Skip to main content

Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals

In Order to Read Online or Download Nonclinical Assessment Of Abuse Potential For New Pharmaceuticals Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals

Nonclinical Assessment of Abuse Potential for New Pharmaceuticals Book
Author : Carrie Markgraf,Thomas Hudzik,David Compton
Publisher : Academic Press
Release : 2015-07-14
ISBN : 0124202160
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

A Comprehensive Guide to Toxicology in Nonclinical Drug Development

A Comprehensive Guide to Toxicology in Nonclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2016-11-03
ISBN : 0128036214
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 international regulatory guidelines, this second edition is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides unique content that is not always covered together in one comprehensive resource, including chapters on stem cells, abuse liability, biomarkers, inhalation toxicology, biostatistics, and more Updated with 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 the expectations associated with working in nonclinical toxicology

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development Book
Author : Ali S. Faqi
Publisher : Academic Press
Release : 2012-10-18
ISBN : 0123878160
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Stem Cells in Toxicology and Medicine Book
Author : Saura C. Sahu
Publisher : John Wiley & Sons
Release : 2016-10-13
ISBN : 1119135427
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Substance Use Disorders

Substance Use Disorders Book
Author : F. Gerard Moeller,Mishka Terplan
Publisher : Oxford University Press, USA
Release : 2020-10
ISBN : 019092019X
Language : En, Es, Fr & De

GET BOOK

Book Description :

"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

The Nonhuman Primate in Nonclinical Drug Development and Safety Assessment Book
Author : Joerg Bluemel,Sven Korte,Emanuel Schenck,Gerhard Weinbauer
Publisher : Academic Press
Release : 2015-03-13
ISBN : 012417146X
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Drug Discovery and Development  Third Edition Book
Author : James J. O'Donnell,John Somberg,Vincent Idemyor,James T. O'Donnell
Publisher : CRC Press
Release : 2019-11-21
ISBN : 1351625144
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

The SAGE Encyclopedia of Pharmacology and Society

The SAGE Encyclopedia of Pharmacology and Society Book
Author : Sarah E. Boslaugh
Publisher : SAGE Publications
Release : 2015-09-15
ISBN : 1506346189
Language : En, Es, Fr & De

GET BOOK

Book Description :

The SAGE Encyclopedia of Pharmacology and Society explores the social and policy sides of the pharmaceutical industry and its pervasive influence in society. While many technical STM works explore the chemistry and biology of pharmacology and an equally large number of clinically oriented works focus on use of illegal drugs, substance abuse, and treatment, there is virtually nothing on the immensely huge business (“Big Pharma”) of creating, selling, consuming, and regulating legal drugs. With this new Encyclopedia, the topic of socioeconomic, business and consumer, and legal and ethical issues of the pharmaceutical industry in contemporary society around the world are addressed. Key Features: 800 signed articles, authored by prominent scholars, are arranged A-to-Z and published in a choice of electronic or print formats Although arranged A-to-Z, a Reader's Guide in the front matter groups articles by thematic areas Front matter also includes a Chronology highlighting significant developments in this field All articles conclude with Further Readings and Cross References to related articles Back matter includes an annotated Resource Guide to further research, a Glossary, Appendices (e.g., statistics on the amount and types of drugs prescribed, etc.), and a detailed Index The Index, Reader’s Guide, and Cross References combine for search-and-browse capabilities in the electronic edition The SAGE Encyclopedia of Pharmacology and Society is an authoritative and rigorous source addressing the pharmacology industry and how it influences society, making it a must-have reference for all academic libraries as a source for both students and researchers to utilize.

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology Book
Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Release : 2018-09-05
ISBN : 0128123346
Language : En, Es, Fr & De

GET BOOK

Book Description :

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. Focuses on pharmacology issues that result during drug development and provides de-risking techniques and practical advice Covers a broad selection of topics, including specialized animal models, PBPK modeling, the use of high frequency EEG in problem-solving, drug-induced self-injury, abuse potential liability, biomarkers, imaging, and much more Focuses on the resolution of these issues in order to better address regulatory expectancies and develop safer, more effective drugs

Drug Discovery Toxicology

Drug Discovery Toxicology Book
Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Publisher : John Wiley & Sons
Release : 2016-04-18
ISBN : 1119053331
Language : En, Es, Fr & De

GET BOOK

Book Description :

As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices

Testing for Abuse Liability of Drugs in Humans

Testing for Abuse Liability of Drugs in Humans Book
Author : Marian W. Fischman,Nancy K. Mello
Publisher : Unknown
Release : 1989
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Representatives from industry, academia and government discuss issues related to testing for drug abuse liability and dependence potential. Contributors critically assess current methods for evaluating drugs in human subjects and describe both the advantages and limitations of each approach. This information permits identification of areas in which further research and development are needed.

Animal and Translational Models for CNS Drug Discovery Reward Deficit Disorders

Animal and Translational Models for CNS Drug Discovery  Reward Deficit Disorders Book
Author : Robert A. McArthur,Franco Borsini
Publisher : Academic Press
Release : 2009-02-24
ISBN : 0080920403
Language : En, Es, Fr & De

GET BOOK

Book Description :

Reward Deficit Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for reward deficit disorders such as alcohol dependence, nicotine dependence, heroin and cocaine addiction, obesity, and gambling and impulse control disorders. Reward Deficit Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. Reward Deficit Disorders also has a section dedicated to the specifics of the regulatory aspects to abuse liability testing. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the third volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Provides clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasizes what results mean to the overall drug discovery process Explores issues in clinical trial design and conductance in each therapeutic area Neurological Disorders is available for purchase individually.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies Book
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release : 2014-05-02
ISBN : 1118874080
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

NIDA Research Monograph

NIDA Research Monograph Book
Author : Anonim
Publisher : Unknown
Release : 1976
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

Download NIDA Research Monograph book written by , available in PDF, EPUB, and Kindle, or read full book online anywhere and anytime. Compatible with any devices.

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries Book
Author : Lanju Zhang
Publisher : Springer
Release : 2016-01-13
ISBN : 3319235583
Language : En, Es, Fr & De

GET BOOK

Book Description :

This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

Methods of Assessing the Reinforcing Properties of Abused Drugs

Methods of Assessing the Reinforcing Properties of Abused Drugs Book
Author : Michael A. Bozarth
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 1461248124
Language : En, Es, Fr & De

GET BOOK

Book Description :

Methods of Assessing the Reinforcing Properties of Abused Drugs presents a synopsis of the preclinical procedures used to assess drug reinforcement. Researchers using one technique are provided with an overview of the other available methods, and clinicians who wish to evaluate drug abuse research reports can gain the necessary background from this volume. Although emphasis is placed on the methodological aspects of assessing drug reinforcement, some of the scientific conclusions derived from using these techniques are also presented. This edited collection offers a lasting framework for interpreting the results of current experimental findings.

Technologies for Understanding and Preventing Substance Abuse and Addiction

Technologies for Understanding and Preventing Substance Abuse and Addiction Book
Author : DIANE Publishing Company
Publisher : DIANE Publishing
Release : 1996-04
ISBN : 9780788127861
Language : En, Es, Fr & De

GET BOOK

Book Description :

Focuses on several factors that are necessary for substance abuse & addiction to occur, including an examination of the biological research regarding the phenomenon of addiction to a variety of substances. Describes individual risk & protection factors that contribute to the abuse, & addiction to alcohol & drugs. Looks at how risk & protection factors play out in subcultures & in major activity settings including the home, school, workplace & recreation settings. Addresses a range of legislative options for Congress. History of drug control policy in the U.S.

Early Drug Development

Early Drug Development Book
Author : Fabrizio Giordanetto
Publisher : John Wiley & Sons
Release : 2018-06-15
ISBN : 3527801774
Language : En, Es, Fr & De

GET BOOK

Book Description :

This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.

Veterinary Toxicology

Veterinary Toxicology Book
Author : Ramesh C. Gupta
Publisher : Academic Press
Release : 2012-04-23
ISBN : 0123859271
Language : En, Es, Fr & De

GET BOOK

Book Description :

Veterinary Toxicology, 2nd Edition, is a unique single reference that teaches the basic principles of veterinary toxicology and builds upon these principles to offer an essential clinical resource for those practicing in the field. This new edition brings together insights from qualified and well-experienced authorities across all areas of veterinary toxicology to provide an authoritative and in-depth look at all facets of veterinary toxicology, including target organ toxicity, melamine and cyanuric acid, toxicogenomics, chemical terrorism and nanoparticles. While most comparable texts are primarily directed toward the field of human toxicology, this is the one text needed to thoroughly prepare future veterinarians on the newest approaches for diagnosing poisoning cases in all animals from chemicals and plants of a diverse nature as a result of inadvertent, accidental, or malicious intents. It is thoroughly updated with new chapters and the latest coverage of topics not tackled in any previous books such as target organ toxicity, radiation and radioactive materials, FDA regulatory issues, and ethics in veterinary toxicology. There are also expanded discussions on international topics such as epidemiology of animal poisonings and regulatory guidelines and poisonous plants in Europe. Problem solving strategies are offered for treatment. This volume will be of interest to practitioners, professors and students of veterinary medicine and veterinary toxicology, poison control centers, marine biologists, environmentalists and animal scientists. Selected for inclusion in Doody's Core Titles 2013, an essential collection development tool for health sciences libraries New chapters covering important and timely topics such as melamine and cyanuric acid, toxicogenomics, toxic gases and veterinary medical geology Expanded look at international topics, such as epidemiology of animal poisonings, regulatory guidelines and poisonous plants in Europe Heavily contributed book with chapters written by qualified and well-experienced authorities across all areas of veterinary toxicology Problem solving strategies are offered for treatment as well as in-depth knowledge of the basic mechanisms of veterinary toxicology

Drug Safety Data

Drug Safety Data Book
Author : Michael J. Klepper,Barton Cobert
Publisher : Jones & Bartlett Learning
Release : 2010-10-25
ISBN : 9780763769123
Language : En, Es, Fr & De

GET BOOK

Book Description :

Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk was selected for The First Clinical Research Bookshelf - Essential reading for clinical research professionals by the Journal of Clinical Research Best Practices. Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk provides drug safety/pharmacovogilance professionals, pharmaceutical and clinical research scientists, statisticians, programmers, medical writers, and technicians with an accessible, practical framework for the analysis, summary and interpretation of drug safety data. The only guide of its kind, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is an invaluable reference for pre- and post-marketing risk assessment. With decades of pharmaceutical research and drug safety expertise, authors Dr. Klepper and Dr. Cobert discuss how quality planning, safety training, and data standardization result in significant cost, time, and resource savings. Through illustrative, step-by-step instruction, Drug Safety Data: How to Analyze, Summarize and Interpret to Determine Risk is the definitive guide to drug safety data analysis and reporting. Key features include: * Step-by-step instruction on how to analyze, summarize and interpret safety data for mandatory governmental safety reports * Pragmatic tips...and mistakes to avoid * Simple explanations of what safety data are collected, and what the data mean * Practical approaches to determining a drug effect and understanding its clinical significance * Guidance for determining risk throughout the lifecycle of a drug, biologic or nutraceutical * Examples of user-friendly data displays that enhance safety signal identification * Ways to improve data quality and reduce the time, resources and costs involved in mandatory safety reporting * Relevant material for the required training of drug safety/pharmacovigilance professionals * SPECIAL FEATURE: Actual examples of an Integrated Analysis of Safety (IAS) -used in the preparation of the Integrated Summary of Safety (ISS) and the Summary of Clinical Safety (SCS) reports -, and the Periodic Safety Update Report (PSUR)