Cobert's Manual OF Drug Safety And Pharmacovigilance

A key component of the overall quality of a pharmaceutical is control of impurities, as their presence, even in small amounts, may affect drug safety and efficacy. The identification and quantification of impurities to acceptable standards presents a significant challenge to the analytical chemist. Analytical science is developing rapidly and provides increasing opportunity to identify the structure, and therefore the origin and safety implications of these impurities, and the challenges of their measurement drives the development of modern quantitative methods.

The two volumes LNCS 11982 and 11983 constitute the proceedings of the 11th International Symposium on Cyberspace Safety and Security, CSS 2019, held in Guangzhou, China, in December 2019.

This book explains the translational aspects of ethnomedicinal plants of different geographical regions including India by explaining the medicinal properties against several diseases, genomic evolution in changing environments, metabolic profiling for biomarker discovery, the role of non-coding RNA in the synthesis of secondary metabolites, genome-wide transcriptome profiling, application of pluripotent stem cells for drug discovery, the importance of high-throughput omics, and genome-editing techniques. In addition, some of the chapters have been designed to describe the role of artificial intelligence, plant database, and network-based drug discovery to explore the medicinal importance of compounds as well as challenges and opportunities in drug discovery from ethnomedicinal plants. The book serves as a great source of information for the students, researchers/scientists of diverse fields such as pharmacognosy, plant physiologists, biotechnologists, and pharmaceutical scientists etc., working in the areas of phytotherapy from ethnomedicinal plants.

Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago safety aspects were addressed by pharmacological testing of the selected compound in high doses in tests directed at indications other than the intended indication of the new compound.