Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond


Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond
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Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond


Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond
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Author : Esther Pueyo
language : en
Publisher: Frontiers Media SA
Release Date : 2018-08-16

Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond written by Esther Pueyo and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-08-16 with categories.


Current regulatory guidelines for cardiac safety utilize hERG block and QT interval prolongation as risk markers. This strategy has been successful at preventing harmful drugs from being marketed, but criticized for leading to early withdrawal of potentially safe drugs. Here we collected a series of articles presenting new technological and conceptual advances, including refinement of ex vivo and in vitro assays, screens and models, and in silico approaches reflecting the increasing effort that has been put forward by regulatory agencies, industry, and academia to try and address the need of a more accurate, mechanistically-based paradigm of proarrhythmic potential of drugs. This Research Topic is dedicated to the memory of Dr. J. Jeremy Rice, our wonderful friend and colleague.



Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond


Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond
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Author :
language : en
Publisher:
Release Date : 2018

Safety Pharmacology Risk Assessment Qt Interval Prolongation And Beyond written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018 with categories.


Current regulatory guidelines for cardiac safety utilize hERG block and QT interval prolongation as risk markers. This strategy has been successful at preventing harmful drugs from being marketed, but criticized for leading to early withdrawal of potentially safe drugs. Here we collected a series of articles presenting new technological and conceptual advances, including refinement of ex vivo and in vitro assays, screens and models, and in silico approaches reflecting the increasing effort that has been put forward by regulatory agencies, industry, and academia to try and address the need of a more accurate, mechanistically-based paradigm of proarrhythmic potential of drugs. This Research Topic is dedicated to the memory of Dr. J. Jeremy Rice, our wonderful friend and colleague.



Principles Of Safety Pharmacology


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.



Computational Toxicology For Drug Safety And A Sustainable Environment


Computational Toxicology For Drug Safety And A Sustainable Environment
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Author : Tahmeena Khan, Saman Raza
language : en
Publisher: Bentham Science Publishers
Release Date : 2023-12-18

Computational Toxicology For Drug Safety And A Sustainable Environment written by Tahmeena Khan, Saman Raza and has been published by Bentham Science Publishers this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-18 with Science categories.


Computational Toxicology for Drug Safety and a Sustainable Environment is a primer on computational techniques in environmental toxicology for scholars. The book presents 9 in-depth chapters authored by expert academicians and scientists aimed to give readers an understanding of how computational models, software and algorithms are being used to predict toxicological profiles of chemical compounds. The book also aims to help academics view toxicological assessment from the lens of sustainability by providing an overview of the recent developments in environmentally-friendly practices. The chapters review the strengths and weaknesses of the existing methodologies, and cover new developments in computational tools to explain how researchers aim to get accurate results. Each chapter features a simple introduction and list of references to benefit a broad range of academic readers. List of topics: 1. Applications of computational toxicology in pharmaceuticals, environmental and industrial practices 2. Verification, validation and sensitivity studies of computational models used in toxicology assessment 3. Computational toxicological approaches for drug profiling and development of online clinical repositories 4. How to neutralize chemicals that kill environment and humans: an application of computational toxicology 5. Adverse environmental impact of pharmaceutical waste and its computational assessment 6. Computational aspects of organochlorine compounds: DFT study and molecular docking calculations 7. In-silico studies of anisole and glyoxylic acid derivatives 8. Computational toxicology studies of chemical compounds released from firecrackers 9. Computational nanotoxicology and its applications Readership Graduate and postgraduate students, academics and researchers in pharmacology, computational biology, toxicology and environmental science programs.



Drug Discovery And Evaluation Safety And Pharmacokinetic Assays


Drug Discovery And Evaluation Safety And Pharmacokinetic Assays
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Author : H. Gerhard Vogel
language : en
Publisher: Springer
Release Date : 2013-02-27

Drug Discovery And Evaluation Safety And Pharmacokinetic Assays written by H. Gerhard Vogel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-02-27 with Medical categories.


-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



Advanced Issue Resolution In Safety Pharmacology


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.



Integrated Cardiac Safety


Integrated Cardiac Safety
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Author : J. Rick Turner
language : en
Publisher: John Wiley & Sons
Release Date : 2008-11-26

Integrated Cardiac Safety written by J. Rick Turner 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 2008-11-26 with Medical categories.


The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained, reader-friendly text is valuable to professionals in the pharmaceutical, biotechnology, and CRO industries, pharmacologists, toxicologists, government officials, and students.



Statistical Methods For Evaluating Safety In Medical Product Development


Statistical Methods For Evaluating Safety In Medical Product Development
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Author : A. Lawrence Gould
language : en
Publisher: John Wiley & Sons
Release Date : 2015-02-23

Statistical Methods For Evaluating Safety In Medical Product Development written by A. Lawrence Gould 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 2015-02-23 with Medical categories.


This book gives professionals in clinical research valuable information on the challenging issues of the design, execution, and management of clinical trials, and how to resolve these issues effectively. It also provides understanding and practical guidance on the application of contemporary statistical methods to contemporary issues in safety evaluation during medical product development. Each chapter provides sufficient detail to the reader to undertake the design and analysis of experiments at various stages of product development, including comprehensive references to the relevant literature. Provides a guide to statistical methods and application in medical product development Assists readers in undertaking design and analysis of experiments at various stages of product development Features case studies throughout the book, as well as, SAS and R code



Drug Discovery And Evaluation Methods In Clinical Pharmacology


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".



Predictive Admet


Predictive Admet
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Author : Jianling Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2014-02-28

Predictive Admet written by Jianling Wang 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 2014-02-28 with Medical categories.


This book helps readers integrate in silico, in vitro, and in vivo ADMET (absorption, distribution, metabolism, elimination and toxicity) and PK (pharmacokinetics) data with routine testing applications so that pharmaceutical scientists can diagnose ADMET problems and present appropriate recommendations to move drug discovery programs forward. The book introduces the current clinical practice for drug discovery and development along with the impact on early risk assessment; consolidates the tools and models to intelligently integrate existing in silico, in vitro and in vivo ADMET data; and demonstrates successful cases and lessons learned from real drug discovery and development. In short, it is a book aimed to provide a practical road map for drug discovery and development scientists to generate efficacious and safe drugs for unmet medical needs.