Regulated Bioanalysis: Fundamentals and Practice PDF Download
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Author: Mario L. Rocci Jr.
Publisher: Springer
ISBN: 3319548026
Category : Medical
Languages : en
Pages : 239
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Book Description
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.
Author: Mario L. Rocci Jr.
Publisher: Springer
ISBN: 3319548026
Category : Medical
Languages : en
Pages : 239
Get Book Here
Book Description
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.
Author: Wenkui Li
Publisher: John Wiley & Sons
ISBN: 111867135X
Category : Science
Languages : en
Pages : 709
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Book Description
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.
Author: Georg Hempel
Publisher: Elsevier
ISBN: 0444640673
Category : Science
Languages : en
Pages : 382
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Book Description
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
Author: Xiaohui (Sophia) Xu
Publisher: John Wiley & Sons
ISBN: 1119523281
Category : Science
Languages : en
Pages : 404
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Book Description
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.
Author: Michael Zhou
Publisher: John Wiley & Sons
ISBN: 047092280X
Category : Science
Languages : en
Pages : 564
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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.
Author: Chris Bird
Publisher: Cambridge University Press
ISBN: 1107782546
Category : Science
Languages : en
Pages : 475
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Book Description
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.
Author: Beate Escher
Publisher: IWA Publishing
ISBN: 1843393689
Category : Science
Languages : en
Pages : 273
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Book Description
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
Author: Gérald Thouand
Publisher: Springer
ISBN: 3319274074
Category : Science
Languages : en
Pages : 202
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Book Description
This book review series presents current trends in modern biotechnology. The aim is to cover all aspects of this interdisciplinary technology where knowledge, methods and expertise are required from chemistry, biochemistry, microbiology, genetics, chemical engineering and computer science. Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English. /div
Author: Binghe Wang
Publisher: John Wiley & Sons
ISBN: 1118833368
Category : Science
Languages : en
Pages : 740
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Book Description
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
Author: Chung Chow Chan
Publisher: John Wiley & Sons
ISBN: 047146371X
Category : Science
Languages : en
Pages : 320
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Book Description
Validation describes the procedures used to analyze pharmaceutical products so that the data generated will comply with the requirements of regulatory bodies of the US, Canada, Europe and Japan. Calibration of Instruments describes the process of fixing, checking or correcting the graduations of instruments so that they comply with those regulatory bodies. This book provides a thorough explanation of both the fundamental and practical aspects of biopharmaceutical and bioanalytical methods validation. It teaches the proper procedures for using the tools and analysis methods in a regulated lab setting. Readers will learn the appropriate procedures for calibration of laboratory instrumentation and validation of analytical methods of analysis. These procedures must be executed properly in all regulated laboratories, including pharmaceutical and biopharmaceutical laboratories, clinical testing laboratories (hospitals, medical offices) and in food and cosmetic testing laboratories.
