Advanced Issue Resolution in Safety Pharmacology

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

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  • Author : Mary Jeanne Kallman
  • Publisher : Academic Press
  • Pages : 360 pages
  • ISBN : 0128123346
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKAdvanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology

Advanced Issue Resolution in Safety Pharmacology
  • Author : Mary Jeanne Kallman,Michael Pugsley
  • Publisher : Academic Press
  • Release : 05 September 2018
GET THIS BOOKAdvanced Issue Resolution in Safety Pharmacology

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

Principles of Safety Pharmacology

Principles of Safety Pharmacology
  • Author : Michael K. Pugsley,Michael J Curtis
  • Publisher : Springer
  • Release : 19 June 2015
GET THIS BOOKPrinciples of Safety Pharmacology

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

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release : 06 February 2014
GET THIS BOOKImproving and Accelerating Therapeutic Development for Nervous System Disorders

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

Drug Discovery and Evaluation: Methods in Clinical Pharmacology

Drug Discovery and Evaluation: Methods in Clinical Pharmacology
  • Author : Franz J. Hock,Michael R. Gralinski
  • Publisher : Springer
  • Release : 01 September 2020
GET THIS BOOKDrug Discovery and Evaluation: Methods in Clinical Pharmacology

This is the second edition of a well-received book in the series “Drug Discovery and Evaluation” The completely revised new edition of the volume reflects the current state of the art in Clinical Pharmacology. 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

Antitargets and Drug Safety

Antitargets and Drug Safety
  • Author : Laszlo Urban,Vinod Patel,Roy J. Vaz
  • Publisher : John Wiley & Sons
  • Release : 08 June 2015
GET THIS BOOKAntitargets and Drug Safety

With its focus on emerging concerns of kinase and GPCR-mediated antitarget effects, this vital reference for drug developers addresses one of the hot topics in drug safety now and in future. Divided into three major parts, the first section deals with novel technologies and includes the utility of adverse event reports to drug discovery, the translational aspects of preclinical safety findings, broader computational prediction of drug side-effects, and a description of the serotonergic system. The main part of the book

Drug Stereochemistry

Drug Stereochemistry
  • Author : Krzysztof Jozwiak,W. J. Lough,Irving W. Wainer
  • Publisher : CRC Press
  • Release : 23 April 2012
GET THIS BOOKDrug Stereochemistry

Drug Stereochemistry: Analytical Methods and Pharmacology, Third Edition covers all aspects of chiral drugs from academic, governmental, industrial, and clinical perspectives, reflecting the many advances in techniques and methodology. Topics include: The use of enzymes in the synthesis and resolution of enantiometrically pure compounds in drug discovery How stereochemistry impacts decisions made in the absorption, distribution, metabolism, excretion, and toxicity (ADMET) stages of drug discovery Pharmacokinetics and pharmacodynamics and the issues faced during the final stages of the drug development

Resolution Pharmacology - Innovative Therapeutic Approaches Based on the Biology of Resolution to Control Chronic Diseases of Western Societies

Resolution Pharmacology - Innovative Therapeutic Approaches Based on the Biology of Resolution to Control Chronic Diseases of Western Societies
  • Author : Mauro Perretti,Trinidad Montero-Melendez,Lucy V. Norling
  • Publisher : Frontiers Media SA
  • Release : 04 November 2019
GET THIS BOOKResolution Pharmacology - Innovative Therapeutic Approaches Based on the Biology of Resolution to Control Chronic Diseases of Western Societies

In this eBook, we have grouped together 16 original contributions which have addressed the translational potential for therapeutics developed on the conceptual framework of the resolution of inflammation. The take home message of our effort, and the efforts of our colleagues who wrote these pieces, is that completely different drugs can be designed and modelled on the mediators and targets of resolution. By implementing this 180° shift in the way we plan the drug development programme (that is by focusing on agonists

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials
  • Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
  • Publisher : National Academies Press
  • Release : 21 January 2011
GET THIS BOOKThe Prevention and Treatment of Missing Data in Clinical Trials

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or

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

The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder
  • Author : American Psychiatric Association
  • Publisher : American Psychiatric Pub
  • Release : 11 January 2018
GET THIS BOOKThe American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder

Alcohol use disorder (AUD) is a major public health problem in the United States. The estimated 12-month and lifetime prevalence values for AUD are 13.9% and 29.1%, respectively, with approximately half of individuals with lifetime AUD having a severe disorder. AUD and its sequelae also account for significant excess mortality and cost the United States more than $200 billion annually. Despite its high prevalence and numerous negative consequences, AUD remains undertreated. In fact, fewer than 1 in 10 individuals in the United States with a 12

Pain Management and the Opioid Epidemic

Pain Management and the Opioid Epidemic
  • 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
  • Release : 28 September 2017
GET THIS BOOKPain Management and the Opioid Epidemic

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

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters
  • Author : Shuguang Ma,Swapan Chowdhury
  • Publisher : Elsevier
  • Release : 09 July 2020
GET THIS BOOKIdentification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters

Identification and Quantification of Drugs, Metabolites, Drug Metabolizing Enzymes, and Transporters, Second Edition, is completely updated to provide an overview of the last decade’s numerous advances in analytical technologies for detection and quantification of drugs, metabolites, and biomarkers. This new edition goes beyond LC-MS and features all-new chapters on how to evaluate drug absorption, distribution, metabolism, and excretion, potential for hepatic and renal toxicity, immunogenicity of biotherapeutics and translational tools for predicting human dosage, safety and efficacy of small

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 : 03 November 2016
GET THIS 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

Spectroscopic Analyses

Spectroscopic Analyses
  • Author : Eram Sharmin,Fahmina Zafar
  • Publisher : BoD – Books on Demand
  • Release : 06 December 2017
GET THIS BOOKSpectroscopic Analyses

The book presents developments and applications of these methods, such as NMR, mass, and others, including their applications in pharmaceutical and biomedical analyses. The book is divided into two sections. The first section covers spectroscopic methods, their applications, and their significance as characterization tools; the second section is dedicated to the applications of spectrophotometric methods in pharmaceutical and biomedical analyses. This book would be useful for students, scholars, and scientists engaged in synthesis, analyses, and applications of materials/polymers.

Pharmacology in Drug Discovery and Development

Pharmacology in Drug Discovery and Development
  • Author : Terry Kenakin
  • Publisher : Academic Press
  • Release : 21 October 2016
GET THIS BOOKPharmacology in Drug Discovery and Development

Pharmacology in Drug Discovery and Development: Understanding Drug Response, Second Edition, is an introductory resource illustrating how pharmacology can be used to furnish the tools necessary to analyze different drug behavior and trace this behavior to its root cause or molecular mechanism of action. The concepts discussed in this book allow for the application of more predictive pharmacological procedures aimed at increasing therapeutic efficacy that will lead to more successful drug development. Chapters logically build upon one another to show

Who Global Report on Traditional and Complementary Medicine 2019

Who Global Report on Traditional and Complementary Medicine 2019
  • Author : World Health Organization
  • Publisher : World Health Organization
  • Release : 16 May 2019
GET THIS BOOKWho Global Report on Traditional and Complementary Medicine 2019

This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and, finally, the country profiles. Apart from the section on practices and practitioners, the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners, which covers providers, education and health insurance, is a new section incorporated to