Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals
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Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals
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Author : Carrie Markgraf
language : en
Publisher: Academic Press
Release Date : 2015-07-14
Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals written by Carrie Markgraf and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07-14 with Medical categories.
Nonclinical Assessment of Abuse Potential for New Pharmaceuticals offers a complete reference on the current international regulatory guidelines and details best practice methodology for the three standard animal models used to evaluate abuse potential: physical dependence, self-administration and drug discrimination. This book also includes chapters on alternative models and examples of when you should use these alternatives. Case histories are provided at the end of the book to show how the data generated from the animal models play a pivitol role in the submission package for a new drug. By incorporating all of this information into one book, Nonclinical Assessment of Abuse Potential for New Pharmaceuticals is your single resource for everything you need to know to understand and implement the assessment of abuse liability. Provides a consolidated overview of the complex regulatory landscape Offers best practice methodology for conducting animal studies, including selection of doses and positive control agents that will help you improve your own abuse potential studies Includes real-life examples to illustrate how nonclinical data fit into the submission strategy
Principles Of Safety Pharmacology
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Author : Michael K. Pugsley
language : en
Publisher: Springer
Release Date : 2015-06-19
Principles Of Safety Pharmacology written by Michael K. Pugsley and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-06-19 with Medical categories.
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.
Advanced Issue Resolution In Safety Pharmacology
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Author : Mary Jeanne Kallman
language : en
Publisher: Academic Press
Release Date : 2018-09-07
Advanced Issue Resolution In Safety Pharmacology written by Mary Jeanne Kallman and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-09-07 with Medical categories.
Advanced Issue Resolution in Safety Pharmacology not only discusses unique issues that may emerge during the development of new medicines, but also provides detailed insights on how to resolve them. The book employs a valuable strategy that integrates preclinical findings with the clinical resolution of those findings. In addition, it introduces key interdisciplinary topics in an accessible and systematic format. Edited and written by leaders in the field of safety pharmacology, this book considerably advances the discussion on issue resolution topics, thus raising them to the next level of importance by providing scientists with an indispensable resource on solving safety issues.
A Comprehensive Guide To Toxicology In Nonclinical Drug Development
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Author : Ali S. Faqi
language : en
Publisher: Elsevier
Release Date : 2024-02-11
A Comprehensive Guide To Toxicology In Nonclinical Drug Development written by Ali S. Faqi and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-02-11 with Medical categories.
A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
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
Stem Cells In Toxicology And Medicine
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Author : Saura C. Sahu
language : en
Publisher: John Wiley & Sons
Release Date : 2016-10-13
Stem Cells In Toxicology And Medicine written by Saura C. Sahu 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 2016-10-13 with Science categories.
A comprehensive and authoritative compilation of up-to-date developments in stem cell research and its use in toxicology and medicine Presented by internationally recognized investigators in this exciting field of scientific research Provides an insight into the current trends and future directions of research in this rapidly developing new field A valuable and excellent source of authoritative and up-to-date information for researchers, toxicologists, drug industry, risk assessors and regulators in academia, industry and government
Drug Discovery And Evaluation Methods In Clinical Pharmacology
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Author : H.Gerhard Vogel
language : en
Publisher: Springer Science & Business Media
Release Date : 2010-12-15
Drug Discovery And Evaluation Methods In Clinical Pharmacology written by H.Gerhard Vogel 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 2010-12-15 with Medical categories.
Drug Discovery and Evaluation has become a more and more difficult, expensive and time-consuming process. The effect of a new compound has to be detected by in vitro and in vivo methods of pharmacology. The activity spectrum and the potency compared to existing drugs have to be determined. As these processes can be divided up stepwise we have designed a book series "Drug Discovery and Evaluation" in the form of a recommendation document. The methods to detect drug targets are described in the first volume of this series "Pharmacological Assays" comprising classical methods as well as new technologies. Before going to man, the most suitable compound has to be selected by pharmacokinetic studies and experiments in toxicology. These preclinical methods are described in the second volume „Safety and Pharmacokinetic Assays". Only then are first studies in human beings allowed. Special rules are established for Phase I studies. Clinical pharmacokinetics are performed in parallel with human studies on tolerability and therapeutic effects. Special studies according to various populations and different therapeutic indications are necessary. These items are covered in the third volume: „Methods in Clinical Pharmacology".
Substance Use Disorders
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Author : Gerard Moeller
language : en
Publisher: Oxford University Press, USA
Release Date : 2020-10
Substance Use Disorders written by Gerard Moeller and has been published by Oxford University Press, USA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10 with Medical categories.
"Over the last few years there has been an increased interest in identification and treatment of substance use disorders, due at least in part to the widespread drug overdose epidemic. Clinicians and the lay public have gained a greater understanding of the need for treatment of substance use disorders and the consequences of avoiding treatment. In addition, there has been a growing understanding of substance use disorders as medical or mental health disorders, rather than character flaws or merely illegal activities. This book builds on this nascent understanding and presents epidemiology, basic science, and treatment from the perspective of a clinician who wants to gain knowledge and background to work with this patient population. The overall theme of the book is to discuss evidence-based rather than anecdotal or unproven treatments. Section 1 begins with the epidemiology, etiology, and neurobiology of substance use disorders, including preclinical data. Section 2 discusses pharmacotherapy for substance use disorders, focusing on FDA approved medications. Section 3 focuses on other evidence-based treatments for substance use disorders including behavioral therapies and ends with potential future treatments"--
The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment
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Author : Joerg Bluemel
language : en
Publisher: Academic Press
Release Date : 2015-03-13
The Nonhuman Primate In Nonclinical Drug Development And Safety Assessment written by Joerg Bluemel and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-03-13 with Medical categories.
The Nonhuman Primate in Drug Development and Safety Assessment is a valuable reference dedicated to compiling the latest research on nonhuman primate models in nonclinical safety assessment, regulatory toxicity testing and translational science. By covering important topics such as study planning and conduct, inter-species genetic drift, pathophysiology, animal welfare legislation, safety assessment of biologics and small molecules, immunotoxicology and much more, this book provides scientific and technical insights to help you safely and successfully use nonhuman primates in pharmaceutical toxicity testing. A comprehensive yet practical guide, this book is intended for new researchers or practicing toxicologists, toxicologic pathologists and pharmaceutical scientists working with nonhuman primates, as well as graduate students preparing for careers in this area. Covers important topics such as species selection, study design, experimental methodologies, animal welfare and the 3Rs (Replace, Refine and Reduce), social housing, regulatory guidelines, comparative physiology, reproductive biology, genetic polymorphisms and more Includes practical examples on techniques and methods to guide your daily practice Offers a companion website with high-quality color illustrations, reference values for safety assessment and additional practical information such as study design considerations, techniques and procedures and dosing and sampling volumes
Drug Discovery And Development Third Edition
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Author : James J. O'Donnell
language : en
Publisher: CRC Press
Release Date : 2019-11-21
Drug Discovery And Development Third Edition written by James J. O'Donnell and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-21 with Medical categories.
Drug Discovery and Development, Third Edition presents up-to-date scientific information for maximizing the ability of a multidisciplinary research team to discover and bring new drugs to the marketplace. It explores many scientific advances in new drug discovery and development for areas such as screening technologies, biotechnology approaches, and evaluation of efficacy and safety of drug candidates through preclinical testing. This book also greatly expands the focus on the clinical pharmacology, regulatory, and business aspects of bringing new drugs to the market and offers coverage of essential topics for companies involved in drug development. Historical perspectives and predicted trends are also provided. Features: Highlights emerging scientific fields relevant to drug discovery such as the microbiome, nanotechnology, and cancer immunotherapy; and novel research tools such as CRISPR and DNA-encoded libraries Case study detailing the discovery of the anti-cancer drug, lorlatinib Venture capitalist commentary on trends and best practices in drug discovery and development Comprehensive review of regulations and their impact on drug development, highlighting special populations, orphan drugs, and pharmaceutical compounding Multidiscipline functioning of an Academic Research Enterprise, plus a chapter on Ethical Concerns in Research Contributions by 70+ experts from industry and academia specialists who developed and are practitioners of the science and business