Themed Issue, Safety Pharmacology
Author: Michael Pugsley
Publisher:
Published: 2008
Total Pages: 176
ISBN-13:
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Author: Michael Pugsley
Publisher:
Published: 2008
Total Pages: 176
ISBN-13:
DOWNLOAD EBOOKAuthor: Michael K. Pugsley
Publisher: Springer
Published: 2015-06-19
Total Pages: 477
ISBN-13: 366246943X
DOWNLOAD EBOOKThis 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: Brian L. Strom
Publisher: John Wiley & Sons
Published: 2019-12-16
Total Pages: 1220
ISBN-13: 1119413419
DOWNLOAD EBOOKThis classic, field-defining textbook, now in its sixth edition, provides the most comprehensive guidance available for anyone needing up-to-date information in pharmacoepidemiology. This edition has been fully revised and updated throughout and continues to provide a rounded view on all perspectives from academia, industry and regulatory bodies, addressing data sources, applications and methodologies with great clarity.
Author: Michael K. Pugsley
Publisher:
Published: 2007
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: Shayne C. Gad
Publisher: CRC Press
Published: 2012-04-26
Total Pages: 217
ISBN-13: 1439845670
DOWNLOAD EBOOKSafety 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 Surveillance, Second Edition covers safety pharmacology from the regulatory requirements down to the studies that must be done to justify them. Using the author’s more than 30 years of direct experience, the book incorporates tricks and practical insights for making studies work and understanding why they fail. The second edition includes current regulations, including USFDA and those from Europe and Japan. Presenting a clear description of what is needed and why for supporting drug development, the book focuses on updated test methods, interpretation, and science. It covers the core and supplemental batteries of test procedures and how to do them and provides an overview of available facilities and contract organizations for performing studies.
Author:
Publisher:
Published: 2006
Total Pages: 40
ISBN-13:
DOWNLOAD EBOOKAuthor: Safety Pharmacology Society
Publisher:
Published: 2008
Total Pages:
ISBN-13:
DOWNLOAD EBOOKAuthor: Michael K. Pugsley
Publisher:
Published: 2010
Total Pages: 156
ISBN-13:
DOWNLOAD EBOOKAuthor: Esther Pueyo
Publisher: Frontiers Media SA
Published: 2018-08-16
Total Pages: 385
ISBN-13: 2889455394
DOWNLOAD EBOOKCurrent 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.
Author: Willem K. Amery
Publisher:
Published: 1994
Total Pages: 196
ISBN-13:
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