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Author: Andrew Teasdale Publisher: John Wiley & Sons ISBN: 0470934751 Category : Medical Languages : en Pages : 455
Book Description
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.
Author: Andrew Teasdale Publisher: John Wiley & Sons ISBN: 0470934751 Category : Medical Languages : en Pages : 455
Book Description
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.
Author: Andrew Teasdale Publisher: John Wiley & Sons ISBN: 1119551218 Category : Medical Languages : en Pages : 548
Book Description
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.
Author: Satinder Ahuja Publisher: Elsevier ISBN: 008050776X Category : Medical Languages : en Pages : 432
Book Description
The United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process-related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is performed at an early stage, there is ample time to address various aspects of drug development to prevent or control the production of impurities and degradation products well before the regulatory filing and thus assure production of a high-quality drug product.This book, therefore, has been designed to meet the need for a reference text on the complex process of isolation and characterization of process-related (synthesis and formulation) impurities and degradation products to meet critical requlatory requirements.It's objective is to provide guidance on isolating and characterizing impurities of pharmaceuticals such as drug candidates, drug substances, and drug products. The book outlines impurity identification processes and will be a key resource document for impurity analysis, isolation/synthesis, and characterization.- Provides valuable information on isolation and characterization of impurities. - Gives a regulatory perspective on the subject. - Describes various considerations involved in meeting regulatory requirements. - Discusses various sources of impurities and degredation products.
Author: Andrew Teasdale Publisher: John Wiley & Sons ISBN: 1119551250 Category : Medical Languages : en Pages : 544
Book Description
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.
Author: Andrew Teasdale Publisher: John Wiley & Sons ISBN: 1118971132 Category : Medical Languages : en Pages : 624
Book Description
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)
Author: Stavros Kromidas Publisher: John Wiley & Sons ISBN: 3527336818 Category : Science Languages : en Pages : 378
Book Description
The rapid development of HPLC instrumentation and technology opens numerous possibilities - and entails new questions. Which column should I choose to obtain best results, which gradient fits to my analytical problem, what are recent and promising trends in detection techniques, what is state of the art regarding LC-MS coupling? All these questions are answered by experts in ten self-contained chapters. Besides these more hardware-related and technical chapters, further related areas of interest are covered: Comparison of recent chromatographic data systems and integration strategies, smart documentation, efficient information search in internet, and tips for a successful FDA inspection. This practical approach offers in a condensed manner recent trends and hints, and will also display the advanced reader mistakes and errors he was not aware of so far.
Author: Waters Corporation Publisher: Waters Corporation ISBN: 9781879732087 Category : Science Languages : en Pages : 0
Book Description
The Comprehensive Guide to HILIC: Hydrophilic Interaction Chromatography, a 72-page book, illustrates how HILIC works and how separation scientists can improve their success in separating and quantifying polar compounds in a variety of sample matrices. Looking for something else? Learn a new technique or technology with the Waters Primers Series, view other titles available here: http://www.wiley.com/go/waters
Author: Maria Rosa Aguilar Publisher: Woodhead Publishing ISBN: 0081024177 Category : Technology & Engineering Languages : en Pages : 704
Book Description
Smart Polymers and Their Applications, Second Edition presents an up-to-date resource of information on the synthesis and properties of different types of smart polymers, including temperature, pH, electro, magnetic and photo-responsive polymers, amongst others. It is an ideal introduction to this field, as well as a review of the latest research in this area. Shape memory polymers, smart polymer hydrogels, and self-healing polymer systems are also explored. In addition, a very strong focus on applications of smart polymers is included for tissue engineering, smart polymer nanocarriers for drug delivery, and the use of smart polymers in medical devices. Additionally, the book covers the use of smart polymers for textile applications, packaging, energy storage, optical data storage, environmental protection, and more. This book is an ideal, technical resource for chemists, chemical engineers, materials scientists, mechanical engineers and other professionals in a range of industries. - Includes a significant number of new chapters on smart polymer materials development, as well as new applications development in energy storage, sensors and devices, and environmental protection - Provides a multidisciplinary approach to the development of responsive polymers, approaching the subject by the different types of polymer (e.g. temperature-responsive) and its range of applications
Author: Morris J. Brown Publisher: Elsevier Health Sciences ISBN: 070207330X Category : Medical Languages : en Pages : 723
Book Description
'The very last thing a drug regulator wishes to be able to say is, like Lord Byron (1788-1824), on the publication of his poem Childe Harold's Pilgrimage, 'I awoke one morning and found myself famous.' The twelfth edition of this long-established textbook of clinical pharmacology (first published in 1960) continues its fine tradition of balancing science and practice for improved evidence-based drug therapy and good prescribing in therapeutic settings increasingly complicated by intercurrent disease and polypharmacy. - Coverage of all major therapeutic topics by body system. - Introductory sections give brief chapter synopses. - Case studies where relevant. - Covers the needs of the developing world with a focus on practical prescribing and health technology assessment. - Definition, tips, brief explanation boxes throughout. - Interesting histories, etymologies and provenances of terms throughout. - Entertaining footnotes throughout. - Fully updated throughout. - New co-editor: Fraz Mir, Addenbrooke's Hospital and Department of Medicine, University of Cambridge. - Now with free e-book on StudentConsult.
Author: Andrew Teasdale
Author: Andrew Teasdale
Author: Andrew Teasdale
Author: Satinder Ahuja
Author: Andrew Teasdale
Author: Andrew Teasdale
Author: Stavros Kromidas
Author: Waters Corporation
Author: Maria Rosa Aguilar
Author: Morris J. Brown
Author: