Bioanalytical Aspects in Biological Therapeutics
Bioanalytical Aspects in Biological Therapeutics

Author: Xiaohui (Sophia) Xu

Publisher: John Wiley & Sons

Published: 2022-08-23

Total Pages: 404

ISBN-13: 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.

Regulated Bioanalysis: Fundamentals and Practice
Regulated Bioanalysis: Fundamentals and Practice

Author: Mario L. Rocci Jr.

Publisher: Springer

Published: 2017-04-24

Total Pages: 239

ISBN-13: 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.

Pharmaceutical Biotechnology
Pharmaceutical Biotechnology

Author: Oliver Kayser

Publisher: John Wiley & Sons

Published: 2012-05-21

Total Pages: 677

ISBN-13: 3527329943

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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.

Analytical Techniques in Biosciences
Analytical Techniques in Biosciences

Author: Chukwuebuka Egbuna

Publisher: Academic Press

Published: 2021-10-21

Total Pages: 302

ISBN-13: 0128227990

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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

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

Author: Alexandru Mihai Grumezescu

Publisher: William Andrew

Published: 2017-12-11

Total Pages: 704

ISBN-13: 0128136308

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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

Evolution of Translational Omics
Evolution of Translational Omics

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-09-13

Total Pages: 354

ISBN-13: 0309224187

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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.

Regulated Bioanalytical Laboratories
Regulated Bioanalytical Laboratories

Author: Michael Zhou

Publisher: John Wiley & Sons

Published: 2011-03-31

Total Pages: 564

ISBN-13: 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.

Oligonucleotide-Based Drugs and Therapeutics
Oligonucleotide-Based Drugs and Therapeutics

Author: Nicolay Ferrari

Publisher: John Wiley & Sons

Published: 2018-07-31

Total Pages: 576

ISBN-13: 1118537335

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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.

Anticancer Therapeutics
Anticancer Therapeutics

Author: Adam Todd

Publisher: John Wiley & Sons

Published: 2018-02-20

Total Pages: 446

ISBN-13: 111862212X

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An integrated presentation of the basic science and clinical applications of anticancer agents Aimed at both undergraduate and postgraduate readers, this unique text provides readers with a fully-integrated presentation of all aspects of the science of anticancer drugs, including their chemistry, pharmacology, and clinical applications. After heart disease, cancer is the number one killer worldwide, and the tumor microenvironment is forever changing, creating an ever-greater demand for safer, more effective anticancer agents. In response to that demand, the $100 billion cancer drug market continues to grow, with our increased understanding of cancer leading to new drugs being used clinically almost every year. Anticancer Therapeutics is divided into three sections. Section 1 is an introduction to cancer and therapeutics, and covers the etiology and cellular and molecular basis of cancer. In Section 2, the authors focus on the anticancer agents — their discovery, synthesis, mode of action, mechanisms of resistance, and adverse reactions. Section 3 focuses on specific cancers, explaining how and why the various agents discussed in Section 2 are used, both individually and in combination, to treat different cancers. Integrates aspects of basic science, including chemistry and pharmacology and clinical medicine in relation to cancer therapeutics Written by an author team comprising specialists in medicinal chemistry, pharmacology, and oncology Features full-color images throughout illustrating how drugs bind to cellular targets and exert their pharmacological effect Divided into three sections, covering the etiology and cellular and molecular basis of cancer, anticancer agents, and drug applications for different cancers. Providing the reader with an integrated understanding of all aspects of the science of anticancer agents, this is an ideal textbook for undergraduates studying medicine, nursing, medicinal chemistry, pharmacy, pharmacology and other allied heath / life sciences. It is also a valuable bench reference for pharmacists, medics, and pharmaceutical researchers working in both academia and industry.

Handbook of Drug Monitoring Methods
Handbook of Drug Monitoring Methods

Author: Amitava Dasgupta

Publisher: Springer Science & Business Media

Published: 2007-10-23

Total Pages: 441

ISBN-13: 1588297802

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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.