Clinical Trials: Study Design, Endpoints And Biomarkers, Drug Safety, And Fda And Ich Guidelines

This book presents information about the use of technology to support the prevention and management of drug safety issues: pharmacovigilance (PV), medication errors, drug-related problems (DRPs), counterfeit medicines and other drug safety issues. Adapting new technologies/information technologies, mobile technologies and social media has contributed effectively to safety practices for medications, with this book providing comprehensive information as a guide to its challenges and potential.

The second edition of this book presents the role of osmolytes in human health and diseases. Some of the chapters deal about the possibility of the use of osmolytes as diagnostic biomarkers and potential drug design for neurodegenerative and other human diseases. Other chapters also include reviews on the role of osmolytes in cancer, metastasis, infectious diseases, metabolic disorders, immunological disorders, and tissue regeneration.

The second edition of this book presents the role of osmolytes in human health and diseases. Some of the chapters deal about the possibility of the use of osmolytes as diagnostic biomarkers and potential drug design for neurodegenerative and other human diseases. Other chapters also include reviews on the role of osmolytes in cancer, metastasis, infectious diseases, metabolic disorders, immunological disorders, and tissue regeneration.

This book discusses some of the most current approaches to diagnosis in a variety of medical specialties. This collection of translational studies provides interesting reviews on pharmacology, drug biomarkers, nephrology and renal physiology, biochemistry, and cellular and molecular biology.

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.