Advanced Issue Resolution In Safety Pharmacology

Author : Mary Jeanne Kallman,Michael Pugsley
Publisher : Academic Press
Page : 360 pages
File Size : 41,6 Mb
Release : 2018-09-05
Category : Medical
ISBN : 9780128123348

Get Book

Advanced Issue Resolution in Safety Pharmacology by Mary Jeanne Kallman,Michael Pugsley Pdf

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

Author : Michael K. Pugsley,Michael J Curtis
Publisher : Springer
Page : 481 pages
File Size : 44,7 Mb
Release : 2015-06-19
Category : Medical
ISBN : 9783662469439

Get Book

Principles of Safety Pharmacology by Michael K. Pugsley,Michael J Curtis Pdf

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.

Author : A. Wallace Hayes,Tetyana Kobets
Publisher : CRC Press
Page : 2143 pages
File Size : 41,7 Mb
Release : 2023-07-03
Category : Medical
ISBN : 9781000875775

Get Book

Hayes' Principles and Methods of Toxicology by A. Wallace Hayes,Tetyana Kobets Pdf

Hayes’ Principles and Methods of Toxicology has long been established as a reliable and informative reference for the concepts, methodologies, and assessments integral to toxicology. The new edition contains updated and new chapters with the addition of new authors while maintaining the same high standards that have made this book a benchmark resource in the field. Key Features: The comprehensive yet concise coverage of various aspects of fundamental and applied toxicology makes this book a valuable resource for educators, students, and professionals. Questions provided at the end of each chapter allow readers to test their knowledge and understanding of the material covered. All chapters have been updated and over 60 new authors have been added to reflect the dynamic nature of toxicological sciences New topics in this edition include Safety Assessment of Cosmetics and Personal Care Products, The Importance of the Dose/Rate Response, Novel Approaches and Alternative Models, Epigenetic Toxicology, and an Expanded Glossary. The volume is divided into 4 major sections, addressing fundamental principles of toxicology (Section I. "Principles of Toxicology"), major classes of established chemical hazards (Section II. "Agents"), current methods used for the assessment of various endpoints indicative of chemical toxicity (Section III. "Methods"), as well as toxicology of specific target systems and organs (Section IV. "Organ- and System-Specific Toxicology"). This volume will be a valuable tool for the audience that wishes to broaden their understanding of hazards and mechanisms of toxicity and to stay on top of the emerging methods and concepts of the rapidly advancing field of toxicology and risk assessment.

Author : Anonim
Publisher : John Wiley & Sons
Page : 6057 pages
File Size : 51,6 Mb
Release : 2021-04-20
Category : Science
ISBN : 9781119530305

Get Book

Burger's Medicinal Chemistry, Drug Discovery and Development, 8 Volume Set by Anonim Pdf

Burger’s Medicinal Chemistry, Drug Discovery and Development Explore the freshly updated flagship reference for medicinal chemists and pharmaceutical professionals The newly revised eighth edition of the eight-volume Burger’s Medicinal Chemistry, Drug Discovery and Development is the latest installment in this celebrated series covering the entirety of the drug development and discovery process. With the addition of expert editors in each subject area, this eight-volume set adds 35 chapters to the extensive existing chapters. New additions include analyses of opioid addiction treatments, antibody and gene therapy for cancer, blood-brain barrier, HIV treatments, and industrial-academic collaboration structures. Along with the incorporation of practical material on drug hunting, the set features sections on drug discovery, drug development, cardiovascular diseases, metabolic diseases, immunology, cancer, anti-Infectives, and CNS disorders. The text continues the legacy of previous volumes in the series by providing recognized, renowned, authoritative, and comprehensive information in the area of drug discovery and development while adding cutting-edge new material on issues like the use of artificial intelligence in medicinal chemistry. Included: Volume 1: Methods in Drug Discovery, edited by Kent D. Stewart Volume 2: Discovering Lead Molecules, edited by Kent D. Stewart Volume 3: Drug Development, edited by Ramnarayan S. Randad and Michael Myers Volume 4: Cardiovascular, Endocrine, and Metabolic Diseases, edited by Scott D. Edmondson Volume 5: Pulmonary, Bone, Immunology, Vitamins, and Autocoid Therapeutic Agents, edited by Bryan H. Norman Volume 6: Cancer, edited by Barry Gold and Donna M. Huryn Volume 7: Anti-Infectives, edited by Roland E. Dolle Volume 8: CNS Disorders, edited by Richard A. Glennon Perfect for research departments in the pharmaceutical and biotechnology industries, Burger’s Medicinal Chemistry, Drug Discovery and Development can be used by graduate students seeking a one-stop reference for drug development and discovery and deserves its place in the libraries of biomedical research institutes, medical, pharmaceutical, and veterinary schools.

Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Page : 118 pages
File Size : 52,7 Mb
Release : 2014-02-06
Category : Medical
ISBN : 9780309292498

Get Book

Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Author : H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer
Publisher : Springer
Page : 0 pages
File Size : 55,8 Mb
Release : 2013-02-27
Category : Medical
ISBN : 3642252397

Get Book

Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by H. Gerhard Vogel,Jochen Maas,Franz J. Hock,Dieter Mayer Pdf

-A landmark in the continuously changing world of drugs -Essential reading for scientists and managers in the pharmaceutical industry involved in drug finding, drug development and decision making in the development process -Of use for government institutions and committees working on official guidelines for drug evaluation worldwide

Author : Hans G. Vogel,Wolfgang H. Vogel
Publisher : Springer Science & Business Media
Page : 790 pages
File Size : 52,5 Mb
Release : 2013-04-17
Category : Medical
ISBN : 9783662033333

Get Book

Drug Discovery and Evaluation by Hans G. Vogel,Wolfgang H. Vogel Pdf

This reference book contains a comprehensive selection of the most frequently used assays for reliably detecting pharmacological effects of potential drugs, including tests for cardiovascular, analgesic, psychotropic, metabolic, endocrine, respiratory, renal, and immunomodulatory activities. Each of the over 700 assays comprises a detailed protocol with the purpose and rationale of the method, a description of the experimental procedure, a critical assessment of the results and their pharmacological and clinical relevance, and pertinent references. Identification of specific tests is facilitated by the enclosed CD-ROM which allows for a quick and full text research. An appendix with guidelines and legal regulations for animal experiments in various countries will help to plan these experiments properly in accordance with the welfare of laboratory animals.

Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 43,7 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570

Get Book

Pain Management and the Opioid Epidemic by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse Pdf

Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.

Author : Terry Kenakin
Publisher : Academic Press
Page : 488 pages
File Size : 52,8 Mb
Release : 2018-10-26
Category : Medical
ISBN : 9780128139585

Get Book

A Pharmacology Primer by Terry Kenakin Pdf

A Pharmacology Primer: Techniques for More Effective and Strategic Drug Discovery, Fifth Edition features the latest ideas and research regarding the application of pharmacology to the process of drug discovery. Written by well-respected pharmacologist, Terry P. Kenakin, this primer is an indispensable resource for all those involved in drug discovery. This updated edition has been thoroughly revised to include material on quantifying drug efficacy through bias and cluster analysis, the impact of molecular dynamics and protein structural analysis, the real time kinetic analysis of drug effect, virtual screening for new drug chemical scaffolds, and much more. With full color illustrations and new examples throughout, this book remains a top reference for all industry and academic scientists that is also ideal for students directly involved in drug discovery or pharmacologic research. Highlights changes surrounding strategies for drug discovery, providing a comprehensive reference and featuring advances in the methods involved Includes multiple new sections, such as development and utilization of models in pharmacology, de-orphanization of new drug targets, predicting impact of disease on drug pharmacokinetics, and the impact of enzyme kinetics on drug-drug interactions Illustrates the application of rapid inexpensive assays to predict activity in the therapeutic setting, showing data outcomes and the limitations inherent in interpreting this data

Author : Shayne Cox Gad
Publisher : CRC Press
Page : 477 pages
File Size : 44,6 Mb
Release : 2018-10-26
Category : Medical
ISBN : 9780429781445

Get Book

Toxicology of the Gastrointestinal Tract, Second Edition by Shayne Cox Gad Pdf

Nanoparticles as both potential unique risks and as a valuable approach to increased and higher specificity in delivery of therapeutics A primer on the largest, most diverse, and important microbiome in any mammal "Tricks of the trade" on modifying the oral administration of drugs

Author : Ali S. Faqi
Publisher : Elsevier
Page : 1074 pages
File Size : 53,9 Mb
Release : 2024-02-11
Category : Medical
ISBN : 9780323984621

Get Book

A Comprehensive Guide to Toxicology in Nonclinical Drug Development by Ali S. Faqi Pdf

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

Author : Adrian Kilcoyne,Phil Ambery,Daniel O'Connor
Publisher : OUP Oxford
Page : 473 pages
File Size : 47,5 Mb
Release : 2013-05-23
Category : Medical
ISBN : 9780191510397

Get Book

Pharmaceutical Medicine by Adrian Kilcoyne,Phil Ambery,Daniel O'Connor Pdf

The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.

Author : Roberto Romero-González,Antonia Garrido Frenich
Publisher : Elsevier
Page : 360 pages
File Size : 48,7 Mb
Release : 2017-03-07
Category : Science
ISBN : 9780128096482

Get Book

Applications in High Resolution Mass Spectrometry by Roberto Romero-González,Antonia Garrido Frenich Pdf

Applications of High Resolution Mass Spectrometry: Food Safety and Pesticide Residue Analysis is the first book to offer complete coverage of all aspects of high resolution mass spectrometry (HRMS) used for the analysis of pesticide residue in food. Aimed at researchers and graduate students in food safety, toxicology, and analytical chemistry, the book equips readers with foundational knowledge of HRMS, including established and state-of-the-art principles and analysis strategies. Additionally, it provides a roadmap for implementation, including discussions of the latest instrumentation and software available. Detailed coverage is given to the application of HRMS coupled to ultra high-performance liquid chromatography (UHPLC-HRMS) in the analysis of pesticide residue in fruits and vegetables and food from animal origin. The book also discusses extraction procedures and the challenges of sample preparation, gas chromatography coupled to high resolution mass spectrometry, flow injection-HRMS, ambient ionization, and identification of pesticide transformation products in food. Responding to the fast development and application of these new procedures, this book is an essential resource in the food safety field. Arms researchers with an in-depth resource devoted to the rapid advances in HRMS tools and strategies for pesticide residue analysis in food Provides a complete overview of analytical methodologies and applications of HRMS, including UHPLC-HRMS, HRMS coupled with time of flight (TOF) and/or GC-Orbitrap, and flow injection-HRMS Discusses the current international regulations and legislation related to the use of HRMS in pesticide residue analysis Features a chapter on the hardware and software available for HRMS implementation Offers separate chapters on HRMS applied to pesticide residue analysis in fruits and vegetables and in food from animal origin

Author : American Psychiatric Association
Publisher : American Psychiatric Pub
Page : 226 pages
File Size : 54,5 Mb
Release : 2018-01-11
Category : Medical
ISBN : 9780890426821

Get Book

The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder by American Psychiatric Association Pdf

The guideline focuses specifically on evidence-based pharmacological treatments for AUD in outpatient settings and includes additional information on assessment and treatment planning, which are an integral part of using pharmacotherapy to treat AUD.

Author : Wenru Su,Yong Tao,Xiaomin Zhang,Zhiming Lin,Shengping Hou
Publisher : Frontiers Media SA
Page : 168 pages
File Size : 44,7 Mb
Release : 2022-03-29
Category : Science
ISBN : 9782889748020

Get Book

Advanced Perspectives in Cell Therapy and Correlated Immunopharmacology by Wenru Su,Yong Tao,Xiaomin Zhang,Zhiming Lin,Shengping Hou Pdf