Hands On Approach for the Conduct of Nonclinical Studies

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  • Publisher : Academic Press
  • Release : 01 March 2019
  • ISBN : 0128131004
  • Page : 365 pages
  • Rating : 4.5/5 from 103 voters

Hands On Approach for the Conduct of Nonclinical Studies Book PDF summary

Hands-on Approach for the Conduct of Nonclinical Studies: A Manual for Anticipating and Avoiding Potential Problems focuses on practical approaches to real-life challenges faced during nonclinical studies, providing insights into the anticipation of potential problems and solutions to problems which may arise, saving time, money and resources. The book outlines Good Laboratory Practice in detail and includes regulatory guidelines, communication, stakeholder information and case studies. It is essential reading for study directors/technical coordinators, quality assurance personnel, all technical staff and project managers. In addition, it offers guidance for those new to the area, while also acting as a reference for senior researchers. Includes an introduction to Good Laboratory Practice (GLP) scenarios and the related regulations Explains aspects of study directorship, including documentation, document review, implementation and execution of preclinical studies Provides a detailed account of the responsibilities of each stakeholder (technical, managerial, sponsor) within the study and how timely they need to act to seamlessly move a project

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Hands-On Approach for the Conduct of Nonclinical Studies

Hands-On Approach for the Conduct of Nonclinical Studies
  • Author : Deven Dandekar,Pallavi B. Limaye
  • Publisher : Academic Press
  • Release Date : 2019-03
  • ISBN : 0128131004
DOWNLOAD BOOKHands-On Approach for the Conduct of Nonclinical Studies

Hands-on Approach for the Conduct of Nonclinical Studies: A Manual for Anticipating and Avoiding Potential Problems focuses on practical approaches to real-life challenges faced during nonclinical studies, providing insights into the anticipation of potential problems and solutions to problems which may arise, saving time, money and resources. The book outlines Good Laboratory Practice in detail and includes regulatory guidelines, communication, stakeholder information and case studies. It is essential reading for study directors/technical coordinators, quality assurance personnel, all technical staff

Targeted Therapy in Translational Cancer Research

Targeted Therapy in Translational Cancer Research
  • Author : Apostolia-Maria Tsimberidou,Razelle Kurzrock,Kenneth C. Anderson
  • Publisher : John Wiley & Sons
  • Release Date : 2015-10-08
  • ISBN : 9781118468685
DOWNLOAD BOOKTargeted Therapy in Translational Cancer Research

Targeted Therapy in Translational Cancer Research for the Translational Oncology series provides a comprehensive overview of recent developments in our understanding of tumor biology, elucidates the roles of targets and pathways involved in carcinogenesis, and describes current state-of-the-art anticancer therapy, as well as the most promising areas of translational research and targeted therapy. Introduces cutting-edge ‘bench to bedside and back’ breakthroughs which have transformed the diagnosis, prognosis, and treatment of cancer Covers basic principles of targeted therapy, including immunotherapy and

Pharmaceutical Toxicology in Practice

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  • Author : Alberto Lodola,Jeanne Stadler
  • Publisher : John Wiley & Sons
  • Release Date : 2011-03-31
  • ISBN : 9780470922729
DOWNLOAD BOOKPharmaceutical Toxicology in Practice

This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with

Translational Medicine

Translational Medicine
  • Author : Joy A. Cavagnaro,Mary Ellen Cosenza
  • Publisher : CRC Press
  • Release Date : 2021-11-26
  • ISBN : 9781000471823
DOWNLOAD BOOKTranslational Medicine

Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
  • Author : William J. Brock,Barbara Mounho,Lijie Fu
  • Publisher : John Wiley & Sons
  • Release Date : 2014-06-03
  • ISBN : 9781118370391
DOWNLOAD BOOKThe Role of the Study Director in Nonclinical Studies

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal

Nonclinical Safety Assessment

Nonclinical Safety Assessment
  • Author : William J. Brock,Kenneth L. Hastings,Kathy M. McGown
  • Publisher : John Wiley & Sons
  • Release Date : 2013-03-05
  • ISBN : 9781118516980
DOWNLOAD BOOKNonclinical Safety Assessment

Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to

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  • Author : Jan Willem van der Laan,Joseph J DeGeorge
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-02-11
  • ISBN : 9781461459507
DOWNLOAD BOOKGlobal Approach in Safety Testing

This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
  • Author : William J. Brock,Barbara Mounho,Lijie Fu
  • Publisher : John Wiley & Sons
  • Release Date : 2014-05-02
  • ISBN : 9781118874080
DOWNLOAD BOOKThe Role of the Study Director in Nonclinical Studies

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal

Handbook of Bioequivalence Testing

Handbook of Bioequivalence Testing
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2014-10-29
  • ISBN : 9781482226386
DOWNLOAD BOOKHandbook of Bioequivalence Testing

As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

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  • Author : Anton Nijholt,Jose Luis Contreras-Vidal,Camille Jeunet,Aleksander Väljamäe
  • Publisher : Frontiers Media SA
  • Release Date : 2022-03-17
  • ISBN : 9782889747177
DOWNLOAD BOOKBrain-Computer Interfaces for Non-clinical (Home, Sports, Art, Entertainment, Education, Well-being) Applications

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2016-11-03
  • ISBN : 9780128036211
DOWNLOAD BOOKA Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Second Edition, is a valuable reference designed to provide a complete understanding of all aspects of nonclinical toxicology in the development of small molecules and biologics. This updated edition has been reorganized and expanded to include important topics such as stem cells in nonclinical toxicology, inhalation and dermal toxicology, pitfalls in drug development, biomarkers in toxicology, and more. Thoroughly updated to reflect the latest scientific advances and with increased coverage of

Management of Animal Care and Use Programs in Research, Education, and Testing

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  • Author : Robert H. Weichbrod,Gail A. (Heidbrink) Thompson,John N. Norton
  • Publisher : CRC Press
  • Release Date : 2017-09-07
  • ISBN : 9781498748452
DOWNLOAD BOOKManagement of Animal Care and Use Programs in Research, Education, and Testing

AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all

Good Research Practice in Non-Clinical Pharmacology and Biomedicine

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  • Author : Anton Bespalov,Martin C. Michel,Thomas Steckler
  • Publisher : Springer Nature
  • Release Date : 2020-01-01
  • ISBN : 9783030336561
DOWNLOAD BOOKGood Research Practice in Non-Clinical Pharmacology and Biomedicine

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.

A Comprehensive Guide to Toxicology in Preclinical Drug Development

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  • Author : Ali S. Faqi
  • Publisher : Academic Press
  • Release Date : 2012-11-16
  • ISBN : 9780123878151
DOWNLOAD BOOKA Comprehensive Guide to Toxicology in Preclinical Drug Development

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

Nonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring
  • Author : William F. Salminen,Joe M. Fowler,James Greenhaw
  • Publisher : Academic Press
  • Release Date : 2012-12-31
  • ISBN : 9780123978318
DOWNLOAD BOOKNonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP