Genotoxic Impurities
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Pharmaceutical Industry Practices On Genotoxic Impurities
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Author : Heewon Lee
language : en
Publisher: CRC Press
Release Date : 2014-08-29
Pharmaceutical Industry Practices On Genotoxic Impurities written by Heewon Lee and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-08-29 with Medical categories.
A great deal of confusion and uncertainty over genotoxic impurity (GTI) identification, assessment, and control exists in the pharmaceutical industry today. Pharmaceutical Industry Practices on Genotoxic Impurities strives to facilitate scientific and systematic consensus on GTI management by presenting rationales, strategies, methods, interpretati
Genotoxic Impurities
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Author : Andrew Teasdale
language : en
Publisher: John Wiley & Sons
Release Date : 2011-03-29
Genotoxic Impurities written by Andrew Teasdale 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 2011-03-29 with Medical categories.
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.
Mutagenic Impurities
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Author : Andrew Teasdale
language : en
Publisher: John Wiley & Sons
Release Date : 2022-02-15
Mutagenic Impurities written by Andrew Teasdale 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 2022-02-15 with Medical categories.
Learn to implement effective control measures for mutagenic impurities in pharmaceutical development In Mutagenic Impurities: Strategies for Identification and Control, distinguished chemist Andrew Teasdale delivers a thorough examination of mutagenic impurities and their impact on the pharmaceutical industry. The book incorporates the adoption of the ICH M7 guideline and focuses on mutagenic impurities from both a toxicological and analytical perspective. The editor has created a primary reference for any professional or student studying or working with mutagenic impurities and offers readers a definitive narrative of applicable guidelines and practical, tested solutions. It demonstrates the development of effective control measures, including chapters on the purge tool for risk assessment. The book incorporates a discussion of N-Nitrosamines which was arguably the largest mutagenic impurity issue ever faced by the pharmaceutical industry, resulting in the recall of Zantac and similar drugs resulting from N-Nitrosamine contamination. Readers will also benefit from the inclusion of: A thorough introduction to the development of regulatory guidelines for mutagenic and genotoxic impurities, including a historical perspective on the development of the EMEA guidelines and the ICH M7 guideline An exploration of in silico assessment of mutagenicity, including use of structure activity relationship evaluation as a tool in the evaluation of the genotoxic potential of impurities A discussion of a toxicological perspective on mutagenic impurities, including the assessment of mutagenicity and examining the mutagenic and carcinogenic potential of common synthetic reagents Perfect for chemists, analysts, and regulatory professionals, Mutagenic Impurities: Strategies for Identification and Control will also earn a place in the libraries of toxicologists and clinical safety scientists seeking a one-stop reference on the subject of mutagenic impurity identification and control.
Insight On Genotoxicity
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Author : Shiv Shankar Shukla
language : en
Publisher: CRC Press
Release Date : 2020-10-14
Insight On Genotoxicity written by Shiv Shankar Shukla and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-10-14 with Science categories.
Genetic toxicology is considered to be an important assessment tool as there is genetic impact of artificial chemicals. Insight on Genotoxicity discusses testing, mechanism, prediction, and bioindicator of genotoxicity taking into consideration recent advances in nano-engineered particles. Corollary of DNA dent is also discussed in detail taking into consideration the impact of ICH guidelines on genotoxicity testing, which is important for drug discovery innovation and development. Perspective review of genotoxicity evaluation in phytopharmaceuticals has been mentioned along with the prevention of genotoxicity in brief viewpoint. Salient Features Presents methods, standard protocols, and guidelines for genotoxicity testing Examines the impact of ICH Guidelines on genetic toxicity testing which is a regulatory requirement for drug discovery and development Defines appropriate strategies about advances in in vivo genotoxicity testing which have been listed along with progress and prospects Discusses advancement in the high-throughput approaches for genotoxicity testing Details computational prediction of genotoxicity with consideration of mutagenicity, chromosomal damage caused and strategies for computational prediction in drug development
Guidance For Industry
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Author :
language : en
Publisher:
Release Date : 2008
Guidance For Industry written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Drugs categories.
The Medicinal Chemist S Guide To Solving Admet Challenges
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Author : Patrick Schnider
language : en
Publisher: Royal Society of Chemistry
Release Date : 2021-08-27
The Medicinal Chemist S Guide To Solving Admet Challenges written by Patrick Schnider and has been published by Royal Society of Chemistry this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-08-27 with Science categories.
Medicinal chemistry is a complex science that lies at the very heart of drug discovery. Poor solubility, complex metabolism, tissue retention and slow elimination are just some of the properties of investigational compounds that present a challenge to the design and conduct of ADMET studies. Medicinal chemistry experience and knowledge relating to how a lead structure was modified to solve a specific problem is generally very challenging to retrieve. Presented in a visual and accessible style, this book provides rapid solutions to overcome the universal challenges to optimizing ADMET.
Characterization Of Impurities And Degradants Using Mass Spectrometry
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Author : Guodong Chen
language : en
Publisher: John Wiley & Sons
Release Date : 2011-04-27
Characterization Of Impurities And Degradants Using Mass Spectrometry written by Guodong Chen 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 2011-04-27 with Science categories.
The book highlights the current practices and future trends in structural characterization of impurities and degradants. It begins with an overview of mass spectrometry techniques as related to the analysis of impurities and degradants, followed by studies involving characterization of process related impurities (including potential genotoxic impurities), and excipient related impurities in formulated products. Both general practitioners in pharmaceutical research and specialists in analytical chemistry field will benefit from this book that will detail step-by-step approaches and new strategies to solve challenging problems related to pharmaceutical research.
Development And Validation Of Analytical Methods
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Author : Christopher M. Riley
language : en
Publisher: Elsevier
Release Date : 1996-05-29
Development And Validation Of Analytical Methods written by Christopher M. Riley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 1996-05-29 with Science categories.
The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.
Ich Quality Guidelines
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Author : Andrew Teasdale
language : en
Publisher: John Wiley & Sons
Release Date : 2017-10-09
Ich Quality Guidelines written by Andrew Teasdale 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 2017-10-09 with Medical categories.
Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)
Thresholds Of Genotoxic Carcinogens
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Author : Takehiko Nohmi
language : en
Publisher: Academic Press
Release Date : 2016-05-20
Thresholds Of Genotoxic Carcinogens written by Takehiko Nohmi and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-05-20 with Medical categories.
Thresholds of Genotoxic Carcinogens: From Mechanisms to Regulation brings together current opinion and research activities from Japan, the US, and Europe on the subject of genotoxic thresholds. In regulation, it is an adage that genotoxic carcinogens have no thresholds for action, and that they impose cancer risk on humans even at very low levels. This policy is frequently called into question as humans possess a number of defense mechanisms including detoxication, DNA repair, and apoptosis, meaning there is a threshold at which these genotoxic carcinogens take action. The book examines these potential thresholds, describing the potential cancer risks of daily low-level exposure, the mechanisms involved (such as DNA repair, detoxication, translesion DNA synthesis), chemical and statistical methods of analysis, and the ways in which these may be utilized to inform policy. Thresholds of Genotoxic Carcinogens: From Mechanisms to Regulation is an essential reference for any professional researchers in genetic toxicology and those involved in toxicological regulation. Unites an international team of experts to provide a balanced overview of the current opinion on thresholds of genotoxic carcinogens Provides all the information readers need to determine a safe threshold for potential genotoxic carcinogens Includes information on the mechanisms of genotoxic carcinogens and how these can inform regulation Serves as an essential reference for any professional researchers in genetic toxicology and those involved in toxicological regulation