalytical tools in Water Quality Assessment can be used by lecturers teaching academic and professional courses and also by risk assessors, regulators, experts, consultants, researchers and managers working in the water sector. It can also be a reference manual for environmental engineers, analytical chemists, and toxicologists. Authors: Beate Escher, National Research Centre for Environmental Toxicology (EnTox), The University of Queensland, Australia, Frederic Leusch, Smart Water Research Facility (G51), Griffith University Gold Coast Campus, Australia. With contributions by Heather Chapman and Anita Poulsen
Book Synopsis The Fundamentals of Horticulture by : Chris Bird
Download or read book The Fundamentals of Horticulture written by Chris Bird and published by Cambridge University Press. This book was released on 2014-04-24 with total page 475 pages. Available in PDF, EPUB and Kindle. Book excerpt: Essential reading for all studying horticulture and keen gardeners. This clear introduction to the principles underlying the practical applications of horticulture opens up the excitement of growing plants and garden development without readers wading through complex information. Written by a team of highly motivated and experienced horticultural tutors, the text supports the newly restructured RHS Level 2 qualifications with related Level 3 topics in boxes and signposting to Level 4 topics, together with other horticultural qualifications at these levels. Full colour images tied closely to the text and practical case study boxes inspire readers by making topics relevant to their own horticultural experiences. A comprehensive glossary helps build confidence in the use of classical horticulture language as well as new developing terms, and end-of-chapter questions encourage readers to apply what they have learnt. Extensive online supporting material includes mind maps showing the relationship of topics and aiding students in revision.
Book Synopsis Antibody-Drug Conjugates by : Jeffrey Wang
Download or read book Antibody-Drug Conjugates written by Jeffrey Wang and published by Springer. This book was released on 2015-03-05 with total page 248 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.
Book Synopsis Immunoassay and Other Bioanalytical Techniques by : Jeanette M. van Emon
Download or read book Immunoassay and Other Bioanalytical Techniques written by Jeanette M. van Emon and published by CRC Press. This book was released on 2016-04-19 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: Taking an interdisciplinary approach that emphasizes the adaptability of immunochemical and related bioanalytical methods to a variety of matrices, Immunoassay and Other Bioanalytical Techniques describes the strength and the versatility of these methods in a wide range of environmental and biological measurement applications. With contribut
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.
Book Synopsis Analytical Techniques in the Pharmaceutical Sciences by : Anette Müllertz
Download or read book Analytical Techniques in the Pharmaceutical Sciences written by Anette Müllertz and published by Springer. This book was released on 2016-08-30 with total page 829 pages. Available in PDF, EPUB and Kindle. Book excerpt: The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this formulation responds in different biological environments. To achieve this, there is a wide range of analytical techniques that can be adopted to understand and elucidate the mechanics of drug delivery and drug formulation. Such methods include e.g. spectroscopic analysis, diffractometric analysis, thermal investigations, surface analytical techniques, particle size analysis, rheological techniques, methods to characterize drug stability and release, and biological analysis in appropriate cell and animal models. Whilst each of these methods can encompass a full research area in their own right, formulation scientists must be able to effectively apply these methods to the delivery system they are considering. The information in this book is designed to support researchers in their ability to fully characterize and analyze a range of delivery systems, using an appropriate selection of analytical techniques. Due to its consideration of regulatory approval, this book will also be suitable for industrial researchers both at early stage up to pre-clinical research.
Book Synopsis Molecular Biotechnology by : Bernard R. Glick
Download or read book Molecular Biotechnology written by Bernard R. Glick and published by . This book was released on 1998 with total page 724 pages. Available in PDF, EPUB and Kindle. Book excerpt: The second edition explains the principles of recombinant DNA technology as well as other important techniques such as DNA sequencing, the polymerase chain reaction, and the production of monclonal antibodies.
Book Synopsis Fundamentals of Analytical Toxicology by : Robert J. Flanagan
Download or read book Fundamentals of Analytical Toxicology written by Robert J. Flanagan and published by John Wiley & Sons. This book was released on 2008-03-03 with total page 605 pages. Available in PDF, EPUB and Kindle. Book excerpt: The analytical toxicologist may be required to detect, identify, and in many cases measure a wide variety of compounds in samples from almost any part of the body or in related materials such as residues in syringes or in soil. This book gives principles and practical information on the analysis of drugs and poisons in biological specimens, particularly clinical and forensic specimens. After providing some background information the book covers aspects of sample collection, transport, storage and disposal, and sample preparation. Analytical techniques - colour tests and spectrophotometry, chromatography and electrophoresis, mass spectrometry, and immunoassay – are covered in depth, and a chapter is devoted to the analysis of trace elements and toxic metals. General aspects of method implementation/validation and laboratory operation are detailed, as is the role of the toxicology laboratory in validating and monitoring the performance of point of care testing (POCT) devices. The book concludes with reviews of xenobiotic absorption, distribution and metabolism, pharmacokinetics, and general aspects of the interpretation of analytical toxicology results. A clearly written, practical, integrated approach to the basics of analytical toxicology. Focuses on analytical, statistical and pharmacokinetic principles rather than detailed applications. Assumes only a basic knowledge of analytical chemistry. An accompanying website provides additional material and links to related sites. Written by an experienced team of authors,Fundamentals of Analytical Toxicology is an invaluable resource for those starting out in a career in analytical toxicology across a wide range of disciplines including clinical and forensic science, food safety, and pharmaceutical development. Praise from the reviews: “This is an ambitious effort to describe in detail the many and varied aspects of the science of toxicological analysis. The 17 chapters cover every foreseeable aspect, from specimen collection through analytical techniques and quality control to pharmacological principles and interpretation of results. The authors bring together a great deal of experience in the field and have succeeded admirably in achieving their goal: "to give principles and practical information on the analysis of drugs, poisons and other relevant analytes in biological specimens...". The book is very readable and quite up-to-date, and contains many illustrative figures, charts and tables. Both the student and the practicing professional would do well to study this material carefully, as there is something here for every conceivable level of interest.” Review from Randall Baselt "This text comes highly recommended for any analytical toxicology trainee." The Bulletin of the Royal College of Pathologists “Overall, this book provides a comprehensive, thorough, clear, up to date and practical treatment of analytical toxicology at a high standard. Understanding of the text is enhanced by the use of many illustrations. Specifications, guidelines, and methods are highlighted in grey background “Boxes”. The many and up to date literature references in each chapter demonstrate the authors’ thorough work and permit easy access to deeper information. Therefore this book can be highly recommended as a valuable source of knowledge in analytical toxicology both as an introduction and for the advanced reader.” GTFCh Bulletin “Toxichem + Krimtech”, May 2008 (translated, original review in German) “Many toxicologists will add this important reference to their libraries because it competently fills a need ...” International Journal of Toxicology “The book is very well illustrated, easy to understand and pleasant to read, and contains a wealth of dedicated information.” International Journal of Environmental Analytical Chemistry
Book Synopsis Photoelectrochemical Bioanalysis by : Muhammad Altaf
Download or read book Photoelectrochemical Bioanalysis written by Muhammad Altaf and published by Elsevier. This book was released on 2023-08-24 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: Photoelectrochemical Bioanalysis: Fundamentals and Emerging Applications covers the fundamentals from a basic to advanced level, along with the latest accounting of emerging applications. As photoelectrochemical bioanalysis is a rapidly developing area with a wide range developments occurring alongside, it can be difficult for beginners to grasp the understanding of the ever-growing and continuously expanding body of knowledge. Sections detail information on applications in bioanalysis, their working principles, the methodologies of constructions and the approaches adopted with their respective advantages and disadvantages. This book will assist researchers in understanding the latest advances in the materials and engineering aspects of PCE bioanalysis. It also provides researchers with an overview of modern strategies applied for the performance enhancement of PCE materials as well as the modifications suggested to improve the potential of PCE bioanalytical techniques. Last but not least, it will assist researchers in finding gaps and potential opportunities in the field to impart novelty in their research - Provides concise explanation of the principles and chemistry involved in PCE bioanalysis - Offers a comprehensive account of materials used for PCE bioanalytical application - Details extensive coverage to the potential applications of PCE bioanalysis
Download or read book Drug Delivery written by Binghe Wang and published by John Wiley & Sons. This book was released on 2016-04-18 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: Following its successful predecessor, this book covers the fundamentals, delivery routes and vehicles, and practical applications of drug delivery. In the 2nd edition, almost all chapters from the previous are retained and updated and several new chapters added to make a more complete resource and reference. • Helps readers understand progress in drug delivery research and applications • Updates and expands coverage to reflect advances in materials for delivery vehicles, drug delivery approaches, and therapeutics • Covers recent developments including transdermal and mucosal delivery, lymphatic system delivery, theranostics • Adds new chapters on nanoparticles, controlled drug release systems, theranostics, protein and peptide drugs, and biologics delivery
Book Synopsis Concepts and Principles of Pharmacology by : James E. Barrett
Download or read book Concepts and Principles of Pharmacology written by James E. Barrett and published by Springer Nature. This book was released on 2019-12-24 with total page 457 pages. Available in PDF, EPUB and Kindle. Book excerpt: Celebrating 100 years of HEP, this volume will discuss key pharmacological discoveries and concepts of the past 100 years. These discoveries have dramatically changed the medical treatment paradigms of many diseases and these concepts have and will continue to shape discovery of new medicinies. Newly evolving technologies will similarly be discussed as they will shape the future of the pharmacology and, accordingly, medical therapy.
