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Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher :Unknown
  • Release Date :2021-01-09
  • Total pages :222
  • ISBN : 9780128203330
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Summary : Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by optimizing the developed method, along with validation for different techniques like HPLC, UPLC, UFLC, LC-MS and electrophoresis. This will be an ideal resource for graduate students and professionals working in the pharmaceutical industry, analytical chemistry, regulatory agencies, and those in related academic fields. Concise language for easy understanding of the novel and holistic concept Covers key aspects of analytical development and validation Provides a robust, flexible, operable range for an analytical method with greater excellence and regulatory compliance

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher :Unknown
  • Release Date :2018-03-19
  • Total pages :368
  • ISBN : 9781118895207
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Summary : A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,Phil W. Nethercote
  • Publisher :Unknown
  • Release Date :2014-10-27
  • Total pages :440
  • ISBN : 9783527335633
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Summary : This second edition of a global best-seller has been completely redesigned and extensively rewritten to take into account the new Quality by Design (QbD) concept in pharmaceutical manufacturing. As in the first edition, the analytical requirements during the entire product lifecycle are covered, but now a new section is included on continued performance monitoring and the transfer of analytical procedures. Two case studies from the pharmaceutical industry illustrate the concepts and guidelines presented, and the standards and regulations from the US (FDA), European (EMA) and global (ICH) regulatory authorities are considered throughout. The undisputed gold standard in the field.

Handbook of Modern Pharmaceutical Analysis

Handbook of Modern Pharmaceutical Analysis
  • Author : Satinder Ahuja,Stephen Scypinski
  • Publisher :Unknown
  • Release Date :2010-11-11
  • Total pages :598
  • ISBN : 0123759811
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Summary : Handbook of Modern Pharmaceutical Analysis, Second Edition, synthesizes the complex research and recent changes in the field, while covering the techniques and technology required for today's laboratories. The work integrates strategy, case studies, methodologies, and implications of new regulatory structures, providing complete coverage of quality assurance from the point of discovery to the point of use. Treats pharmaceutical analysis (PA) as an integral partner to the drug development process rather than as a service to it Covers method development, validation, selection, testing, modeling, and simulation studies combined with advanced exploration of assays, impurity testing, biomolecules, and chiral separations Features detailed coverage of QA, ethics, and regulatory guidance (quality by design, good manufacturing practice), as well as high-tech methodologies and technologies from "lab-on-a-chip" to LC-MS, LC-NMR, and LC-NMR-MS

Handbook of Analytical Validation

Handbook of Analytical Validation
  • Author : Michael E. Swartz,Ira S. Krull
  • Publisher :Unknown
  • Release Date :2012-04-24
  • Total pages :220
  • ISBN : 9781420014488
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Summary : Written for practitioners in both the drug and biotechnology industries, the Handbook of Analytical Validation carefully compiles current regulatory requirements on the validation of new or modified analytical methods. Shedding light on method validation from a practical standpoint, the handbook:Contains practical, up-to-date guidelines for analyti

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
  • Author : Ajit S. Narang,Sherif I.F. Badawy
  • Publisher :Unknown
  • Release Date :2018-08-31
  • Total pages :890
  • ISBN : 9780323481038
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Summary : Handbook of Pharmaceutical Wet Granulation: Theory and Practice in a Quality by Design Paradigm offers a single and comprehensive reference dedicated to all aspects of pharmaceutical wet granulation, taking a holistic approach by combining introductory principles with practical solutions. Chapters are written by international experts across industry, academic and regulatory settings, and cover a wide spectrum of relevant and contemporary wet granulation topics, techniques and processes. The books' focus on process analytical technology, quality by design principles, granulation equipment, modeling, scale-up, control and real time release makes it a timely and valuable resource for all those involved in pharmaceutical wet granulation. Discusses fundamentals of theory and current industrial practice in the field of wet granulation, including product and process design and role of material properties in wet granulation Examines the modern evolution of wet granulation through current topics such as established and novel process analytical technologies (PATs), and product development and scale-up paradigms Written for scientists working within the pharmaceutical industry, as well as academics, regulatory officials and equipment vendors who provide PAT tools and granulation equipment

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,John H. McB. Miller
  • Publisher :Unknown
  • Release Date :2006-03-06
  • Total pages :418
  • ISBN : 9783527604470
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Summary : Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.

Handbook for Analytical Quality Control in Water and Wastewater Laboratories

Handbook for Analytical Quality Control in Water and Wastewater Laboratories
  • Author : United States Technology Transfer
  • Publisher :Unknown
  • Release Date :1972
  • Total pages :229
  • ISBN : STANFORD:36105216553417
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Summary :

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher :Unknown
  • Release Date :2019-03-27
  • Total pages :448
  • ISBN : 9780128163726
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Summary : Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers Includes contributions from global leaders and experts from academia, industry and regulatory agencies

Engineering and Design of Constructed Wetlands for Water Quality Impro[ve]ment

Engineering and Design of Constructed Wetlands for Water Quality Impro[ve]ment
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1998
  • Total pages :229
  • ISBN : UCR:31210024757344
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Summary :

The Design Analysis Handbook

The Design Analysis Handbook
  • Author : N. Edward Walker
  • Publisher :Unknown
  • Release Date :1998-02-12
  • Total pages :264
  • ISBN : 0080503926
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Summary : "...A book that should be on the shelf of every digital or analog electronic-system designer." - Frank Goodenough, Electronic Design This Handbook offers design engineers and managers immediately useful, meat-and-potatoes techniques for achieving design validation by analysis in an easy-to-read style. The book contains numerous useful and interesting tips for electronics circuit designers. Examples of rectifier circuits, power supplies, digital timing, thermal analysis, grounding and layout, and EMI/noise control are examined in detail with fully worked-out numerical examples. If you need to create reliable, cost-effective, optimized designs, The Design Analysis Handbook provides a practical framework for integrating quality into the design process from start to finish. The methodology used is called Worst Case Analysis Plus (WCA+), a design-validation tool that demands thoroughness and analytical thinking by the user. A guide to assessing and validating circuit design, The Design Analysis Handbook presents processes and mathematical tools in a straightforward, real-world manner. Unique features of the approach include chapters on safety, bad science, and surviving high-pressure design projects. N. Edward Walker is the president of Design/Analysis Consultants, Inc., based in Tampa, Florida. The Handbook is based on DACI's extensive experience in the design and analysis of highly-reliable electronic systems. Straightforward guide to practical design validation Shows how to avoid design hazards Provides framework for integrating quality with the design process

The SAGE Handbook of Qualitative Data Analysis

The SAGE Handbook of Qualitative Data Analysis
  • Author : Uwe Flick
  • Publisher :Unknown
  • Release Date :2013-12-18
  • Total pages :664
  • ISBN : 9781473971127
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Summary : The wide range of approaches to data analysis in qualitative research can seem daunting even for experienced researchers. This handbook is the first to provide a state-of-the art overview of the whole field of QDA; from general analytic strategies used in qualitative research, to approaches specific to particular types of qualitative data, including talk, text, sounds, images and virtual data. The handbook includes chapters on traditional analytic strategies such as grounded theory, content analysis, hermeneutics, phenomenology and narrative analysis, as well as coverage of newer trends like mixed methods, reanalysis and meta-analysis. Practical aspects such as sampling, transcription, working collaboratively, writing and implementation are given close attention, as are theory and theorization, reflexivity, and ethics. Written by a team of experts in qualitative research from around the world, this handbook is an essential compendium for all qualitative researchers and students across the social sciences.

Manual on Analytical Quality-control for the Water Industry

Manual on Analytical Quality-control for the Water Industry
  • Author : R. V. Cheeseman,Anthony Leslie Wilson
  • Publisher :Unknown
  • Release Date :1978
  • Total pages :157
  • ISBN : UCR:31210025047828
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Summary :

Handbook of Food Process Modeling and Statistical Quality Control

Handbook of Food Process Modeling and Statistical Quality Control
  • Author : Mustafa Ozilgen
  • Publisher :Unknown
  • Release Date :2011-03-01
  • Total pages :704
  • ISBN : 9781439877678
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Summary : Presenting mathematical prerequisites in summary tables, this book explains fundamental techniques of mathematical modeling processes essential to the food industry. The author focuses on providing an in-depth understanding of modeling techniques, rather than the finer mathematical points. Topics covered include modeling of transport phenomena, kin

Design manual

Design manual
  • Author : United States. Naval Facilities Engineering Command
  • Publisher :Unknown
  • Release Date :1974
  • Total pages :430
  • ISBN : UIUC:30112105110503
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Summary :

Handbook of Pharmaceutical Granulation Technology

Handbook of Pharmaceutical Granulation Technology
  • Author : Dilip M. Parikh
  • Publisher :Unknown
  • Release Date :2016-04-19
  • Total pages :676
  • ISBN : 9781616310035
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Summary : The Third Edition presents all pharmaceutical industry personnel and those in academia with critical updates on the recent advances in granulation technology and changes in FDA regulatory guidelines. Addressing precisely how these recent innovations and revisions affect unit operation of particle generation and granulation, this text assists the re

Juran on Quality by Design

Juran on Quality by Design
  • Author : J. M. Juran
  • Publisher :Unknown
  • Release Date :1992
  • Total pages :538
  • ISBN : 9780029166833
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Summary : Offers practical advice on planning, setting, and achieving quality goals, looks at three case studies, and explains why quality is essential for business success

Design of 301(h) Monitoring Programs for Municipal Wastewater Discharges to Marine Waters

Design of 301(h) Monitoring Programs for Municipal Wastewater Discharges to Marine Waters
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1982
  • Total pages :135
  • ISBN : UCR:31210024754754
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Summary :

Handbook for Analytical Quality Control in Water and Wastewater Laboratories

Handbook for Analytical Quality Control in Water and Wastewater Laboratories
  • Author : Analytical Quality Control Laboratory (U.S.)
  • Publisher :Unknown
  • Release Date :1972
  • Total pages :99
  • ISBN : PSU:000049271188
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Summary :

Handbook of Research on Modern Systems Analysis and Design Technologies and Applications

Handbook of Research on Modern Systems Analysis and Design Technologies and Applications
  • Author : Syed, Mahbubur Rahman,Syed, Sharifun Nessa
  • Publisher :Unknown
  • Release Date :2008-07-31
  • Total pages :698
  • ISBN : 9781599048888
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Summary : "This book provides a compendium of terms, definitions, and explanations of concepts in various areas of systems and design, as well as a vast collection of cutting-edge research articles from the field's leading experts"--Provided by publisher.

The Oxford Handbook of Analytical Sociology

The Oxford Handbook of Analytical Sociology
  • Author : Peter Hedström,Peter Bearman
  • Publisher :Unknown
  • Release Date :2011-01-06
  • Total pages :800
  • ISBN : 9780191615238
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Summary : Analytical sociology is a strategy for understanding the social world. It is concerned with explaining important social facts such as network structures, patterns of residential segregation, typical beliefs, cultural tastes, and common ways of acting. It explains such facts by detailing in clear and precise ways the mechanisms through which the social facts were brought about. Making sense of the relationship between micro and macro thus is one of the central concerns of analytical sociology. The approach is a contemporary incarnation of Robert K. Merton's notion of middle-range theory and presents a vision of sociological theory as a tool-box of semi-general theories each of which is adequate for explaining certain types of phenomena. The Handbook brings together some of the most prominent sociologists in the world. Some of the chapters focus on action and interaction as the cogs and wheels of social processes, while others consider the dynamic social processes that these actions and interactions bring about.