знания и навыки

учебная и научная литература

научно-популярная литература

медицина / здравоохранение

зарубежная образовательная литература

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.


литературоведение

Nonclinical Safety Assessment. A Guide to International Pharmaceutical Regulations

A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry 


любовные романы

современные любовные романы

современная зарубежная литература

The Role of the Study Director in Nonclinical Studies. Pharmaceuticals, Chemicals, Medical Devices, and Pesticides

The Fontana History of Chemistry, which draws extensively on both the author’s own original research and that of other scholars world wide, is conceived as a work of synthesis. Nothing like it has been attempted in decades.Beginning with the first tentative chemical explorations where primitive technology and techniques were deployed, Dr Brock proceeds via the alchemists’ futile, but frequently profitable, efforts to turn lead into gold to recount the emergence of the modern discipline of chemistry as fashioned by Boyle, Lavoisier and Dalton. He provides a particularly generous critical account of chemical developments during the last 150 years, emphasizing the roles of purity, analysis and synthesis, the exploration of reaction mechanisms, and the industrialization of chemical change, while also weighing up just how chemistry has been taught and disseminated.While brilliantly successful in explaining and exploiting chemical change, modern chemistry – in academy and factory alike – with its recondite language and symbolism and its associations with pollution and danger, prompts more fear than excitement in the uninitiated bystander. This book seeks to enlighten that bystander: to assess links between theory and practice, to reveal recurrent cycles and themes, and to encourage a heightened awareness of the human dimensions of the chemical sciences which might in turn promote a better public understanding of chemistry and the modern chemical and phamaceutical industries..

William J. Brock