Preclinical Development Handbook
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Preclinical Development Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-21
Preclinical Development Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-21 with Medical categories.
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic,comprehensive reference to prioritizing and optimizing leads, toxicity, pharmacogenomics, modeling, and regulations. This single definitive, easy-to-use resource discusses all the issues that need consideration and provides detailed instructions for current methods and techniques. Each chapter was written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor, with more than thirty years' experience working with pharmaceutical and biotechnology companies, carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * In vitro mammalian cytogenetics tests * Phototoxicity * Carcinogenicity studies * The pharmacogenomics of personalized medicine * Bridging studies * Toxicogenomics and toxicoproteomics Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This is a hands-on guide for pharmaceutical scientists involved in preclinical testing,enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
A Comprehensive Guide To Toxicology In Preclinical Drug Development
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Author : Ali S. Faqi
language : en
Publisher: Academic Press
Release Date : 2012-10-18
A Comprehensive Guide To Toxicology In Preclinical Drug Development written by Ali S. Faqi and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-18 with Medical categories.
A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. - Chapters written by world-renowned contributors who are experts in their fields - Includes the latest research in preclinical drug testing and international guidelines - Covers preclinical toxicology in small molecules and biologics in one single source
Preclinical Development Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-21
Preclinical Development Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-21 with Medical categories.
A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
A Practical Guide To Drug Development In Academia
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Author : Daria Mochly-Rosen
language : en
Publisher: Springer Science & Business Media
Release Date : 2014-07-08
A Practical Guide To Drug Development In Academia written by Daria Mochly-Rosen and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-07-08 with Medical categories.
"A lot of hard-won knowledge is laid out here in a brief but informative way. Every topic is well referenced, with citations from both the primary literature and relevant resources from the internet." Review from Nature Chemical Biology Written by the founders of the SPARK program at Stanford University, this book is a practical guide designed for professors, students and clinicians at academic research institutions who are interested in learning more about the drug development process and how to help their discoveries become the novel drugs of the future. Often many potentially transformative basic science discoveries are not pursued because they are deemed ‘too early’ to attract industry interest. There are simple, relatively cost-effective things that academic researchers can do to advance their findings to the point that they can be tested in the clinic or attract more industry interest. Each chapter broadly discusses an important topic in drug development, from preclinical work in assay design through clinical trial design, regulatory issues and marketing assessments. After the practical overview provided here, the reader is encouraged to consult more detailed texts on specific topics of interest. "I would actually welcome it if this book’s intended audience were broadened even more. Younger scientists starting out in the drug industry would benefit from reading it and getting some early exposure to parts of the process that they’ll eventually have to understand. Journalists covering the industry (especially the small startup companies) will find this book a good reality check for many an over-hopeful press release. Even advanced investors who might want to know what really happens in the labs will find information here that might otherwise be difficult to track down in such a concentrated form."
Biomarkers In Drug Development
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Author : Michael R. Bleavins
language : en
Publisher: John Wiley & Sons
Release Date : 2011-09-20
Biomarkers In Drug Development written by Michael R. Bleavins and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-09-20 with Medical categories.
Discover how biomarkers can boost the success rate of drug development efforts As pharmaceutical companies struggle to improve the success rate and cost-effectiveness of the drug development process, biomarkers have emerged as a valuable tool. This book synthesizes and reviews the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. Filled with case studies, the book demonstrates how biomarkers can improve drug development timelines, lower costs, facilitate better compound selection, reduce late-stage attrition, and open the door to personalized medicine. Biomarkers in Drug Development is divided into eight parts: Part One offers an overview of biomarkers and their role in drug development. Part Two highlights important technologies to help researchers identify new biomarkers. Part Three examines the characterization and validation process for both drugs and diagnostics, and provides practical advice on appropriate statistical methods to ensure that biomarkers fulfill their intended purpose. Parts Four through Six examine the application of biomarkers in discovery, preclinical safety assessment, clinical trials, and translational medicine. Part Seven focuses on lessons learned and the practical aspects of implementing biomarkers in drug development programs. Part Eight explores future trends and issues, including data integration, personalized medicine, and ethical concerns. Each of the thirty-eight chapters was contributed by one or more leading experts, including scientists from biotechnology and pharmaceutical firms, academia, and the U.S. Food and Drug Administration. Their contributions offer pharmaceutical and clinical researchers the most up-to-date understanding of the strategies used for and applications of biomarkers in drug development.
Preclinical Development Handbook 2 Volume Set
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Author : Shayne Cox Gad
language : en
Publisher: Wiley-Interscience
Release Date : 2008-03-14
Preclinical Development Handbook 2 Volume Set written by Shayne Cox Gad and has been published by Wiley-Interscience this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-14 with Medical categories.
This book brings together in one resource an overview of the preclinical process along with a compendium of methods and techniques that need to be considered when developing a new drug. The book details steps in the preclinical process including: prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, toxicity, modeling, and regulations. It includes problems that are encountered, solutions to these problems, and limitations of various methods and techniques used in determining the safety and efficacy of a drug at this stage.
Early Drug Development
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Author : Mitchell N. Cayen
language : en
Publisher: John Wiley & Sons
Release Date : 2011-02-25
Early Drug Development written by Mitchell N. Cayen and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-02-25 with Medical categories.
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.
Good Research Practice In Non Clinical Pharmacology And Biomedicine
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Author : Anton Bespalov
language : en
Publisher: Springer Nature
Release Date : 2020-02-20
Good Research Practice In Non Clinical Pharmacology And Biomedicine written by Anton Bespalov and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-02-20 with Medical categories.
This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Clinical Trials Handbook
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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2009-06-17
Clinical Trials Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-06-17 with Science categories.
Best practices for conducting effective and safe clinical trials Clinical trials are arguably the most important steps in proving drug effectiveness and safety for public use. They require intensive planning and organization and involve a wide range of disciplines: data management, biostatistics, pharmacology, toxicology, modeling and simulation, regulatory monitoring, ethics, and particular issues for given disease areas. Clinical Trials Handbook provides a comprehensive and thorough reference on the basics and practices of clinical trials. With contributions from a range of international authors, the book takes the reader through each trial phase, technique, and issue. Chapters cover every key aspect of preparing and conducting clinical trials, including: Interdisciplinary topics that have to be coordinated for a successful clinical trialData management (and adverse event reporting systems) Biostatistics, pharmacology, and toxicology Modeling and simulation Regulatory monitoring and ethics Particular issues for given disease areas-cardiology, oncology, cognitive, dementia, dermatology, neuroscience, and more With unique information on such current issues as adverse event reporting (AER) systems, adaptive trial designs, and crossover trial designs, Clinical Trials Handbook will be a ready reference for pharmaceutical scientists, statisticians, researchers, and the many other professionals involved in drug development.
Handbook Of Anticancer Drug Development
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Author : Daniel Budman
language : en
Publisher: Lippincott Raven
Release Date : 2003
Handbook Of Anticancer Drug Development written by Daniel Budman and has been published by Lippincott Raven this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003 with Medical categories.
Perhaps no area of pharmacology has progressed further or faster than that of anticancer drugs. With this concise and informative resource, you'll explore the full spectrum of anticancer drug evolution -- from research and development, through clinical trials, to licensure and utilization.