Download or read book Safety Evaluation and Regulation of Chemicals 3 written by Freddy Homburger and published by S. Karger AG (Switzerland). This book was released on 1986 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safety Evaluation and Regulation of Chemicals 3 Interface Between Law and Science written by F Homburger (Ed) and published by . This book was released on 1986 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Safety Evaluation and Regulation of Chemicals written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Drug Safety Evaluation written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2016-11-07 with total page 914 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 or read book Regulatory Toxicology Third Edition written by Shayne C. Gad and published by CRC Press. This book was released on 2018-09-03 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: • Describes regulatory testing requirements for all the major classes of marketed products • Explains how to prepare required documents for mandated safety testing of product • Features new chapters addressing Safety Data Sheet Preparation and Regulatory Requirements for GMOs • Covers Safety Data Sheet Preparation, which has replaced the Material Safety Data Sheet system
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on with total page 990 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Download or read book Current Catalog written by National Library of Medicine (U.S.) and published by . This book was released on with total page 1060 pages. Available in PDF, EPUB and Kindle. Book excerpt: First multi-year cumulation covers six years: 1965-70.
Download or read book Drug Safety Evaluation written by Shayne C. Gad and published by Wiley-Interscience. This book was released on 2002-04-18 with total page 1056 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the scientific and philosophical bases for evaluation of specific concerns, such as carcinogenicity and development toxicity.
Download or read book Nonclinical Safety Assessment written by William J. Brock and published by John Wiley & Sons. This book was released on 2013-03-05 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.
Download or read book Safety Evaluation of Pharmaceuticals and Medical Devices written by Shayne C. Gad and published by Springer Science & Business Media. This book was released on 2010-10-26 with total page 135 pages. Available in PDF, EPUB and Kindle. Book excerpt: The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries.
Download or read book Regulatory Toxicology Second Edition written by Shayne C. Gad and published by CRC Press. This book was released on 2001-07-19 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This practical resource provides toxicologists and scientists with essential information on the regulations that govern their jobs and products. Regulatory Toxicology also covers the scientific and historical underpinnings of those regulations. Each chapter provides a grounding in the historical events that led to the development of original legislation and major subsequent changes in legislation. The major administrative divisions for regulatory agencies and their main missions and responsibilities are also detailed, as are the basic filing units or documents the agencies require of individuals to meet goals. This second edition is updated to reflect new developments in the field.
Download or read book NutraSweet Health and Safety Concerns written by United States. Congress. Senate. Committee on Labor and Human Resources and published by . This book was released on 1988 with total page 548 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Preclinical Development Handbook written by Shayne Cox Gad and published by John Wiley & Sons. This book was released on 2008-03-14 with total page 1346 pages. Available in PDF, EPUB and Kindle. Book excerpt: A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.
Download or read book Pharmacology for Chemists written by Raymond Hill and published by Royal Society of Chemistry. This book was released on 2017-10-25 with total page 538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Assuming little previous knowledge of biology, this book aids graduate chemists to close the gap in their knowledge of pharmacology and make the link between medicinal chemistry and the way in which drugs act on the body. The availability of receptor structures has revolutionized drug discovery and development necessitating an up-to-date source of information for chemists entering this new pharmacological world. Chapters, written by experts with an appreciation of most graduate chemists’ knowledge, explain the history of pharmacology, the relationship between receptor structure and function and receptor pharmacology relevant to drug design. Importantly, as drugs are normally discovered in test rather than therapeutic systems, this text describes how pharmacology provides methods to characterize drug activity through scales that allow prediction of drug effect in all systems. Moreover, it outlines the relationship between drug distribution in the body and the action of drugs in particular organ systems relevant to disease. Readers will also find information on pharmacokinetics and drug metabolism, safety pharmacology and toxicology, clinical and regulatory pharmacology and the use of imaging techniques. Carefully edited for relevance to the modern chemist, this unique textbook will be an essential resource for chemists planning to work in drug discovery, or postgraduate students and practicing chemists interested in expanding their pharmacology knowledge
Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Download or read book Interpretation and Extrapolation of Chemical and Biological Carcinogenicity Data to Establish Human Safety Standards written by H.C. Grice and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: The International Life Sciences Institute (lLSI) is a scientific foundation wh ich addresses critical health and safety issues of national and international concern. ILSI promotes international cooperation by pro viding the mechanism for scientists from government, industry and universities to work together on cooperative programs to generate and disseminate scientific data. The members and trustees of the Institute believe that questions regarding health and safety are best resolved when scientists can ex amine and discuss issues, as an independent body, se~arate from the political pressures of individual countries and the economic concerns of individual companies. Frequently, meaningful assessment of the risk of a test substance is hindered by the inherent inconsistencies in the system. The development and refinement of methods and systems to evaluate the safety of chemicals have evolved in a rapid and largely unplanned fashion. Attempts to improve the system have largely been directed toward broad general concerns, with little attention being given to specific problems or issues. A failure to resolve these problems has frequently resulted in increased testing costs and complications in the assessment and extrapolation of the results. Publicity surrounding toxicologic issues has created chronic public apprehension about the ability of science and government to deal effectively with these problems. In response to these difficulties, ILSI has assembled highly qualified and renowned scientists from research institutes, universities, government and industry, with relevant scientific knowledge and expertise regarding the issues that complicate risk assessment procedures.
Download or read book Nature written by Sir Norman Lockyer and published by . This book was released on 1869 with total page 1342 pages. Available in PDF, EPUB and Kindle. Book excerpt:
