Validation Of Cell Based Assays In The Glp Setting

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Validation of Cell-Based Assays in the GLP Setting

Author : Uma Prabhakar
Publisher : John Wiley & Sons
ISBN 13 : 9780470987803
Total Pages : 312 pages
Book Rating : 4.9/5 (878 download)

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Book Synopsis Validation of Cell-Based Assays in the GLP Setting by : Uma Prabhakar

Download or read book Validation of Cell-Based Assays in the GLP Setting written by Uma Prabhakar and published by John Wiley & Sons. This book was released on 2008-04-30 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of cell-based assays within pharmaceutical and biotechnology companies is driven in large part by the need to evaluate the plethora of drug targets derived from genomics and proteomics. In addition, the potential of biomarkers to facilitate the development of effective and safe drugs is being recognized as an integral part of all phases of drug development, and cell-based technologies are a critical part of biomarker discovery and development. Despite this critical role, cell-based assays have not been standardized and made compliant with Good Laboratory Practice guidelines. In this book, the editors have collected assays for which validation procedures have been developed, making this a vital purchase for anyone using such assays in drug development. This book: Describes the development, optimization and validation of cell-based assays, including procedural documentation required for Good Laboratory Practice Presents validations of cell-based assays for select targets, with step-by-step instructions, allowing the reader to reproduce the assay conditions and results Provides details of techniques used in the evaluation of immunodeficiency, autoimmune and oncological disorders, including assessment of cancer vaccines Offers a compendium of validation parameters that need to be considered when using these methods to develop a new drug Includes detailed protocols for the evaluation of cytokines and of neutralizing antibodies directed against protein therapeutics Validation of Cell-based Assays in the GLP Setting provides the professional with an invaluable reference source, featuring key guidelines. The book will prove extremely useful to all scientists working in the areas of drug development.

Vaccinology

Author : W. John W. Morrow
Publisher : John Wiley & Sons
ISBN 13 : 1118345347
Total Pages : 552 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Vaccinology by : W. John W. Morrow

Download or read book Vaccinology written by W. John W. Morrow and published by John Wiley & Sons. This book was released on 2012-06-12 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covering all aspects of vaccine research and development in one volume, this authoritative resource takes a comprehensive and systematic approach to the science of vaccinology focusing not only on basic science, but also on the many stages required to commercialize and navigate the regulatory requirements for human application, both in the United States and Europe. Reviews in detail the process of designing a vaccine, from the initial stages of antigen discovery to human application Includes evaluation of vaccine efficacy and safety Details clinical trial design, including regulatory requirements Discusses the emerging field of active cellular immunotherapy Vaccinology: Principles and Practice provides an invaluable resource for clinicians, scientific and medical researchers, lecturers and postdoctoral fellows working in the field of vaccines.

Pharmaceutical Biotechnology

Author : Oliver Kayser
Publisher : John Wiley & Sons
ISBN 13 : 352765125X
Total Pages : 677 pages
Book Rating : 4.5/5 (276 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 2012-03-27 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.

Assay Development

Author : Ge Wu
Publisher : John Wiley & Sons
ISBN 13 : 0470583118
Total Pages : 452 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Assay Development by : Ge Wu

Download or read book Assay Development written by Ge Wu and published by John Wiley & Sons. This book was released on 2010-06-25 with total page 452 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Flow Cytometry in Drug Discovery and Development

Author : Virginia Litwin
Publisher : John Wiley & Sons
ISBN 13 : 0470922788
Total Pages : 404 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Flow Cytometry in Drug Discovery and Development by : Virginia Litwin

Download or read book Flow Cytometry in Drug Discovery and Development written by Virginia Litwin and published by John Wiley & Sons. This book was released on 2011-04-20 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.

Drug Development for Gene Therapy

Author : Yanmei Lu
Publisher : John Wiley & Sons
ISBN 13 : 1119852781
Total Pages : 500 pages
Book Rating : 4.1/5 (198 download)

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Book Synopsis Drug Development for Gene Therapy by : Yanmei Lu

Download or read book Drug Development for Gene Therapy written by Yanmei Lu and published by John Wiley & Sons. This book was released on 2024-02-28 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug Development for Gene Therapy Industry-centric perspective on translational and bioanalytical challenges and best practices for gene therapies Drug Development for Gene Therapy focuses on the translational and bioanalytical challenges and best practices for gene therapy modalities, presenting a significant body of data, including information related to safety and efficacy, necessary to advance through the development pipeline into clinical use. The text covers bioanalytical methods and platforms including patient screening assays, different PCR tests, enzyme activity assays, ELISpot, NGS, LC/MS, and immunoassays, with FDA and EMA guidelines on gene therapy safety and efficacy, along with companion diagnostics regulations from US and EU perspectives. The chapters offer an in-depth discussion of the basics and best practices for translational biomarkers, bioanalysis, and developing companion diagnostics / lab tests for gene therapies in the pharma and biopharma industries. To aid in reader comprehension, the text includes clinical examples of relevant therapies in related chapters. Some of the core topics covered include study design, immunogenicity, various bioanalytical methods and their applications, and global regulatory issues. Written by two highly qualified authors with significant experience in the field, Drug Development for Gene Therapy includes information on: Bioanalytical methods to detect pre-existing antibodies against adeno-associated viruses (AAV) capsids Detection of cellular immunity and humoral response to viral capsids and transgene proteins, and immunogenicity of gene therapy products Nonclinical and clinical study considerations and methods for biodistribution and shedding Quantification of transgene protein expression and biochemical function, and substrate and distal pharmacodynamic biomarker measurements for gene therapy Detection and quantification of rAAV integration and off-target editing Current regulatory landscape for gene therapy product development and the role of biomarkers and general regulatory considerations for gene therapy companion diagnostics With comprehensive coverage of the subject, Drug Development for Gene Therapy is a must-have resource for researchers and developers in the areas of pharmaceuticals, biopharmaceuticals, and contract research organizations (CROs), along with professors, researchers, and advanced students in chemistry, biological, biomedical engineering, pharmaceuticals, and medical sciences.

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.

Handbook of ELISPOT

Author : Alexander E. Kalyuzhny
Publisher : Springer Nature
ISBN 13 : 1071636901
Total Pages : 321 pages
Book Rating : 4.0/5 (716 download)

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Book Synopsis Handbook of ELISPOT by : Alexander E. Kalyuzhny

Download or read book Handbook of ELISPOT written by Alexander E. Kalyuzhny and published by Springer Nature. This book was released on with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt:

A Year in Review: Discussions in Immunological Memory

Author : Scott N. Mueller
Publisher : Frontiers Media SA
ISBN 13 : 2832507816
Total Pages : 138 pages
Book Rating : 4.8/5 (325 download)

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Book Synopsis A Year in Review: Discussions in Immunological Memory by : Scott N. Mueller

Download or read book A Year in Review: Discussions in Immunological Memory written by Scott N. Mueller and published by Frontiers Media SA. This book was released on 2022-11-30 with total page 138 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Principles of Safety Pharmacology

Author : Michael K. Pugsley
Publisher : Springer
ISBN 13 : 366246943X
Total Pages : 477 pages
Book Rating : 4.6/5 (624 download)

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Book Synopsis Principles of Safety Pharmacology by : Michael K. Pugsley

Download or read book Principles of Safety Pharmacology written by Michael K. Pugsley and published by Springer. This book was released on 2015-06-19 with total page 477 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book illustrates, in a comprehensive manner, the most current areas of importance to Safety Pharmacology, a burgeoning unique pharmacological discipline with important ties to academia, industry and regulatory authorities. It provides readers with a definitive collection of topics containing essential information on the latest industry guidelines and overviews current and breakthrough topics in both functional and molecular pharmacology. An additional novelty of the book is that it constitutes academic, pharmaceutical and biotechnology perspectives for Safety Pharmacology issues. Each chapter is written by an expert in the area and includes not only a fundamental background regarding the topic but also detailed descriptions of currently accepted, validated models and methods as well as innovative methodologies used in drug discovery.

Protein Therapeutics, 2 Volume Set

Author : Tristan Vaughan
Publisher : John Wiley & Sons
ISBN 13 : 3527340866
Total Pages : 762 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Protein Therapeutics, 2 Volume Set by : Tristan Vaughan

Download or read book Protein Therapeutics, 2 Volume Set written by Tristan Vaughan and published by John Wiley & Sons. This book was released on 2017-12-04 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.

Book Review Index - 2009 Cumulation

Author : Dana Ferguson
Publisher : Book Review Index Cumulation
ISBN 13 : 9781414419121
Total Pages : 1304 pages
Book Rating : 4.4/5 (191 download)

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Book Synopsis Book Review Index - 2009 Cumulation by : Dana Ferguson

Download or read book Book Review Index - 2009 Cumulation written by Dana Ferguson and published by Book Review Index Cumulation. This book was released on 2009-08 with total page 1304 pages. Available in PDF, EPUB and Kindle. Book excerpt: Book Review Index provides quick access to reviews of books, periodicals, books on tape and electronic media representing a wide range of popular, academic and professional interests. The up-to-date coverage, wide scope and inclusion of citations for both newly published and older materials make Book Review Index an exceptionally useful reference tool. More than 600 publications are indexed, including journals and national general interest publications and newspapers. Book Review Index is available in a three-issue subscription covering the current year or as an annual cumulation covering the past year.

Early Drug Development

Author : Mitchell N. Cayen
Publisher : John Wiley & Sons
ISBN 13 : 1118035208
Total Pages : 507 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Early Drug Development by : Mitchell N. Cayen

Download or read book Early Drug Development written by Mitchell N. Cayen and published by John Wiley & Sons. This book was released on 2011-02-25 with total page 507 pages. Available in PDF, EPUB and Kindle. Book excerpt: The focus of early drug development has been the submission of an Investigational New Drug application to regulatory agencies. Early Drug Development: Strategies and Routes to First-in-Human Trials guides drug development organizations in preparing and submitting an Investigational New Drug (IND) application. By explaining the nuts and bolts of preclinical development activities and their interplay in effectively identifying successful clinical candidates, the book helps pharmaceutical scientists determine what types of discovery and preclinical research studies are needed in order to support a submission to regulatory agencies.

Evidence Based Validation of Traditional Medicines

Author : Subhash C. Mandal
Publisher : Springer Nature
ISBN 13 : 9811581274
Total Pages : 1135 pages
Book Rating : 4.8/5 (115 download)

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Book Synopsis Evidence Based Validation of Traditional Medicines by : Subhash C. Mandal

Download or read book Evidence Based Validation of Traditional Medicines written by Subhash C. Mandal and published by Springer Nature. This book was released on 2021-01-18 with total page 1135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The demand for traditional medicines, herbal health products, herbal pharmaceuticals, nutraceuticals, food supplements and herbal cosmetics etc. is increasing globally due to the growing recognition of these products as mainly non-toxic, having lesser side effects, better compatibility with physiological flora, and availability at affordable prices. In the last century, medical science has made incredible advances all over the globe. In spite of global reorganization and a very sound history of traditional uses, the promotion of traditional medicine faces a number of challenges around the globe, primarily in developed nations. Regulation and safety is the high concern for the promotion of traditional medicine. Quality issues and quality control, pharmacogivilane, scientific investigation and validation, intellectual property rights, and biopiracy are some key issues that restrain the advancement of traditional medicine around the globe. This book contains diverse and unique chapters, explaining in detail various subsections like phytomolecule, drug discovery and modern techniques, standardization and validation of traditional medicine, and medicinal plants, safety and regulatory issue of traditional medicine, pharmaceutical excipients from nature, plants for future. The contents of the book will be useful for the academicians, researchers and people working in the area of traditional medicine.

Alternatives to Animal Testing

Author : Christoph A. Reinhardt
Publisher : John Wiley & Sons
ISBN 13 : 3527616047
Total Pages : 200 pages
Book Rating : 4.5/5 (276 download)

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Book Synopsis Alternatives to Animal Testing by : Christoph A. Reinhardt

Download or read book Alternatives to Animal Testing written by Christoph A. Reinhardt and published by John Wiley & Sons. This book was released on 2008-11-20 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Opinion leaders in science and politics examine findings and legislation in alternatives to animal testing! Refine, reduce, replace - These are the three demands that scientists have placed upon themselves in their search for alternatives to animal testing. Indeed much interdisciplinary research is being carried on today, and new fields have emerged, such as in-vitro toxicology. The three R's call for new scientific insights. Moreover, validation and acceptance strategies have to be adapted, a process of much ongoing interest and vital concern to the pharmaceutical and cosmetic industries. Researchers need to know exactly what has been achieved and accepted in alternatives to animal testing in science and politics. In this book they have the opportunity to benefit from the knowledge and expertise of leading researchers and influential representatives of national and international regulatory authorities.

Guideline for Submitting Samples and Analytical Data for Methods Validation

Author :
Publisher :
ISBN 13 :
Total Pages : 28 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Guideline for Submitting Samples and Analytical Data for Methods Validation by :

Download or read book Guideline for Submitting Samples and Analytical Data for Methods Validation written by and published by . This book was released on 1987 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Handbook of Biomarkers and Precision Medicine

Author : Claudio Carini
Publisher : CRC Press
ISBN 13 : 0429576730
Total Pages : 659 pages
Book Rating : 4.4/5 (295 download)

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Book Synopsis Handbook of Biomarkers and Precision Medicine by : Claudio Carini

Download or read book Handbook of Biomarkers and Precision Medicine written by Claudio Carini and published by CRC Press. This book was released on 2019-04-16 with total page 659 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The field of Biomarkers and Precision Medicine in drug development is rapidly evolving and this book presents a snapshot of exciting new approaches. By presenting a wide range of biomarker applications, discussed by knowledgeable and experienced scientists, readers will develop an appreciation of the scope and breadth of biomarker knowledge and find examples that will help them in their own work." -Maria Freire, Foundation for the National Institutes of Health Handbook of Biomarkers and Precision Medicine provides comprehensive insights into biomarker discovery and development which has driven the new era of Precision Medicine. A wide variety of renowned experts from government, academia, teaching hospitals, biotechnology and pharmaceutical companies share best practices, examples and exciting new developments. The handbook aims to provide in-depth knowledge to research scientists, students and decision makers engaged in Biomarker and Precision Medicine-centric drug development. Features: Detailed insights into biomarker discovery, validation and diagnostic development with implementation strategies Lessons-learned from successful Precision Medicine case studies A variety of exciting and emerging biomarker technologies The next frontiers and future challenges of biomarkers in Precision Medicine Claudio Carini, Mark Fidock and Alain van Gool are internationally recognized as scientific leaders in Biomarkers and Precision Medicine. They have worked for decades in academia and pharmaceutical industry in EU, USA and Asia. Currently, Dr. Carini is Honorary Faculty at Kings’s College School of Medicine, London, UK. Dr. Fidock is Vice President of Precision Medicine Laboratories at AstraZeneca, Cambridge, UK. Prof.dr. van Gool is Head Translational Metabolic Laboratory at Radboud university medical school, Nijmegen, NL.