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: Kangping Xiao
Publisher: John Wiley & Sons
ISBN: 1119547857
Category : Science
Languages : en
Pages : 272
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Book Description
This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment. This book explains task management concepts and outlines practical knowledge to help pharmaceutical analytical scientists become productive and enhance their career. •Presents broad topics such as product development process, regulatory requirement, task and project management, innovation mindset, molecular recognition, separation science, degradation chemistry, and statistics. •Provokes thinking through figures, tables, and case studies to help understand how the various functions integrate and how analytical development can work efficiently and effectively by applying science and creativity in their work. •Discusses how to efficiently develop a fit-for-purpose HPLC method without screening dozens of columns, gradients, or mobile phase combinations each time, since the extra effort may not provide enough of a benefit to justify the cost and time in a fast-paced product development environment.
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: National Research Council
Publisher: National Academies Press
ISBN: 030915233X
Category : Nature
Languages : en
Pages : 465
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Book Description
This book is the eighth volume in the series Acute Exposure Guideline Levels for Selected Airborne Chemicals, and reviews AEGLs for acrolein, carbon monoxide, 1,2-dichloroethene, ethylenimine, fluorine, hydrazine, peracetic acid, propylenimine, and sulfur dioxide for scientific accuracy, completeness, and consistency with the NRC guideline reports.
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: James E. Barrett
Publisher: Springer Nature
ISBN: 3030353621
Category : Medical
Languages : en
Pages : 466
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Book Description
Celebrating 100 years of HEP, this volume will discuss key pharmacological discoveries and concepts of the past 100 years. These discoveries have dramatically changed the medical treatment paradigms of many diseases and these concepts have and will continue to shape discovery of new medicinies. Newly evolving technologies will similarly be discussed as they will shape the future of the pharmacology and, accordingly, medical therapy.
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: Valerii V. Fedorov
Publisher: CRC Press
ISBN: 1439821526
Category : Mathematics
Languages : en
Pages : 402
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Book Description
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
