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

Accelerated Predictive Stability

Accelerated Predictive Stability
  • Author : Fenghe Qiu,Garry Scrivens
  • Publisher : Academic Press
  • Release Date : 2018-05-16
  • ISBN : 012802786X
GET THIS BOOKAccelerated Predictive Stability

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

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.

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

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

Stability of Drugs and Dosage Forms

Stability of Drugs and Dosage Forms
  • Author : Sumie Yoshioka,Valentino J. Stella
  • Publisher : Springer Science & Business Media
  • Release Date : 2007-05-08
  • ISBN : 9780306468292
GET THIS BOOKStability of Drugs and Dosage Forms

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.

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing
  • Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
  • Publisher : CRC Press
  • Release Date : 2016-04-19
  • ISBN : 9781439801802
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

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.

The Syringe Driver

The Syringe Driver
  • Author : Andrew Dickman,Jennifer Schneider
  • Publisher : Oxford University Press
  • Release Date : 2017-04-27
  • ISBN : 9780191053467
GET THIS BOOKThe Syringe Driver

The syringe driver is a simple and cost-effective method of delivering a continuous subcutaneous infusion (CSCI). A CSCI provides a safe and effective way of drug administration and can be used to maintain symptom control in patients who are no longer able to take oral medication. There have been several developments in this field since the third edition of this highly successful book. The text in this edition has been completely revised, incorporating new treatment options and an extensive list

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

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.

Statistical Design and Analysis of Stability Studies

Statistical Design and Analysis of Stability Studies
  • Author : Shein-Chung Chow
  • Publisher : CRC Press
  • Release Date : 2007-05-30
  • ISBN : 1584889063
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

Regression Modeling Strategies

Regression Modeling Strategies
  • Author : Frank E. Harrell
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-03-09
  • ISBN : 9781475734621
GET THIS BOOKRegression Modeling Strategies

Many texts are excellent sources of knowledge about individual statistical tools, but the art of data analysis is about choosing and using multiple tools. Instead of presenting isolated techniques, this text emphasizes problem solving strategies that address the many issues arising when developing multivariable models using real data and not standard textbook examples. It includes imputation methods for dealing with missing data effectively, methods for dealing with nonlinear relationships and for making the estimation of transformations a formal part of

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

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • Author : John Geigert
  • Publisher : Springer
  • Release Date : 2019-05-08
  • ISBN : 9783030137540
GET THIS BOOKThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the