Accelerated Predictive Stability (APS) PDF Download
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Author: Fenghe Qiu
Publisher: Academic Press
ISBN: 0128027851
Category : Medical
Languages : en
Pages : 514
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Book Description
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
Author: Fenghe Qiu
Publisher: Academic Press
ISBN: 0128027851
Category : Medical
Languages : en
Pages : 514
Get Book Here
Book Description
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
Author: Kim Huynh-Ba
Publisher: Springer Science & Business Media
ISBN: 0387856277
Category : Medical
Languages : en
Pages : 389
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Book Description
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.
Author: Obaid, Ahmed J.
Publisher: IGI Global
ISBN: 1799894282
Category : Computers
Languages : en
Pages : 357
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Book Description
The rapid increase of web pages has introduced new challenges for many organizations as they attempt to extract information from a massive corpus of web pages. Finding relevant information, eliminating irregular content, and retrieving accurate results has become extremely difficult in today’s world where there is a surplus of information available. It is crucial to further understand and study web mining in order to discover the best ways to connect users with appropriate information in a timely manner. Advanced Practical Approaches to Web Mining Techniques and Application aims to illustrate all the concepts of web mining and fosters transformative, multidisciplinary, and novel approaches that introduce the practical method of analyzing various web data sources and extracting knowledge by taking into consideration the unique challenges present in the environment. Covering a range of topics such as data science and security threats, this reference work is ideal for industry professionals, researchers, academicians, practitioners, scholars, instructors, and students.
Author: Parul Agarwal
Publisher: Springer Nature
ISBN: 3031236025
Category : Technology & Engineering
Languages : en
Pages : 527
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Book Description
This book provides information on interdependencies of medicine and telecommunications engineering and how the two must rely on each other to effectively function in this era. The book discusses new techniques for medical service improvisation such as clear-cut views on medical technologies. The authors provide chapters on communication essentiality in healthcare, processing of medical amenities using medical images, the importance of data and information technology in medicine, and machine learning and artificial intelligence in healthcare. Authors include researchers, academics, and professionals in the field.
Author: James G. Stavridis
Publisher: NDU Press
ISBN:
Category : Education
Languages : en
Pages : 292
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Book Description
Since its creation in 1963, United States Southern Command has been led by 30 senior officers representing all four of the armed forces. None has undertaken his leadership responsibilities with the cultural sensitivity and creativity demonstrated by Admiral Jim Stavridis during his tenure in command. Breaking with tradition, Admiral Stavridis discarded the customary military model as he organized the Southern Command Headquarters. In its place he created an organization designed not to subdue adversaries, but instead to build durable and enduring partnerships with friends. His observation that it is the business of Southern Command to launch "ideas not missiles" into the command's area of responsibility gained strategic resonance throughout the Caribbean and Central and South America, and at the highest levels in Washington, DC.
Author: Alex Avdeef
Publisher: John Wiley & Sons
ISBN: 0471450251
Category : Science
Languages : en
Pages : 313
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Book Description
Many times drugs work fine when tested outside the body, but when they are tested in the body they fail. One of the major reasons a drug fails is that it cannot be absorb by the body in a way to have the effect it was intended to have. Permeability, Solubility, Dissolution, and Charged State of Ionizable Molecules: Helps drug discovery professionals to eliminate poorly absorbable molecules early in the drug discovery process, which can save drug companies millions of dollars. Extensive tabulations, in appendix format, of properties and structures of about 200 standard drug molecules.
Author: Bertrand Lavédrine
Publisher: Getty Publications
ISBN: 9780892367016
Category : Art
Languages : en
Pages : 304
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Book Description
A resource for the photographic conservator, conservation scientist, curator, as well as professional collector, this volume synthesizes both the masses of research that has been completed to date and the international standards that have been established on the subject.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309119995
Category : Technology & Engineering
Languages : en
Pages : 152
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Book Description
Integrated computational materials engineering (ICME) is an emerging discipline that can accelerate materials development and unify design and manufacturing. Developing ICME is a grand challenge that could provide significant economic benefit. To help develop a strategy for development of this new technology area, DOE and DoD asked the NRC to explore its benefits and promises, including the benefits of a comprehensive ICME capability; to establish a strategy for development and maintenance of an ICME infrastructure, and to make recommendations about how best to meet these opportunities. This book provides a vision for ICME, a review of case studies and lessons learned, an analysis of technological barriers, and an evaluation of ways to overcome cultural and organizational challenges to develop the discipline.
Author:
Publisher: Academic Press
ISBN: 0128156686
Category : Technology & Engineering
Languages : en
Pages : 698
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Book Description
Characterization of Nanoencapsulated Food Ingredients, Volume Four in the Nanoencapsulation in the Food Industry series, introduces some of the common instrumental analysis and characterization methods for the evaluation of nanocarriers and nanoencapsulated ingredients in terms of their morphology, size distribution, surface charge and composition, appearance, physicochemical and rheological properties, and antioxidant activity. Divided in five sections, the book covers the qualitative and quantitative properties of nanoencapsulated food ingredients by different characterization techniques, besides correlating nanocarrier behavior to their physicochemical and functional properties. Authored by a team of global experts in the fields of nano- and microencapsulation of food, nutraceutical, and pharmaceutical ingredients, this title is of great value to those engaged in the various fields of nanoencapsulation and nanodelivery systems. - Shows how different properties of nanoencapsulated food ingredients can be analyzed - Presents the mechanism of each characterization technique - Investigates how the analytical results can be understood with nanoencapsulated ingredients
Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Category : Medical
Languages : en
Pages : 710
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Book Description
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
