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Book Synopsis Methods for Stability Testing of Pharmaceuticals by : Sanjay Bajaj
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.
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 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 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 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 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
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 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 The Stability and Shelf-Life of Food by : Persis Subramaniam
Download or read book The Stability and Shelf-Life of Food written by Persis Subramaniam and published by Elsevier. This book was released on 2000-08-24 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: The stability and shelf-life of a food product are critical to its success in the market place, yet companies experience considerable difficulties in defining and understanding the factors that influence stability over a desired storage period. This book is the most comprehensive guide to understanding and controlling the factors that determine the shelf-life of food products.
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 Stability and Stability Testing of Pharmaceuticals by :
Download or read book The Stability and Stability Testing of Pharmaceuticals written by and published by . This book was released on 1964 with total page 306 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Analysing Economic Data by : T. Mills
Download or read book Analysing Economic Data written by T. Mills and published by Springer. This book was released on 2013-12-10 with total page 310 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers the key issues required for students wishing to understand and analyse the core empirical issues in economics. It focuses on descriptive statistics, probability concepts and basic econometric techniques and has an accompanying website that contains all the data used in the examples and provides exercises for undertaking original research.
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 Stability of Drugs and Dosage Forms by : Sumie Yoshioka
Download or read book Stability of Drugs and Dosage Forms written by Sumie Yoshioka and published by Springer Science & Business Media. This book was released on 2007-05-08 with total page 274 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug products are complex mixtures of drugs and excipients and, as such, their chemical and physical stability kinetics are complex. This book discusses the stability of these dosage forms with preformulation studies through to the studies on the final products. The book is intended for graduate students, researchers and professionals in the field of Pharmaceutics and Pharmaceutical Chemistry.
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.
Book Synopsis Robust Aeroservoelastic Stability Analysis by : Rick Lind
Download or read book Robust Aeroservoelastic Stability Analysis written by Rick Lind and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 211 pages. Available in PDF, EPUB and Kindle. Book excerpt: The series Advances in Industrial Control aims to report and encourage technology transfer in control engineering. The rapid development of control technology impacts all areas of the control discipline. New theory, new controllers, actuators, sensors, new industrial processes, computer methods, new applications, new philosophies, . . . . , new challenges. Much of this deVelopment work resides in industrial reports, feasibility study papers and the reports of advanced collaborative projects. The series offers an opportunity for researchers to present an extended exposition of such new work in all aspects of industrial control for wider and rapid dissemination. The high performance control systems applications in aerospace and astronautics almost have a tradition of exploiting the most advanced control theoretical developments first. The optimal control and ffitering paradigm associated with the names of Kalman, Bucy, Anderson and Moore found application in the astronautics of the 1960'S and 1970'S. At the beginning of the 1980'S, control theory moved on to robustness, singular values and mu-analysis. This new work was associated with the names of Zames, Doyle, Glover, Balas among others. The Advances in Industrial Control monograph series have published several volumes over the years which have archived the applications experience garnered from applying robust control to the aerospace sector problems. Rick Lind and Marty Brenner add to this set with their volume on robust aeroservoelastic stability. This volume reports the application of the structured singular value to aeroelastic and aeroservoelastic aerospace problems.
Book Synopsis Methods for Stability Testing of Pharmaceuticals by : Sanjay Bajaj
Download or read book Methods for Stability Testing of Pharmaceuticals written by Sanjay Bajaj and published by Humana. This book was released on 2019-06-08 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.
