Accelerated 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 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

Produk Detail:

  • Author : Fenghe Qiu
  • Publisher : Academic Press
  • Pages : 512 pages
  • ISBN : 0128027851
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKAccelerated Predictive Stability APS

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

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

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

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

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

Shelf Life Assessment of Food

Shelf Life Assessment of Food
  • Author : Maria Cristina Nicoli
  • Publisher : CRC Press
  • Release : 11 May 2012
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.

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 : 10 November 2013
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.

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

Understanding and Measuring the Shelf-Life of Food

Understanding and Measuring the Shelf-Life of Food
  • Author : R. Steele
  • Publisher : Woodhead Publishing
  • Release : 24 May 2004
GET THIS BOOKUnderstanding and Measuring the Shelf-Life of Food

The shelf-life of a product is critical in determining both its quality and profitability. This important collection reviews the key factors in determining shelf-life and how it can be measured. Part one examines the factors affecting shelf-life and spoilage, including individual chapters on the major types of food spoilage, the role of moisture and temperature, spoilage yeasts, the Maillard reaction and the factors underlying lipid oxidation. Part two addresses the best ways of measuring the shelf-life of foods, with chapters

In Vitro Drug Release Testing of Special Dosage Forms

In Vitro Drug Release Testing of Special Dosage Forms
  • Author : Nikoletta Fotaki,Sandra Klein
  • Publisher : John Wiley & Sons
  • Release : 31 December 2019
GET THIS BOOKIn Vitro Drug Release Testing of Special Dosage Forms

Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at

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

Regression Modeling Strategies

Regression Modeling Strategies
  • Author : Frank E. Harrell
  • Publisher : Springer Science & Business Media
  • Release : 09 March 2013
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

Introduction to Sports Biomechanics

Introduction to Sports Biomechanics
  • Author : Roger Bartlett
  • Publisher : Routledge
  • Release : 12 April 2002
GET THIS BOOKIntroduction to Sports Biomechanics

Introduction to Sports Biomechanics has been developed to introduce you to the core topics covered in the first two years of your degree. It will give you a sound grounding in both the theoretical and practical aspects of the subject. Part One covers the anatomical and mechanical foundations of biomechanics and Part Two concentrates on the measuring techniques which sports biomechanists use to study the movements of the sports performer. In addition, the book is highly illustrated with line drawings