Genotoxic Impurities

Genotoxic Impurities
Author :
Publisher : John Wiley & Sons
Total Pages : 455
Release :
ISBN-10 : 9780470934753
ISBN-13 : 0470934751
Rating : 4/5 (751 Downloads)

Book Synopsis Genotoxic Impurities by : Andrew Teasdale

Download or read book Genotoxic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2011-03-29 with total page 455 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical perspective. Within these sections, the book defines appropriate strategies to both assess and ultimately control genotoxic impurities, thus aiding the reader to develop effective control measures. An opening section covers the development of guidelines and the threshold of toxicological concern (TTC) and is followed by a section on safety aspects, including safety tests in vivo and vitro, and data interpretation. The second section addresses the risk posed by genotoxic impurities from outside sources and from mutagens within DNA. In the final section, the book deals with the quality perspective of genotoxic impurities focused on two critical aspects, the first being the analysis and the second how to practically evaluate the impurities.


Genotoxic Impurities Related Books

Genotoxic Impurities
Language: en
Pages: 455
Authors: Andrew Teasdale
Categories: Medical
Type: BOOK - Published: 2011-03-29 - Publisher: John Wiley & Sons

GET EBOOK

This book examines genotoxic impurities and their impact on the pharmaceutical industry. Specific sections examine this from both a toxicological and analytical
Pharmaceutical Industry Practices on Genotoxic Impurities
Language: en
Pages: 528
Authors: Heewon Lee
Categories: Medical
Type: BOOK - Published: 2014-08-29 - Publisher: CRC Press

GET EBOOK

A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pha
Mutagenic Impurities
Language: en
Pages: 548
Authors: Andrew Teasdale
Categories: Medical
Type: BOOK - Published: 2022-02-15 - Publisher: John Wiley & Sons

GET EBOOK

Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and
Development and Validation of Analytical Methods
Language: en
Pages: 363
Authors: Christopher M. Riley
Categories: Science
Type: BOOK - Published: 1996-05-29 - Publisher: Elsevier

GET EBOOK

The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequatel
ICH Quality Guidelines
Language: en
Pages: 740
Authors: Andrew Teasdale
Categories: Medical
Type: BOOK - Published: 2017-10-09 - Publisher: John Wiley & Sons

GET EBOOK

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integra