Principles Of Safety Pharmacology
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Principles Of Safety Pharmacology
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Author : Michael K. Pugsley
language : en
Publisher:
Release Date : 2015
Principles Of Safety Pharmacology written by Michael K. Pugsley and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015 with 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 : 2018-09-05
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 2018-09-05 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. 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
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.
Safety Pharmacology
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Author : Y. James Kang
language : en
Publisher:
Release Date : 2006-12-01
Safety Pharmacology written by Y. James Kang and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-12-01 with categories.
Early Drug Development
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Author : Fabrizio Giordanetto
language : en
Publisher: John Wiley & Sons
Release Date : 2018-06-15
Early Drug Development written by Fabrizio Giordanetto 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 2018-06-15 with Science categories.
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.
Principles For Pre Clinical Testing Of Drug Safety
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Author : World Health Organization
language : en
Publisher:
Release Date : 1966-01-01
Principles For Pre Clinical Testing Of Drug Safety written by World Health Organization and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1966-01-01 with categories.
Safety Pharmacology In Pharmaceutical Development
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Author : Shayne C. Gad
language : en
Publisher: CRC Press
Release Date : 2012-04-26
Safety Pharmacology In Pharmaceutical Development written by Shayne C. Gad and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-04-26 with Medical categories.
Safety pharmacology is the evaluation and study of the pharmacological effects of a potential drug that are unrelated to the desired therapeutic effect. These effects often present a hazard-particularly in individuals with compromised or limited organ system functions.Safety Pharmacology in Pharmaceutical Development: Approval and Post Marketing Su
An Introduction To Pharmacovigilance
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Author : Patrick Waller
language : en
Publisher: John Wiley & Sons
Release Date : 2017-05-01
An Introduction To Pharmacovigilance written by Patrick Waller 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 2017-05-01 with Medical categories.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems. This introductory guide is designed to aid the rapid understanding of the key principles of pharmacovigilance. Packed full of examples illustrating drug safety issues it not only covers the processes involved, but the regulatory aspects and ethical and societal considerations of pharmacovigilance. Covering the basics step-by-step, this book is perfect for beginners and is essential reading for those new to drug safety departments and pharmaceutical medicine students. The second edition is thoroughly revised and updated throughout and includes a new chapter on clinical aspects of pharmacovigilance.
Atkinson S Principles Of Clinical Pharmacology
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Author : Shiew-Mei Huang
language : en
Publisher: Academic Press
Release Date : 2021-10-16
Atkinson S Principles Of Clinical Pharmacology written by Shiew-Mei Huang and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-16 with Medical categories.
Atkinson’s Principles of Clinical Pharmacology, Fourth Edition is the essential reference on the pharmacologic principles underlying the individualization of patient therapy and contemporary drug development. This well-regarded survey continues to focus on the basics of clinical pharmacology for the development, evaluation and clinical use of pharmaceutical products while also addressing the most recent advances in the field. Written by leading experts in academia, industry, clinical and regulatory settings, the fourth edition has been thoroughly updated to provide readers with an ideal reference on the wide range of important topics impacting clinical pharmacology. Presents the essential knowledge for effective practice of clinical pharmacology Includes a new chapter and extended discussion on the role of personalized and precision medicine in clinical pharmacology Offers an extensive regulatory section that addresses US and international issues and guidelines Provides extended coverage of earlier chapters on transporters, pharmacogenetics and biomarkers, along with further discussion on "Phase 0" studies (microdosing) and PBPK
Stephens Detection And Evaluation Of Adverse Drug Reactions
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Author : John Talbot
language : en
Publisher: John Wiley & Sons
Release Date : 2011-10-28
Stephens Detection And Evaluation Of Adverse Drug Reactions written by John Talbot 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 2011-10-28 with Medical categories.
The detection and evaluation of adverse drug reactions is crucial for understanding the safety of medicines and for preventing harm in patients. Not only is it necessary to detect new adverse drug reactions, but the principles and practice of pharmacovigilance apply to the surveillance of a wide range of medicinal products. Stephens' Detection and Evaluation of Adverse Drug Reactions provides a comprehensive review of all aspects of adverse drug reactions throughout the life cycle of a medicine, from toxicology and clinical trials through to pharmacovigilance, risk management, and legal and regulatory requirements. It also covers the safety of biotherapeutics and vaccines and includes new chapters on pharmacogenetics, proactive risk management, societal considerations, and the safety of drugs used in oncology and herbal medicines. This sixth edition of the classic text on drug safety is an authoritative reference text for all those who work in pharmacovigilance or have an interest in adverse drug reactions, whether in regulatory authorities, pharmaceutical companies, or academia. Praise for previous editions "This book presents a comprehensive and wide-ranging overview of the science of pharmacovigilance. For those entering or already experienced in the pharmaceutical sciences, this is an essential work.” - from a review in E-STREAMS "...a key text in the area of pharmacovigilance...extensively referenced and well-written...a valuable resource..." - from a review in The Pharmaceutical Journal