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In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.
The International Conference of Harmonization (ICH) has worked on har- nizing the stability regulations in the US, Europe, and Japan since the early 1990s. Even though the Stability Guidelines Q1A (R2) was issued over a decade ago, issues surrounding this arena continue to surface as the principles described in the guideline are applied to different technical concentrations. As a result, the stability community has continued to discuss concerns and find ways of harmonizing regulatory requirements, streamlining practices, improving processes in order to bring safe and effective medical supplies to the patients around the world. In 2007, the American Association of Pharmaceutical Scientists (AAPS) Stability Focus Group organized two workshops – the Stability Workshop and the Degradation Mechanism Workshop. These meetings attracted many industry scientists as well as representatives from several regulatory agencies in the world to discuss important topics related to pharmaceutical stability practices. Recognizing the importance of documenting these discussions and with the permission of AAPS, I have worked with speakers to assemble a collection of 30 articles from presentations given at these two meetings, mainly the Stability Workshop. I trust that this book will be beneficial to all of you in providing guidance and up-to-date information for building quality stability programs. v Freedom of our mind is Mother of all inventions.
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.
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)
In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.
Technology has always played a central role in international politics; it shapes the ways states fight during wartime and compete during peacetime. Today, rapid advancements have contributed to a widespread sense that the world is again on the precipice of a new technological era. Emerging technologies have inspired much speculative commentary, but academic scholarship can improve the discussion with disciplined theory-building and rigorous empirics. This book aims to contribute to the debate by exploring the role of technology – both military and non-military – in shaping international security. Specifically, the contributors to this edited volume aim to generate new theoretical insights into the relationship between technology and strategic stability, test them with sound empirical methods, and derive their implications for the coming technological age. This book is very novel in its approach. It covers a wide range of technologies, both old and new, rather than emphasizing a single technology. Furthermore, this volume looks at how new technologies might affect the broader dynamics of the international system rather than limiting the focus to a stability. The contributions to this volume walk readers through the likely effects of emerging technologies at each phase of the conflict process. The chapters begin with competition in peacetime, move to deterrence and coercion, and then explore the dynamics of crises, the outbreak of conflict, and war escalation in an environment of emerging technologies. The chapters in this book, except for the Introduction and the Conclusion, were originally published in the Journal of Strategic Studies.
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. This book features valuable content on both aqueous and solid drug solutions, the stability of proteins and peptides, acid-base catalyzed and solvent catalyzed reactions, how drug formulation can influence drug stability, the influence of external factors on reaction rates and much more. Full of examples of real-life formulation problems and step-by-step calculations, this book is the ideal resource for graduate students, as well as scientists in the pharmaceutical and related industries. Illustrates important theoretical concepts with numerous examples, figures, calculations, learning problems and questions for self-study and retention of material Provides answers and explanations to test your knowledge Enables you to better understand key concepts such as rate and order of reaction, reaction equilibrium, complex reaction mechanisms and more Includes an in-depth discussion of both aqueous and solid drug solutions and contains the latest international regulatory requirements on drug stability
Ensuring that foods and beverages remain stable during the required shelf life is critical to their success in the market place, yet companies experience difficulties in this area. Food and beverage stability and shelf life provides a comprehensive guide to factors influencing stability, methods of stability and shelf life assessment and the stability and shelf life of major products.Part one describes important food and beverage quality deterioration processes, including microbiological spoilage and physical instability. Chapters in this section also investigate the effects of ingredients, processing and packaging on stability, among other factors. Part two describes methods for stability and shelf life assessment including food storage trials, accelerated testing and shelf life modelling. Part three reviews the stability and shelf life of a wide range of products, including beer, soft drinks, fruit, bread, oils, confectionery products, milk and seafood.With its distinguished editors and international team of expert contributors, Food and beverage stability and shelf life is a valuable reference for professionals involved in quality assurance and product development and researchers focussing on food and beverage stability. A comprehensive guide to factors influencing stability, methods of stability and shelf life assessment and the stability and shelf life of major products Describes important food and beverage quality deterioration processes exploring microbiological spoilage and physical instability Investigate the effects of ingredients, processing and packaging on stability and documents methods for stability and shelf life assessment