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Regulated Bioanalysis: Fundamentals and Practice

Regulated Bioanalysis: Fundamentals and Practice
Author: Mario L. Rocci Jr.
Publisher: Springer
Total Pages: 230
Release: 2017-04-24
Genre: Medical
ISBN: 3319548026
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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

Regulated Bioanalytical Laboratories
Author: Michael Zhou
Publisher: John Wiley & Sons
Total Pages: 564
Release: 2011-03-31
Genre: Science
ISBN: 047092280X
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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.

Bioanalytical Aspects in Biological Therapeutics

Bioanalytical Aspects in Biological Therapeutics
Author: Xiaohui (Sophia) Xu
Publisher: John Wiley & Sons
Total Pages: 404
Release: 2022-07-06
Genre: Science
ISBN: 1119523281
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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.

Handbook of LC-MS Bioanalysis

Handbook of LC-MS Bioanalysis
Author: Wenkui Li
Publisher: John Wiley & Sons
Total Pages: 709
Release: 2013-09-03
Genre: Science
ISBN: 111867135X
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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.

Methods of Therapeutic Drug Monitoring Including Pharmacogenetics

Methods of Therapeutic Drug Monitoring Including Pharmacogenetics
Author: Georg Hempel
Publisher: Elsevier
Total Pages: 380
Release: 2019-10-17
Genre: Science
ISBN: 0444640673
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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

Principles and Practice of Bioanalysis

Principles and Practice of Bioanalysis
Author: Richard F. Venn
Publisher: CRC Press
Total Pages: 340
Release: 2008-02-25
Genre: Medical
ISBN: 142000560X
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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

Bioanalytical Aspects in Biological Therapeutics

Bioanalytical Aspects in Biological Therapeutics
Author: Xiaohui (Sophia) Xu
Publisher: John Wiley & Sons
Total Pages: 404
Release: 2022-08-23
Genre: Science
ISBN: 1119523214
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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.

Flow Cytometry

Flow Cytometry
Author: Alice Longobardi Givan
Publisher: John Wiley & Sons
Total Pages: 309
Release: 2013-04-10
Genre: Science
ISBN: 1118688392
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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.

Assay Development

Assay Development
Author: Ge Wu
Publisher: John Wiley & Sons
Total Pages: 450
Release: 2010-04-26
Genre: Science
ISBN: 0470191155
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Essential principles and practice of assay development The first comprehensive, integrated treatment of the subject, Assay Development: Fundamentals and Practices covers the essentials and techniques involved in carrying out an assay project in either a biotechnology/drug discovery setting or a platform setting. Rather than attempting comprehensive coverage of all assay development technologies, the book introduces the most widely used assay development technologies and illustrates the art of assay development through a few commonly encountered biological targets in assay development (e.g., proteases, kinases, ion channels, and G protein-coupled receptors). Just enough biological background for these biological targets is provided so that the reader can follow the logics of assay development. Chapters discuss: The basics of assay development, including foundational concepts and applications Commonly used instrumental methods for both biochemical assays and cell-based assays Assay strategies for protein binding and enzymatic activity Cell-based assays High-throughput screening An in-depth study of the now popular Caliper's off-chip kinase assay provides an instructive, real-world example of the assay development process.