Download or read book Pharmaceutical Stability Testing to Support Global Markets written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2009-12-04 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book International Stability Testing written by David J. Mazzo and published by CRC Press. This book was released on 2020-08-26 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Handbook of Stability Testing in Pharmaceutical Development written by Kim Huynh-Ba and published by Springer Science & Business Media. This book was released on 2008-11-16 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Emerging Technologies and International Stability written by Todd S. Sechser and published by Taylor & Francis. This book was released on 2021-11-28 with total page 308 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Statistical Design and Analysis of Stability Studies written by Shein-Chung Chow and published by CRC Press. This book was released on 2007-05-30 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Fundamentals of Stability Testing written by and published by Micelle Press. This book was released on 1992 with total page 23 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book ICH Quality Guidelines written by Andrew Teasdale and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 740 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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)
Download or read book Drug Stability for Pharmaceutical Scientists written by Thorsteinn Loftsson and published by Academic Press. This book was released on 2014-01-25 with total page 170 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Food and Beverage Stability and Shelf Life written by David Kilcast and published by Elsevier. This book was released on 2011-04-08 with total page 864 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Security and Stability in the New Space Age written by Brad Townsend and published by Routledge. This book was released on 2020-07-12 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines the drivers behind great power security competition in space to determine whether realistic strategic alternatives exist to further militarization. Space is an area of increasing economic and military competition. This book offers an analysis of actions and events indicative of a growing security dilemma in space, which is generating an intensifying arms race between the US, China, and Russia. It explores the dynamics behind a potential future war in space and investigates methods of preventing an arms race from an international relations theory and military-strategy standpoint. The book is divided into three parts: the first section offers a broad discussion of the applicability of international relations theory to current conditions in space; the second is a direct application of theory to the space environment to determine whether competition or cooperation is the optimal strategic choice; the third section focuses on testing the hypotheses against reality, by analyzing novel alternatives to three major categories of space systems. The volume concludes with a study of the practical limitations of applying a strategy centered on commercialization as a method of defusing the orbital security dilemma. This book will be of interest to students of space power, strategic studies, and international relations.
Download or read book Drug Stability and Chemical Kinetics written by Muhammad Sajid Hamid Akash and published by Springer Nature. This book was released on 2020-11-01 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book comprehensively reviews drug stability and chemical kinetics: how external factors can influence the stability of drugs, and the reaction rates that trigger these effects. Explaining the important theoretical concepts of drug stability and chemical kinetics, and providing numerous examples in the form of illustrations, tables and calculations, the book helps readers gain a better understanding of the rates of reactions, order of reactions, types of degradation and how to prevent it, as well as types of stability studies. It also offers insights into the importance of the rate at which the drug is degraded and/or decomposed under various external and internal conditions, including temperature, pH, humidity and light. This book is intended for researchers, PhD students and scientists working in the field of pharmacy, pharmacology, pharmaceutical chemistry, medicinal chemistry and biopharmaceutics.
Download or read book Rules for International Monetary Stability written by Michael Bordo and published by Hoover Press. This book was released on 2017-04-01 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: Since the end of the Great Recession in 2009 the central banks of the advanced countries have taken unprecedented actions to reflate and stimulate their economies. There have been significant differences in the timing and pace of these actions. These independent monetary policy actions have had significant spillover effects on the economies and monetary policy strategies of other advanced countries. In addition the monetary policy actions and interventions of the advanced countries have had a significant impact on the emerging market economies leading to the charge of 'currency wars.' The perceived negative consequences of spillovers from the actions of national central banks has led to calls for international monetary policy coordination. The arguments for coordination based on game theory are the same today as back in the 1980s, which led to accords which required that participant countries follow policies to improve global welfare at the expense of domestic fundamentals. This led to disastrous consequences. An alternative approach to the international spillovers of national monetary policy actions is to view them as deviations from rules based monetary policy.
Download or read book Nutraceuticals in Veterinary Medicine written by Ramesh C. Gupta and published by Springer. This book was released on 2019-05-21 with total page 877 pages. Available in PDF, EPUB and Kindle. Book excerpt: This unique work compiles the latest knowledge around veterinary nutraceuticals, commonly referred to as dietary supplements, from ingredients to final products in a single source. More than sixty chapters organized in seven sections collate all related aspects of nutraceutical research in animal health and disease, among them many novel topics: common nutraceutical ingredients (Section-I), prebiotics, probiotics, synbiotics, enzymes and antibacterial alternatives (Section-II), applications of nutraceuticals in prevention and treatment of various diseases such as arthritis, periodontitis, diabetes, cognitive dysfunctions, mastitis, wounds, immune disorders, and cancer (Section-III), utilization of nutraceuticals in specific animal species (Section-IV), safety and toxicity evaluation of nutraceuticals and functional foods (Section-V), recent trends in nutraceutical research and product development (Section-VI), as well as regulatory aspects for nutraceuticals (Section-VII). The future of nutraceuticals and functional foods in veterinary medicine seems bright, as novel nutraceuticals will emerge and new uses of old agents will be discovered. International contributors to this book cover a variety of specialties in veterinary medicine, pharmacology, pharmacognosy, toxicology, chemistry, medicinal chemistry, biochemistry, physiology, nutrition, drug development, regulatory frameworks, and the nutraceutical industry. This is a highly informative and carefully presented book, providing scientific insight for academia, veterinarians, governmental and regulatory agencies with an interest in animal nutrition, complementary veterinary medicine, nutraceutical product development and research.
Download or read book Pharmaceutical Stress Testing written by Steven W. Baertschi and published by CRC Press. This book was released on 2016-04-19 with total page 626 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Manual on development and use of FAO and WHO specifications for pesticides written by Food and Agriculture Organization of the United Nations and published by Food & Agriculture Org.. This book was released on 2016-01-01 with total page 305 pages. Available in PDF, EPUB and Kindle. Book excerpt: The FAO/WHO Manual on development and use of FAO and WHO specifications for pesticides contains general principles and methodologies of the work undertaken by JMPS, is the continuous evaluation of new scientific developments and guidance documents. The Manual gives the historical background of the operation of the JMPS and describes the purpose of the work. The Manual is also used by countries as a guidance document in setting pesticide specifications. This 3rd revision of the Manual contains n ew methodologies/principles developed in recent 5 years and incorporates the current working principles applied by the JMPS.
Download or read book Methods for Stability Testing of Pharmaceuticals written by Sanjay Bajaj and published by Humana Press. This book was released on 2018-05-25 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product failures and recalls, requires critical and logical thinking that goes beyond the regular documented protocols and methods, so the experiences of the book’s internationally-based expert contributors fill the chapters with practical guidance. As a volume in the Methods in Pharmacology and Toxicology series, this book presents the kind of real-world advice that is essential for advancing laboratory research. Authoritative and thorough, Methods for Stability Testing of Pharmaceuticals serves as a valuable addition to the existing armamentarium of resources available to stability testing personnel in research and industry.
Download or read book The End of Strategic Stability written by Lawrence Rubin and published by Georgetown University Press. This book was released on 2018-09-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: During the Cold War, many believed that the superpowers shared a conception of strategic stability, a coexistence where both sides would compete for global influence but would be deterred from using nuclear weapons. In actuality, both sides understood strategic stability and deterrence quite differently. Today’s international system is further complicated by more nuclear powers, regional rivalries, and nonstate actors who punch above their weight, but the United States and other nuclear powers still cling to old conceptions of strategic stability. The purpose of this book is to unpack and examine how different states in different regions view strategic stability, the use or non-use of nuclear weapons, and whether or not strategic stability is still a prevailing concept. The contributors to this volume explore policies of current and potential nuclear powers including the United States, Russia, China, India, Iran, Israel, Pakistan, and Saudi Arabia. This volume makes an important contribution toward understanding how nuclear weapons will impact the international system in the twenty-first century and will be useful to students, scholars, and practitioners of nuclear weapons policy.
