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Accelerated Predictive Stability APS

Accelerated Predictive Stability  APS
  • Author : Fenghe Qiu
  • Publsiher : Academic Press
  • Release : 28 June 2018
  • ISBN : 0128027851
  • Pages : 512 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKAccelerated Predictive Stability APS

Summary:
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


Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS)
  • Author : Fenghe Qiu,Garry Scrivens
  • Publisher : Academic Press
  • Release : 28 June 2018
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

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Methods for Stability Testing of Pharmaceuticals

Methods for Stability Testing of Pharmaceuticals
  • Author : Sanjay Bajaj,Saranjit Singh
  • Publisher : Humana
  • Release : 08 June 2019
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

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Handbook of Stability Testing in Pharmaceutical Development

Handbook of Stability Testing in Pharmaceutical Development
  • Author : Kim Huynh-Ba
  • Publisher : Springer Science & Business Media
  • Release : 16 November 2008
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.

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Food and Beverage Stability and Shelf Life

Food and Beverage Stability and Shelf Life
  • Author : David Kilcast,Persis Subramaniam
  • Publisher : Elsevier
  • Release : 08 April 2011
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

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The Stability and Shelf-Life of Food

The Stability and Shelf-Life of Food
  • Author : Persis Subramaniam,David Kilcast
  • Publisher : Elsevier
  • Release : 24 August 2000
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.

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Pharmaceutical Stress Testing

Pharmaceutical Stress Testing
  • Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
  • Publisher : CRC Press
  • Release : 19 April 2016
GET THIS BOOKPharmaceutical Stress Testing

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 into the physical aspects of stress testing, and incorporates the concept of Quality by Design into the stress testing construct / framework. It has been revised and expanded to include chapters on

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Accelerate

Accelerate
  • Author : Nicole Forsgren PhD,Jez Humble,Gene Kim
  • Publisher : IT Revolution
  • Release : 27 March 2018
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

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Accelerated Aging

Accelerated Aging
  • Author : Robert L. Feller
  • Publisher : Getty Publications
  • Release : 02 March 1995
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

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Statistical Design and Analysis of Stability Studies

Statistical Design and Analysis of Stability Studies
  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release : 30 May 2007
GET THIS BOOKStatistical Design and Analysis of Stability Studies

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 stability studies play an important role in drug safety and quality assurance, Statistical Design and Analysis of Stability Studies presents the principles and methodologies in the design and

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Biomarkers in Drug Development

Biomarkers in Drug Development
  • Author : Michael R. Bleavins,Claudio Carini,Mallé Jurima-Romet,Ramin Rahbari
  • Publisher : John Wiley & Sons
  • Release : 20 September 2011
GET THIS BOOKBiomarkers in Drug Development

Discover how biomarkers can boost the success rate of drugdevelopment efforts As pharmaceutical companies struggle to improve the success rateand cost-effectiveness of the drug development process, biomarkershave emerged as a valuable tool. This book synthesizes and reviewsthe latest efforts to identify, develop, and integrate biomarkersas a key strategy in translational medicine and the drugdevelopment process. Filled with case studies, the bookdemonstrates how biomarkers can improve drug development timelines,lower costs, facilitate better compound selection, reducelate-stage attrition, and open the door

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Feedback Systems

Feedback Systems
  • Author : Karl Johan Åström,Richard M. Murray
  • Publisher : Princeton University Press
  • Release : 02 February 2021
GET THIS BOOKFeedback Systems

The essential introduction to the principles and applications of feedback systems—now fully revised and expanded This textbook covers the mathematics needed to model, analyze, and design feedback systems. Now more user-friendly than ever, this revised and expanded edition of Feedback Systems is a one-volume resource for students and researchers in mathematics and engineering. It has applications across a range of disciplines that utilize feedback in physical, biological, information, and economic systems. Karl Åström and Richard Murray use techniques

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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 : 06 February 2014
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

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Understanding the Magic of the Bicycle

Understanding the Magic of the Bicycle
  • Author : Joseph W Connolly
  • Publisher : Morgan & Claypool Publishers
  • Release : 01 January 2017
GET THIS BOOKUnderstanding the Magic of the Bicycle

The bicycle is a common, yet unique mechanical contraption in our world. In spite of this, the bike's physical and mechanical principles are understood by a select few. You do not have to be a genius to join this small group of people who understand the physics of cycling. This is your guide to fundamental principles (such as Newton's laws) and the book provides intuitive, basic explanations for the bicycle's behaviour. Each concept is introduced and illustrated with simple, everyday

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The Maudsley Prescribing Guidelines in Psychiatry

The Maudsley Prescribing Guidelines in Psychiatry
  • Author : David M. Taylor,Thomas R. E. Barnes,Allan H. Young
  • Publisher : John Wiley & Sons
  • Release : 16 July 2018
GET THIS BOOKThe Maudsley Prescribing Guidelines in Psychiatry

The revised 13th edition of the essential reference for the prescribing of drugs for patients with mental health disorders The revised and updated 13th edition of The Maudsley Prescribing Guidelines in Psychiatry provides up-to-date information, expert guidance on prescribing practice in mental health, including drug choice, treatment of adverse effects and how to augment or switch medications. The text covers a wide range of topics including pharmacological interventions for schizophrenia, bipolar disorder, depression and anxiety, and many other less common

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Continuous Manufacturing for the Modernization of Pharmaceutical Production

Continuous Manufacturing for the Modernization of Pharmaceutical Production
  • Author : National Academies of Sciences, Engineering, and Medicine,Division on Earth and Life Studies,Board on Chemical Sciences and Technology
  • Publisher : National Academies Press
  • Release : 05 April 2019
GET THIS BOOKContinuous Manufacturing for the Modernization of Pharmaceutical Production

On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain

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