International Stability Testing

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Pharmaceutical Stability Testing to Support Global Markets

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 1441908897
Total Pages : 261 pages
Book Rating : 4.4/5 (419 download)

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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.

Handbook of Stability Testing in Pharmaceutical Development

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
ISBN 13 : 0387856277
Total Pages : 389 pages
Book Rating : 4.3/5 (878 download)

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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.

International Stability Testing

Author : David J. Mazzo
Publisher : CRC Press
ISBN 13 : 1000161668
Total Pages : 354 pages
Book Rating : 4.0/5 (1 download)

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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 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.

ICH Quality Guidelines

Author : Andrew Teasdale
Publisher : John Wiley & Sons
ISBN 13 : 1118971132
Total Pages : 624 pages
Book Rating : 4.1/5 (189 download)

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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 2017-09-29 with total page 624 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)

Drug Stability for Pharmaceutical Scientists

Author : Thorsteinn Loftsson
Publisher : Academic Press
ISBN 13 : 0124115624
Total Pages : 170 pages
Book Rating : 4.1/5 (241 download)

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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

International Stability Testing

Author : David J. Mazzo
Publisher : CRC Press
ISBN 13 : 1000122964
Total Pages : 351 pages
Book Rating : 4.0/5 (1 download)

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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.

Statistical Design and Analysis of Stability Studies

Author : Shein-Chung Chow
Publisher : CRC Press
ISBN 13 : 1584889063
Total Pages : 351 pages
Book Rating : 4.5/5 (848 download)

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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

The Fundamentals of Stability Testing

Author :
Publisher : Micelle Press
ISBN 13 : 9780960875252
Total Pages : 23 pages
Book Rating : 4.8/5 (752 download)

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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:

Emerging Technologies and International Stability

Author : Todd S. Sechser
Publisher : Routledge
ISBN 13 : 1000485560
Total Pages : 254 pages
Book Rating : 4.0/5 (4 download)

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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 Routledge. This book was released on 2021-11-28 with total page 254 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.

Food and Beverage Stability and Shelf Life

Author : David Kilcast
Publisher : Elsevier
ISBN 13 : 0857092545
Total Pages : 880 pages
Book Rating : 4.8/5 (57 download)

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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

Stress Testing at the IMF

Author : Mr.Tobias Adrian
Publisher : International Monetary Fund
ISBN 13 : 1513520741
Total Pages : 73 pages
Book Rating : 4.5/5 (135 download)

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Book Synopsis Stress Testing at the IMF by : Mr.Tobias Adrian

Download or read book Stress Testing at the IMF written by Mr.Tobias Adrian and published by International Monetary Fund. This book was released on 2020-02-05 with total page 73 pages. Available in PDF, EPUB and Kindle. Book excerpt: This paper explains specifics of stress testing at the IMF. After a brief section on the evolution of stress tests at the IMF, the paper presents the key steps of an IMF staff stress test. They are followed by a discussion on how IMF staff uses stress tests results for policy advice. The paper concludes by identifying remaining challenges to make stress tests more useful for the monitoring of financial stability and an overview of IMF staff work program in that direction. Stress tests help assess the resilience of financial systems in IMF member countries and underpin policy advice to preserve or restore financial stability. This assessment and advice are mainly provided through the Financial Sector Assessment Program (FSAP). IMF staff also provide technical assistance in stress testing to many its member countries. An IMF macroprudential stress test is a methodology to assess financial vulnerabilities that can trigger systemic risk and the need of systemwide mitigating measures. The definition of systemic risk as used by the IMF is relevant to understanding the role of its stress tests as tools for financial surveillance and the IMF’s current work program. IMF stress tests primarily apply to depository intermediaries, and, systemically important banks.

Accelerated Predictive Stability (APS)

Author : Fenghe Qiu
Publisher : Academic Press
ISBN 13 : 0128027851
Total Pages : 514 pages
Book Rating : 4.1/5 (28 download)

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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 2018-05-14 with total page 514 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

Development and Validation of Analytical Methods

Author : Christopher M. Riley
Publisher : Elsevier
ISBN 13 : 0080530354
Total Pages : 363 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Development and Validation of Analytical Methods by : Christopher M. Riley

Download or read book Development and Validation of Analytical Methods written by Christopher M. Riley and published by Elsevier. This book was released on 1996-05-29 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters.Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic.This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Drug Stability and Chemical Kinetics

Author : Muhammad Sajid Hamid Akash
Publisher : Springer Nature
ISBN 13 : 9811564264
Total Pages : 284 pages
Book Rating : 4.8/5 (115 download)

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Book Synopsis Drug Stability and Chemical Kinetics by : Muhammad Sajid Hamid Akash

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.

Handbook of Financial Stress Testing

Author : J. Doyne Farmer
Publisher :
ISBN 13 : 1108830730
Total Pages : 729 pages
Book Rating : 4.1/5 (88 download)

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Book Synopsis Handbook of Financial Stress Testing by : J. Doyne Farmer

Download or read book Handbook of Financial Stress Testing written by J. Doyne Farmer and published by . This book was released on 2022-04-14 with total page 729 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover current uses and future development of stress tests, the most innovative regulatory tool to prevent and fight financial crises.

Organic Chemistry of Drug Degradation

Author : Min Li
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734216
Total Pages : 311 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Organic Chemistry of Drug Degradation by : Min Li

Download or read book Organic Chemistry of Drug Degradation written by Min Li and published by Royal Society of Chemistry. This book was released on 2012 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines drug degradation pathways with an emphasis on the underlying chemical mechanisms.

Pharmaceutical Stress Testing

Author : Steven W. Baertschi
Publisher : CRC Press
ISBN 13 : 1439801800
Total Pages : 626 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Stress Testing by : Steven W. Baertschi

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