This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

The second edition of Pharmaceutical Stress Testing: Predicting Drug Degradation provides a practical and scientific guide to designing, executing and interpreting stress testing studies for drug substance and drug product. This is the only guide available to tackle this subject in-depth. The Second Edition expands coverage from chemical stability

The first book devoted to the topic, this reference discusses the predictive power and limitations of current stress testing strategies and emphasizes the critical role of stress testing in the determination of the stability characteristics of pharmaceuticals-offering an extensive compilation of drug degradation studies from real-world examples in the literature.

Electrical Engineering Accelerated Stress Testing Handbook Guide for Achieving Quality Products As we move closer to a genuinely global economy, the pressure to develop highly reliable products on ever-tighter schedules will increase. Part of a designer's "toolbox" for achieving product reliability in a compressed time frame should be a set of best practices for utilizing accelerated stress testing (AST). The Accelerated Stress Testing Handbook delineates a core set of AST practices as part of an overall methodology for enhancing hardware product reliability. The techniques presented will teach readers to identify design deficiencies and problems with component quality or manufacturing processes early in the product's life, and then to take corrective action as quickly as possible. A wide array of case studies gleaned from leading practitioners of AST supplement the theory and methodology, which will provide the reader with a more concrete idea of how AST truly enhances quality in a reduced time frame. Important topics covered include: * Theoretical basis for AST * General AST best practices * AST design and manufacturing processes * AST equipment and techniques * AST process safety qualification In this handbook, AST cases studies demonstrate thermal, vibration, electrical, and liquid stress application; failure mode analysis; and corrective action techniques. Individuals who would be interested in this book include: reliability engineers and researchers, mechanical and electrical engineers, those involved with all facets of electronics and telecommunications product design and manufacturing, and people responsible for implementing quality and process improvement programs.

This volume presents the proceedings of the International Conference on Medical and Biological Engineering held from 16 to 18 March 2017 in Sarajevo, Bosnia and Herzegovina. Focusing on the theme of ‘Pursuing innovation. Shaping the future’, it highlights the latest advancements in Biomedical Engineering and also presents the latest findings, innovative solutions and emerging challenges in this field. Topics include: - Biomedical Signal Processing - Biomedical Imaging and Image Processing - Biosensors and Bioinstrumentation - Bio-Micro/Nano Technologies - Biomaterials - Biomechanics, Robotics and Minimally Invasive Surgery - Cardiovascular, Respiratory and Endocrine Systems Engineering - Neural and Rehabilitation Engineering - Molecular, Cellular and Tissue Engineering - Bioinformatics and Computational Biology - Clinical Engineering and Health Technology Assessment - Health Informatics, E-Health and Telemedicine - Biomedical Engineering Education - Pharmaceutical Engineering

Examining the implications and practical implementation of multi-disciplinary International Conference on Harmonization (ICH) topics, this book gives an integrated view of how the guidelines inform drug development strategic planning and decision-making. • Addresses a consistent need for interpretation, training, and implementation examples of ICH guidelines via case studies • Offers a primary reference point for practitioners addressing the dual challenge of interpretation and practical implementation of ICH guidelines • Uses case studies to help readers understand and apply ICH guidelines • Provides valuable insights into guidelines development, with chapters by authors involved in generating or with experience implementing the guidelines • Includes coverage of stability testing, analytical method validation, impurities, biotechnology drugs and products, and good manufacturing practice (GMP)