Author: Nevenka Kragelj Lapanja
Publisher:
ISBN:
Category :
Languages : en
Pages : 153

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Book Description

Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 0470934751
Category : Medical
Languages : en
Pages : 455

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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

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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: 1119551250
Category : Medical
Languages : en
Pages : 544

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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: Paul C. Howard
Publisher: Springer Science & Business Media
ISBN: 1461538009
Category : Science
Languages : en
Pages : 324

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Book Description
Prior to 1979, consideration of the problem of the carcinogenicity of the aromatic amine class of chemicals took place primarily in poster sessions and symposia of annual meetings of the American Association for Cancer Research and analogous international associations. In November 1979 the first meeting concerned with the aromatic amines was held in Rockville, Haryland under primary sponsorship of the National Cancer Institute. The proceedings from this meeting were published as Monograph 58 of the Journal of the National Cancel' Institute in 1981. The second meeting in this series, the Second International Conference on N-Substituted Aryl Compounds, was held in March/April of 1982 in Hot Springs, Arkansas. The National Cancer Institute and The National Center for Toxicological Research were the primary sponsors of this meeting. The proceedings were published as Volume 49 of the journal En-vil'onmental Health Perspectives in 1983. The third meeting in this series was held in April of 1987 at the Dearborn Hyatt in Dearborn, Michigan. The principal sponsor of this meeting was the Heyer L. Pre ntis Comprehensive Cancer Center of Metropolitan Detroit. The proceedings, Carcinogenic and Mutagenic Responses to Aromatic Amines and Nitroal'enes, were published in 1987 by Elsevier Press. The fourth meeting was held in Cleveland, Ohio, on July 15-19, 1989.

Author: Waters Corporation
Publisher: Waters Corporation
ISBN: 9781879732087
Category : Science
Languages : en
Pages : 0

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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: Stavros Kromidas
Publisher: John Wiley & Sons
ISBN: 3527336818
Category : Science
Languages : en
Pages : 378

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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: Maria Rosa Aguilar
Publisher: Elsevier
ISBN: 0857097024
Category : Technology & Engineering
Languages : en
Pages : 587

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Book Description
Smart polymers are polymers that respond to different stimuli or changes in the environment. Smart Polymers and their Applications reviews the types, synthesis, properties, and applications of smart polymers. Chapters in part one focus on types of polymers, including temperature-, pH-, photo-, and enzyme-responsive polymers. Shape memory polymers, smart polymer hydrogels, and self-healing polymer systems are also explored. Part two highlights applications of smart polymers, including smart instructive polymer substrates for tissue engineering; smart polymer nanocarriers for drug delivery; the use of smart polymers in medical devices for minimally invasive surgery, diagnosis, and other applications; and smart polymers for bioseparation and other biotechnology applications. Further chapters discuss the use of smart polymers for textile and packaging applications, and for optical data storage. Smart Polymers and their Applications is a technical resource for chemists, chemical engineers, mechanical engineers, and other professionals in the polymer industry; manufacturers in such sectors as medical, automotive, and aerospace engineering; and academic researchers in polymer science. Reviews the different types of smart polymer, discussing their properties, structure, design, and characterization Reviews applications of smart polymers in such areas as biomedical engineering, textiles, and food packaging

Author: Andrew Teasdale
Publisher: John Wiley & Sons
ISBN: 1118971124
Category : Medical
Languages : en
Pages : 737

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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: Morris J. Brown
Publisher: Elsevier Health Sciences
ISBN: 070207330X
Category : Medical
Languages : en
Pages : 688

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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. ‘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.’ Fully updated throughout. New co-editor: Fraz Mir, Addenbrooke’s Hospital and Department of Medicine, University of Cambridge, Royal College of Physicians Associate International Director for South Asia. Now with free e-book on StudentConsult.