January 22, 2021

Download Ebook Free Accelerated Predictive Stability

Accelerated Predictive Stability (APS)

Accelerated Predictive Stability (APS)
Author : Fenghe Qiu,Garry Scrivens
Publisher : Academic Press
Release Date : 2018-06-28
Category : Medical
Total pages :512
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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

Methods for Stability Testing of Pharmaceuticals

Methods for Stability Testing of Pharmaceuticals
Author : Sanjay Bajaj,Saranjit Singh
Publisher : Humana
Release Date : 2019-06-08
Category : Medical
Total pages :358
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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.

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
Category : Medical
Total pages :389
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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.

Accelerated Aging

Accelerated Aging
Author : Robert L. Feller
Publisher : Getty Publications
Release Date : 1995-03-02
Category : Art
Total pages :296
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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 involved and their physical consequences.

Pharmaceutical Stress Testing

Pharmaceutical Stress Testing
Author : Steven W. Baertschi,Karen M. Alsante,Robert A. Reed
Publisher : CRC Press
Release Date : 2016-04-19
Category : Medical
Total pages :612
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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 large molecules, such as proteins and antibodies, and it outlines the changes in stress testing that have emerged in recent years. Key features include: A renowned Editorial team and contributions from all major drug companies, reflecting a wealth of experience. 10 new chapters, including Stress Testing and its relationship to the assessment of potential genotoxic degradants, combination drug therapies, proteins, oligonucleotides, physical changes and alternative dosage forms such as liposomal formulations Updated methodologies for predicting drug stability and degradation pathways Best practice models to follow An expanded Frequently Asked Questions section This is an essential reference book for Pharmaceutical Scientists and those working in Quality Assurance and Drug Development (analytical sciences, formulations, chemical process, project management).

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
Category : Mathematics
Total pages :352
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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 analysis of stability studies. After introducing the basic concepts of stability testing, the book focuses on short-term stability studies and reviews several methods for estimating drug expiration dating periods. It then compares some commonly employed study designs and discusses both fixed and random batch statistical analyses. Following a chapter on the statistical methods for stability analysis under a linear mixed effects model, the book examines stability analyses with discrete responses, multiple components, and frozen drug products. In addition, the author provides statistical methods for dissolution testing and explores current issues and recent developments in stability studies. To ensure the safety of consumers, professionals in the field must carry out stability studies to determine the reliability of drug products during their expiration period. This book provides the material necessary for you to perform stability designs and analyses in pharmaceutical research and development.

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry

Statistical Applications for Chemistry, Manufacturing and Controls (CMC) in the Pharmaceutical Industry
Author : Richard K. Burdick,David J. LeBlond,Lori B. Pfahler,Jorge Quiroz,Leslie Sidor,Kimberly Vukovinsky,Lanju Zhang
Publisher : Springer
Release Date : 2017-02-14
Category : Medical
Total pages :379
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This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.

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
Category : Technology & Engineering
Total pages :600
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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. This book provides a state-of-the-art overview of distributed MPC approaches, while at the same time making clear directions of research that deserve more attention. The core and rationale of 35 approaches are carefully explained. Moreover, detailed step-by-step algorithmic descriptions of each approach are provided. These features make the book a comprehensive guide both for those seeking an introduction to distributed MPC as well as for those who want to gain a deeper insight in the wide range of distributed MPC techniques available.

Shelf Life Assessment of Food

Shelf Life Assessment of Food
Author : Maria Cristina Nicoli
Publisher : CRC Press
Release Date : 2012-05-11
Category : Technology & Engineering
Total pages :316
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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. Offering an integrated view of the present status of shelf life assessment, the book covers: Definitions, basic concepts, and regulatory aspects of food shelf life The shelf life assessment process, including preliminary steps, testing, modeling, and monitoring Methods for determining acceptability limits Critical indicators in shelf life assessment Real-time and accelerated shelf life testing Microbial indicators for shelf life prediction and determination Survival analysis methodologies and their role in modeling shelf life The effect of packaging materials properties in food shelf life assessment The book concludes with a series of case studies involving fresh-cut apple slices, fruit juices, frozen pasta, cheese breadsticks, coffee, frozen shrimp, and fruit-based noncarbonated soft drinks. Each case study begins with a brief presentation of the product and the problem most relevant to the product’s shelf life. The studies first define acceptability limits and identify the indicators of quality loss. Next, the book examines expiration time assessment by instrumental or sensory tools. Providing researchers and food industry operators with up-to-date data and procedures, this volume surveys the most critical factors and methods for obtaining accurate and reliable shelf life dating.

Development and Validation of Analytical Methods

Development and Validation of Analytical Methods
Author : Christopher M. Riley,Thomas W. Rosanske
Publisher : Elsevier
Release Date : 1996-05-29
Category : Science
Total pages :349
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The need to validate an analytical or bioanalytical method is encountered by analysts in the pharmaceutical industry on an almost daily basis, because adequately validated methods are a necessity for approvable regulatory filings. What constitutes a validated method, however, is subject to analyst interpretation because there is no universally accepted industry practice for assay validation. This book is intended to serve as a guide to the analyst in terms of the issues and parameters that must be considered in the development and validation of analytical methods. In addition to the critical issues surrounding method validation, this book also deals with other related factors such as method development, data acquisition, automation, cleaning validation and regulatory considerations. The book is divided into three parts. Part One, comprising two chapters, looks at some of the basic concepts of method validation. Chapter 1 discusses the general concept of validation and its role in the process of transferring methods from laboratory to laboratory. Chapter 2 looks at some of the critical parameters included in a validation program and the various statistical treatments given to these parameters. Part Two (Chapters 3, 4 and 5) of the book focuses on the regulatory perspective of analytical validation. Chapter 3 discusses in some detail how validation is treated by various regulatory agencies around the world, including the United States, Canada, the European Community, Australia and Japan. This chapter also discusses the International Conference on Harmonization (ICH) treatment of assay validation. Chapters 4 and 5 cover the issues and various perspectives of the recent United States vs. Barr Laboratories Inc. case involving the retesting of samples. Part Three (Chapters 6 - 12) covers the development and validation of various analytical components of the pharmaceutical product development process. This part of the book contains specific chapters dedicated to bulk drug substances and finished products, dissolution studies, robotics and automated workstations, biotechnology products, biological samples, analytical methods for cleaning procedures and computer systems and computer-aided validation. Each chapter goes into some detail describing the critical development and related validation considerations for each topic. This book is not intended to be a practical description of the analytical validation process, but more of a guide to the critical parameters and considerations that must be attended to in a pharmaceutical development program. Despite the existence of numerous guidelines including the recent attempts by the ICH to be implemented in 1998, the practical part of assay validation will always remain, to a certain extent, a matter of the personal preference of the analyst or company. Nevertheless, this book brings together the perspectives of several experts having extensive experience in different capacities in the pharmaceutical industry in an attempt to bring some consistency to analytical method development and validation.

Optimal Design for Nonlinear Response Models

Optimal Design for Nonlinear Response Models
Author : Valerii V. Fedorov,Sergei L. Leonov
Publisher : CRC Press
Release Date : 2013-07-15
Category : Mathematics
Total pages :402
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Optimal Design for Nonlinear Response Models discusses the theory and applications of model-based experimental design with a strong emphasis on biopharmaceutical studies. The book draws on the authors' many years of experience in academia and the pharmaceutical industry. While the focus is on nonlinear models, the book begins with an explanation of

The Fundamentals of Stability Testing

The Fundamentals of Stability Testing
Author : Anonim
Publisher : Micelle Press
Release Date : 1992
Category : Health & Fitness
Total pages :23
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Understanding and Measuring the Shelf-Life of Food

Understanding and Measuring the Shelf-Life of Food
Author : R. Steele
Publisher : Woodhead Publishing
Release Date : 2004-05-24
Category : Technology & Engineering
Total pages :407
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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 on modelling food spoilage, measuring and modelling glass transition, detecting spoilage yeasts, measuring lipid oxidation, the design and validation of shelf-life tests and the use of accelerated shelf-life tests. Understanding and measuring the shelf-life of food is an important reference for all those concerned with extending the shelf-life of food. Reviews the key factors in determining shelf-life and how they can be measured Examines the importance of the shelf-life of a product in determining its quality and profitability Brings together the leading international experts in the field

Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare
Author : Tim Sandle
Publisher : Academic Press
Release Date : 2018-11-30
Category : Medical
Total pages :374
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Biocontamination Control for Pharmaceuticals and Healthcare outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. This key part of controlling risk escalation can lead to the contamination of medicinal products, hence necessary tracking precautions are essential. Regulatory authorities have challenged pharmaceutical companies, healthcare providers, and those in manufacturing practice to adopt a holistic approach to contamination control. New technologies are needed to introduce barriers between personnel and the environment, and to provide a rapid and more accurate assessment of risk. This book offers guidance on building a complete biocontamination strategy. Provides the information necessary for a facility to build a complete biocontamination strategy Helps facilities understand the main biocontamination risks to medicinal products Assists the reader in navigating regulatory requirements Provides insight into developing an environmental monitoring program Covers the types of rapid microbiological monitoring methods now available, as well as current legislation

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
Author : Anonim
Publisher : John Wiley & Sons
Release Date : 2013-12-16
Category : Science
Total pages :744
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Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.