Accelerated Predictive Stability APS

Book Accelerated Predictive Stability  APS  Cover

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  • Publisher : Academic Press
  • Release : 28 June 2018
  • ISBN : 9780128027851
  • Page : 512 pages
  • Rating : 4.5/5 from 103 voters

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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

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Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS)
  • Author : Fenghe Qiu,Garry Scrivens
  • Publisher : Academic Press
  • Release Date : 2018-06-28
  • ISBN : 9780128027851
GET THIS BOOKAccelerated Predictive Stability (APS)

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

Methods for Stability Testing of Pharmaceuticals

Methods for Stability Testing of Pharmaceuticals
  • Author : Sanjay Bajaj,Saranjit Singh
  • Publisher : Humana
  • Release Date : 2019-06-08
  • ISBN : 1493992589
GET THIS BOOKMethods for Stability Testing of Pharmaceuticals

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

Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
  • Author : Kim Huynh-Ba
  • Publisher : Springer Science & Business Media
  • Release Date : 2008-11-16
  • ISBN : 9780387856278
GET THIS BOOKHandbook of Stability Testing in Pharmaceutical Development

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.

Food and Beverage Stability and Shelf Life

Food and Beverage Stability and Shelf Life
  • Author : David Kilcast,Persis Subramaniam
  • Publisher : Elsevier
  • Release Date : 2011-04-08
  • ISBN : 9780857092540
GET THIS BOOKFood and Beverage Stability and Shelf Life

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

The Stability and Shelf-Life of Food

The Stability and Shelf-Life of Food
  • Author : Persis Subramaniam,David Kilcast
  • Publisher : Elsevier
  • Release Date : 2000-08-24
  • ISBN : 9781855736580
GET THIS BOOKThe Stability and Shelf-Life of Food

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.

Accelerated Aging

Accelerated Aging
  • Author : Robert L. Feller
  • Publisher : Getty Publications
  • Release Date : 1995-03-02
  • ISBN : 9780892361250
GET THIS BOOKAccelerated Aging

Accelerated Aging: Photochemical and Thermal Aspects represents the culmination of more than 40 years of research by noted scientist Robert L. Feller. The book focuses on the long-term performance of materials such as wool, dyes, and organic compounds; their resistance to change when exposed to environmental factors such as oxygen, ozone, moisture, heat, and light; and their physical durability with handling and use over time. Processes of deterioration are discussed based on speeded-up laboratory studies designed to clarify the chemical reactions

Distributed Model Predictive Control Made Easy

Distributed Model Predictive Control Made Easy
  • Author : José M. Maestre,Rudy R. Negenborn
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-11-10
  • ISBN : 9789400770065
GET THIS BOOKDistributed Model Predictive Control Made Easy

The rapid evolution of computer science, communication, and information technology has enabled the application of control techniques to systems beyond the possibilities of control theory just a decade ago. Critical infrastructures such as electricity, water, traffic and intermodal transport networks are now in the scope of control engineers. The sheer size of such large-scale systems requires the adoption of advanced distributed control approaches. Distributed model predictive control (MPC) is one of the promising control methodologies for control of such systems.

Shelf Life Assessment of Food

Shelf Life Assessment of Food
  • Author : Maria Cristina Nicoli
  • Publisher : CRC Press
  • Release Date : 2012-05-11
  • ISBN : 9781439846001
GET THIS BOOKShelf Life Assessment of Food

Determining accurate shelf life data for foods is essential for assuring food quality and protecting consumers from the effects of degradation. With a proper balance of theory and practical examples, Shelf Life Assessment of Food presents the essential criteria and current methodologies for obtaining accurate and reliable shelf life dating. Defining the process through a series of sequential steps, the book assists and supports researchers and food industry operators in planning a shelf life study that best suits their needs.

Accelerate

Accelerate
  • Author : Nicole Forsgren PhD,Jez Humble,Gene Kim
  • Publisher : IT Revolution
  • Release Date : 2018-03-27
  • ISBN : 9781942788355
GET THIS BOOKAccelerate

Winner of the Shingo Publication Award Accelerate your organization to win in the marketplace. How can we apply technology to drive business value? For years, we've been told that the performance of software delivery teams doesn't matter―that it can't provide a competitive advantage to our companies. Through four years of groundbreaking research to include data collected from the State of DevOps reports conducted with Puppet, Dr. Nicole Forsgren, Jez Humble, and Gene Kim set out to find a way

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • Author : John Geigert
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-12-06
  • ISBN : 9781441991317
GET THIS BOOKThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals

"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders
  • Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
  • Publisher : National Academies Press
  • Release Date : 2014-02-06
  • ISBN : 9780309292498
GET THIS BOOKImproving and Accelerating Therapeutic Development for Nervous System Disorders

Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective

Accelerated Testing

Accelerated Testing
  • Author : Bryan Dodson,Harry Schwab
  • Publisher : Sae International
  • Release Date : 2006
  • ISBN : 0768006902
GET THIS BOOKAccelerated Testing

Predictive Control for Linear and Hybrid Systems

Predictive Control for Linear and Hybrid Systems
  • Author : Francesco Borrelli,Alberto Bemporad,Manfred Morari
  • Publisher : Cambridge University Press
  • Release Date : 2017-06-22
  • ISBN : 9781107016880
GET THIS BOOKPredictive Control for Linear and Hybrid Systems

With a simple approach that includes real-time applications and algorithms, this book covers the theory of model predictive control (MPC).

The Fundamentals of Stability Testing

The Fundamentals of Stability Testing
  • Author : Anonim
  • Publisher : Micelle Press
  • Release Date : 1992
  • ISBN : 0960875255
GET THIS BOOKThe Fundamentals of Stability Testing

Making Medicines Affordable

Making Medicines Affordable
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
  • Publisher : National Academies Press
  • Release Date : 2018-03-01
  • ISBN : 9780309468084
GET THIS BOOKMaking Medicines Affordable

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs