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International Stability Testing
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Book Synopsis International Stability Testing by : David J. Mazzo
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.
Book Synopsis Pharmaceutical Stability Testing to Support Global Markets by : Kim Huynh-Ba
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.
Book Synopsis Handbook of Stability Testing in Pharmaceutical Development by : Kim Huynh-Ba
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.
Book Synopsis Regulation and Time-effective Design of International Stability Testing by :
Download or read book Regulation and Time-effective Design of International Stability Testing written by and published by . This book was released on 1998 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis International Stability Testing by : David J. Mazzo
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 354 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.
Book Synopsis Statistical Design and Analysis of Stability Studies by : Shein-Chung Chow
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
Book Synopsis ICH Quality Guidelines by : Andrew Teasdale
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)
Book Synopsis Emerging Technologies and International Stability by : Todd S. Sechser
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.
Book Synopsis Drug Stability for Pharmaceutical Scientists by : Thorsteinn Loftsson
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
Book Synopsis Stability Testing Design and Interpretation for the International Registration by : Life Sciences
Download or read book Stability Testing Design and Interpretation for the International Registration written by Life Sciences and published by . This book was released on 2001 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Stability Testing written by BIO-MED. and published by . This book was released on 1999 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Food and Beverage Stability and Shelf Life by : David Kilcast
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 880 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
Book Synopsis The Fundamentals of Stability Testing by :
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:
Book Synopsis Soil Testing, Soil Stability and Ground Improvement by : Wissem Frikha
Download or read book Soil Testing, Soil Stability and Ground Improvement written by Wissem Frikha and published by Springer. This book was released on 2017-07-11 with total page 410 pages. Available in PDF, EPUB and Kindle. Book excerpt: Earthwork projects are critical components in civil construction and often require detailed management techniques and unique solution methods to address failures. Being earth bound, earthwork is influenced by geomaterial properties at the onset of a project. Hence, an understanding of the in-situ soil properties is essential. Slope stability is a common problem facing earthwork construction, such as excavations and shored structures. Analytical methods for slope stability remain critical for researchers due to the mechanical complexity of the system. Striving for better earthwork project managements, the geotechnical engineering community continues to find improved testing techniques for determining sensitive properties of soil and rock, including stress-wave based, non-destructive testing methods. To minimize failure during earthwork construction, past case studies and data may reveal useful lessons and information to improve project management and minimize economic losses. This volume is part of the proceedings of the 1st GeoMEast International Congress and Exhibition on Sustainable Civil Infrastructures, Egypt 2017.
Book Synopsis Security and Stability in the New Space Age by : Brad Townsend
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.
Author :International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Publisher : ISBN 13 :9780662274209 Total Pages :9 pages Book Rating :4.2/5 (742 download)
Book Synopsis Stability Testing : Photostability Testing on New Drug Substances and Products by : International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Download or read book Stability Testing : Photostability Testing on New Drug Substances and Products written by International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and published by . This book was released on 1999 with total page 9 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Accelerated Predictive Stability (APS) by : Fenghe Qiu
Download or read book Accelerated Predictive Stability (APS) written by Fenghe Qiu and published by Academic Press. This book was released on 2018-06-28 with total page 512 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Predictive Stability (APS): Fundamentals and Pharmaceutical Industry Practices provides coverage of both the fundamental principles and pharmaceutical industry applications of the APS approach. Fundamental chapters explain the scientific basis of the APS approach, while case study chapters from many innovative pharmaceutical companies provide a thorough overview of the current status of APS applications in the pharmaceutical industry. In addition, up-to-date experiences in utilizing APS data for regulatory submissions in many regions and countries highlight the potential of APS in support of registration stability testing for certain regulatory submissions. This book provides high level strategies for the successful implementation of APS in a pharmaceutical company. It offers scientists and regulators a comprehensive resource on how the pharmaceutical industry can enhance their understanding of a product’s stability and predict drug expiry more accurately and quickly. Provides a comprehensive, one-stop-shop resource for accelerated predictive stability (APS) Presents the scientific basis of different APS models Includes the applications and utilities of APS that are demonstrated through numerous case studies Covers up-to-date regulatory experience
