Read Books Online and Download eBooks, EPub, PDF, Mobi, Kindle, Text Full Free.
Genotoxicity And Carcinogenicity Testing Of Pharmaceuticals
Download Genotoxicity And Carcinogenicity Testing Of Pharmaceuticals full books in PDF, epub, and Kindle. Read online Genotoxicity And Carcinogenicity Testing Of Pharmaceuticals ebook anywhere anytime directly on your device. Fast Download speed and no annoying ads. We cannot guarantee that every ebooks is available!
Book Synopsis Genotoxicity and Carcinogenicity Testing of Pharmaceuticals by : Michael J. Graziano
Download or read book Genotoxicity and Carcinogenicity Testing of Pharmaceuticals written by Michael J. Graziano and published by Springer. This book was released on 2015-11-02 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
Book Synopsis Genotoxicity and Carcinogenicity Testing of Pharmaceuticals by : Michael J. Graziano
Download or read book Genotoxicity and Carcinogenicity Testing of Pharmaceuticals written by Michael J. Graziano and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an overview of the nonclinical testing strategies that are used to asses and de-risk the genotoxicity and carcinogenicity properties of human pharmaceuticals. It includes a review of relevant ICH guidelines, numerous case studies where follow-up studies were conducted to further investigate positive findings, and practical considerations for the use of alternative and emerging tests. With contributions from recognized experts in the pharmaceutical industry and health authorities, this volume presents a balanced view on the interpretation and application of genotoxicity and carcinogenicity regulatory guidances. Genotoxicity and Carcinogenicity Testing of Pharmaceuticals is a valuable resource for scientists, regulators, and consultants that are engaged in the conduct, reporting, and review of nonclinical studies. This book will also help academicians better understand and appreciate the complexity of the regulations and breadth of toxicology research that are necessary to support the development and marketing of new drugs.
Author :Jan Willem van der Laan Publisher :Springer Science & Business Media ISBN 13 :1461459508 Total Pages :322 pages Book Rating :4.4/5 (614 download)
Book Synopsis Global Approach in Safety Testing by : Jan Willem van der Laan
Download or read book Global Approach in Safety Testing written by Jan Willem van der Laan and published by Springer Science & Business Media. This book was released on 2013-02-11 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.
Book Synopsis Pharmaceutical Medicine by : Adrian Kilcoyne
Download or read book Pharmaceutical Medicine written by Adrian Kilcoyne and published by OUP Oxford. This book was released on 2013-05-23 with total page 473 pages. Available in PDF, EPUB and Kindle. Book excerpt: The breadth of the pharmaceutical medicine can be daunting, but this book is designed to navigate a path through the speciality. Providing a broad overview of all topics relevant to the discipline of pharmaceutical medicine, it gives you the facts fast, in a user-friendly format, without having to dive through page upon page of dense text. With 136 chapters spread across 8 sections, the text offers a thorough grounding in issues ranging from medicines regulation to clinical trial design and data management. This makes it a useful revision aid for exams as well as giving you a taster of areas of pharmaceutical medicine adjacent to your current role. For healthcare professionals already working in the field, this book offers a guiding hand in difficult situations as well as supplying rapid access to the latest recommendations and guidelines. Written by authors with experience in the industry and drug regulation, this comprehensive and authoritative guide provides a shoulder to lean on throughout your pharmaceutical career.
Book Synopsis Mutagenic Impurities by : Andrew Teasdale
Download or read book Mutagenic Impurities written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2022-02-15 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Genetic Toxicology Testing by : Ray Proudlock
Download or read book Genetic Toxicology Testing written by Ray Proudlock and published by Academic Press. This book was released on 2016-05-28 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic Toxicology Testing: A Laboratory Manual presents a practical guide to genetic toxicology testing of chemicals in a GLP environment. The most commonly used assays are described, from laboratory and test design to results analysis. In a methodical manner, individual test methods are described step-by-step, along with equipment, suggested suppliers, recipes for reagents, and evaluation criteria. An invaluable resource in the lab, this book will help to troubleshoot any assay problems you may encounter to optimise quality and efficiency in your genetic toxicology tests. Genetic Toxicology Testing: A Laboratory Manual is an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own. Offers practical and consistent guidance on the most commonly-performed tests and procedures in a genetic toxicology lab Describes standard genetic toxicology assays, their methodology, reagents, suppliers, and analysis of their results Includes guidance on general approaches: formulation for in vitro assays, study monitoring, and Good Laboratory Practice (GLP) Serves as an essential reference for those new to the genetic toxicology laboratory, or anyone involved in setting up their own lab
Book Synopsis Insight on Genotoxicity by : Shiv Shankar Shukla
Download or read book Insight on Genotoxicity written by Shiv Shankar Shukla and published by CRC Press. This book was released on 2020-10-14 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Oligonucleotide-Based Drugs and Therapeutics by : Nicolay Ferrari
Download or read book Oligonucleotide-Based Drugs and Therapeutics written by Nicolay Ferrari and published by John Wiley & Sons. This book was released on 2018-07-31 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive review of contemporary antisense oligonucleotides drugs and therapeutic principles, methods, applications, and research Oligonucleotide-based drugs, in particular antisense oligonucleotides, are part of a growing number of pharmaceutical and biotech programs progressing to treat a wide range of indications including cancer, cardiovascular, neurodegenerative, neuromuscular, and respiratory diseases, as well as other severe and rare diseases. Reviewing fundamentals and offering guidelines for drug discovery and development, this book is a practical guide covering all key aspects of this increasingly popular area of pharmacology and biotech and pharma research, from the basic science behind antisense oligonucleotides chemistry, toxicology, manufacturing, to safety assessments, the design of therapeutic protocols, to clinical experience. Antisense oligonucleotides are single strands of DNA or RNA that are complementary to a chosen sequence. While the idea of antisense oligonucleotides to target single genes dates back to the 1970's, most advances have taken place in recent years. The increasing number of antisense oligonucleotide programs in clinical development is a testament to the progress and understanding of pharmacologic, pharmacokinetic, and toxicologic properties as well as improvement in the delivery of oligonucleotides. This valuable book reviews the fundamentals of oligonucleotides, with a focus on antisense oligonucleotide drugs, and reports on the latest research underway worldwide. • Helps readers understand antisense molecules and their targets, biochemistry, and toxicity mechanisms, roles in disease, and applications for safety and therapeutics • Examines the principles, practices, and tools for scientists in both pre-clinical and clinical settings and how to apply them to antisense oligonucleotides • Provides guidelines for scientists in drug design and discovery to help improve efficiency, assessment, and the success of drug candidates • Includes interdisciplinary perspectives, from academia, industry, regulatory and from the fields of pharmacology, toxicology, biology, and medicinal chemistry Oligonucleotide-Based Drugs and Therapeutics belongs on the reference shelves of chemists, pharmaceutical scientists, chemical biologists, toxicologists and other scientists working in the pharmaceutical and biotechnology industries. It will also be a valuable resource for regulatory specialists and safety assessment professionals and an important reference for academic researchers and post-graduates interested in therapeutics, antisense therapy, and oligonucleotides.
Download or read book Genotoxicity written by Andor Kocsis and published by Nova Science Publishers. This book was released on 2009 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book looks at genotoxicity which is a deleterious action on cell genetic material affecting its integrity. Genotoxic substances are known to be potentially mutagenic or carcinogenic, specifically those capable of causing genetic mutation and of contributing to the development of tumours. In humans, DNA damage or genotoxicity may be caused by exposure to outside agents like radiation, pesticides, combustion of hydrocarbon products as well as antineoplastic drugs. DNA damage could also come from inside of the body, determined mainly by excessive free radical production generated by some disease process. The importance then, is to identify the genotoxity and try to protect the body, which may be as simple as removing the source of exposure or providing protection against such agents. This new important book gathers the latest research from around the globe in this dynamic field of study.
Book Synopsis Toxicogenomics in Predictive Carcinogenicity by : Russell S Thomas
Download or read book Toxicogenomics in Predictive Carcinogenicity written by Russell S Thomas and published by Royal Society of Chemistry. This book was released on 2016-06-16 with total page 524 pages. Available in PDF, EPUB and Kindle. Book excerpt: Research over the past decade has demonstrated that TGx methods of various types can be used to discriminate modes of mutagenesis as a function of dose. TGx can quickly inform safety evaluation regarding potential mechanisms of conventional outcomes and can provide essential dose-response information. This can then be used to ascertain the sequence of key events in a putative mode of action as may apply in quantitative cancer risk assessment. With the increasing complexity of research in mode of action investigations it is important to gain a better understand of approaches to data integration and health risk assessment. Furthermore, it is essential to consider how novel test systems and newer methods and approaches may be used in future to gain a better understanding of mechanisms. Toxicogenomics in Predictive Carcinogenicity describes toxicogenomics methods in predictive carcinogenicity testing, mode of action and safety evaluation, and cancer risk assessment. It illustrates these methods using case studies that have yielded significant new information on compounds and classes of compounds that have proven difficult to evaluate using conventional methods alone. This book additionally covers current and potential toxicogenomic research using stem cells as well as new bioinformatics methods for drug discovery and environmental toxicology. This publication is an indispensable tool for postgraduates, academics and industrialists working in biochemistry, genomics, carcinogenesis, pathology, pharmaceuticals, food technology, bioinformatics, risk assessment and environmental toxicology.
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.
Book Synopsis Guidance for Industry. Testing for Carcinogenicity of Pharmaceuticals ICH Topic S1B [electronic Resource] by : Canada. Therapeutic Products Programme
Download or read book Guidance for Industry. Testing for Carcinogenicity of Pharmaceuticals ICH Topic S1B [electronic Resource] written by Canada. Therapeutic Products Programme and published by . This book was released on 2000 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis A Comprehensive Guide to Toxicology in Nonclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Nonclinical Drug Development written by Ali S. Faqi and published by Elsevier. This book was released on 2024-02-11 with total page 1074 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Nonclinical Drug Development, Third Edition is a valuable reference providing a complete understanding of all aspects of nonclinical toxicology in pharmaceutical research. This updated edition has been expanded and re-developed covering a wide-range of toxicological issues in small molecules and biologics. Topics include ADME in drug discovery, pharmacokinetics, toxicokinetics, formulations, and genetic toxicology testing. The book has been thoroughly updated throughout to reflect the latest scientific advances and includes new information on antiviral drugs, anti-diabetic drugs, immunotherapy, and a discussion on post-pandemic drug development challenges and opportunities. This is an essential and practical resource for all toxicologists involved in nonclinical testing in industry, academic, and regulatory settings. Provides updated, unique content not covered in one comprehensive resource, including chapters on stem cells, antiviral drugs, anti-diabetic drugs, and immunotherapy Includes the latest international guidelines for nonclinical toxicology in both small and large molecules Incorporates practical examples in order to illustrate day-to-day activities and expectations associated with working in nonclinical toxicology
Book Synopsis A Comprehensive Guide to Toxicology in Preclinical Drug Development by : Ali S. Faqi
Download or read book A Comprehensive Guide to Toxicology in Preclinical Drug Development written by Ali S. Faqi and published by Academic Press. This book was released on 2012-11-02 with total page 904 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Comprehensive Guide to Toxicology in Preclinical Drug Development is designed for toxicologists who need a thorough understanding of the drug development process. This multi-contributed reference will provide a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics --
Book Synopsis Genetic Toxicology by : Albert P. Li
Download or read book Genetic Toxicology written by Albert P. Li and published by CRC Press. This book was released on 1991-03-27 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: Genetic Toxicology is a comprehensive book covering the historical perspective of genetic toxicology; basic mechanisms of mutations and chromosomal effects; health consequences of genetic damage, including cancer and inheritable mutations; properties of physical, chemical, and biological mutagens; risk assessment of human exposure to genotoxicants; and the current position of some government regulatory agencies in the United States on the issues of genetic toxicology. The book will be a useful reference for students and researchers in toxicology, genetics, cancer biology, and medicine who are interested in the basic and applied principles of genetic toxicology. It will also benefit industrial toxicologists, products registration specialists, and government regulatory specialists with responsibility for the safety evaluation of industrial and environmental agents.
Book Synopsis Pharmaceutical Industry Practices on Genotoxic Impurities by : Heewon Lee
Download or read book Pharmaceutical Industry Practices on Genotoxic Impurities written by Heewon Lee and published by CRC Press. This book was released on 2014-08-29 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Drug Safety Evaluation by : Shayne Cox Gad
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-18 with total page 918 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical guide presents a road map for safety assessment as an integral part of the development of new drugs and therapeutics. Helps readers solve scientific, technical, and regulatory issues in preclinical safety assessment and early clinical drug development Explains scientific and philosophical bases for evaluation of specific concerns – including local tissue tolerance, target organ toxicity and carcinogenicity, developmental toxicity, immunogenicity, and immunotoxicity Covers the development of new small and large molecules, generics, 505(b)(2) route NDAs, and biosimilars Revises material to reflect new drug products (small synthetic, large proteins and cells, and tissues), harmonized global and national regulations, and new technologies for safety evaluation Adds almost 20% new and thoroughly updates existing content from the last edition
![Download Guidance for Industry. Testing for Carcinogenicity of Pharmaceuticals ICH Topic S1B [electronic Resource] PDF Online Free](https://books.google.com/books/content/images/frontcover/i5U4YgEACAAJ?fife=w200-h370)
