Handbook Of Analytical Quality By Design

Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H Almalki
Publisher : Academic Press
Page : 225 pages
File Size : 52,8 Mb
Release : 2021-01-09
Category : Business & Economics
ISBN : 9780128203330

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Handbook of Analytical Quality by Design by Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H Almalki Pdf

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

Author : Márcia Cristina Breitkreitz,Hector Goicoechea
Publisher : Springer Nature
Page : 268 pages
File Size : 50,9 Mb
Release : 2023-07-13
Category : Medical
ISBN : 9783031315053

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Introduction to Quality by Design in Pharmaceutical Manufacturing and Analytical Development by Márcia Cristina Breitkreitz,Hector Goicoechea Pdf

Written by twenty-five authors from academia, pharmaceutical industry and Pharmacopeias worldwide, this monograph covers the fundamentals and applications of Quality by Design (QbD) and Analytical Quality by Design (AQbD) in a practical and didactic manner. The book starts by describing the motivation and the urgent need for the implementation of the QbD framework in pharmaceutical development, along with the definition of its major elements: Quality Target Product Profile (QTTP), Critical Quality Attributes (CQAs), Critical Process Parameters (CPPs), Critical Material Attributes (CMAs) and the importance of using multivariate methods of Design of Experiments (DOE). The concept of life cycle and regulatory perspectives are discussed. Three chapters are entirely dedicated to DOE theory from screening to optimization designs. Moreover, a comprehensive discussion on modelling and data treatment is presented. Practical aspects of QbD and DOE for pharmaceutical product and process of different dosage forms is included, as well as a practical guide of the input process variables, material attributes, intermediate, and final quality attributes for the most representative pharmaceutical processes. Analytical Quality by Design (AQbD) is also deeply explored, including risk analysis, definitions of Analytical Target Profile (ATP), Method Operable Design Region (MODR) and the life cycle approach, taking into account the compendial and regulatory perspectives. A detailed example of a new chromatographic method for the quality control of a pharmaceutical topical product based on the AQbD procedure is shown. Finally, advanced statistical approaches and DOE methods for extraction studies of bioactive compounds are also presented. The vast amount of information offered in this book provides a comprehensive perspective on QbD, AQbD and DOE principles, essential tools for modern pharmaceutical and analytical development.

Author : Walkiria S. Schlindwein,Mark Gibson
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 41,9 Mb
Release : 2018-01-11
Category : Science
ISBN : 9781118895221

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Pharmaceutical Quality by Design by Walkiria S. Schlindwein,Mark Gibson Pdf

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.

Author : Sarwar Beg,Md Saquib Hasnain
Publisher : Academic Press
Page : 448 pages
File Size : 46,5 Mb
Release : 2019-03-27
Category : Business & Economics
ISBN : 9780128163726

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Pharmaceutical Quality by Design by Sarwar Beg,Md Saquib Hasnain Pdf

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

Author : Satinder Ahuja,Stephen Scypinski
Publisher : Academic Press
Page : 598 pages
File Size : 51,8 Mb
Release : 2010-11-11
Category : Medical
ISBN : 0123759811

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Handbook of Modern Pharmaceutical Analysis by Satinder Ahuja,Stephen Scypinski Pdf

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

Author : Michael E. Swartz,Ira S. Krull
Publisher : CRC Press
Page : 220 pages
File Size : 43,5 Mb
Release : 2012-04-24
Category : Medical
ISBN : 9781420014488

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Handbook of Analytical Validation by Michael E. Swartz,Ira S. Krull Pdf

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

Author : Amit Kumar Nayak,Kalyan Kumar Sen
Publisher : Elsevier
Page : 759 pages
File Size : 46,9 Mb
Release : 2023-12-09
Category : Medical
ISBN : 9780323972468

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Dosage Forms, Formulation Developments and Regulations by Amit Kumar Nayak,Kalyan Kumar Sen Pdf

Dosage Forms, Formulation Developments and Regulations, Volume One in the Recent and Future Trends in Pharmaceutics series, explores aspects of pharmaceutics, with an original approach focused on technology, novelties and future trends in the field. The book discusses the most recent developments in pharmaceutical preformulation and formulation studies, biopharmaceutics and novel pharmaceutical formulations, regulatory affairs, and good manufacturing practices. Exciting areas such as formulation strategies, optimization techniques, the biopharmaceutical classification system, and pharmaceutical aerosols are included. The field of pharmaceutics is highly dynamic and rapidly expanding day-by-day, so it demands a variety of amplified efforts for designing and developing pharmaceutical processes and formulation strategies. This is an essential reference for researchers in academia and industry as well as advanced graduate students in pharmaceutics. Examines trends and recent technologies in dosage, formulation and regulation Contains contributions from leading experts in academia, research, industry and regulatory agencies Includes high-quality illustrations, flow charts and tables for easy understanding of concepts Discusses practical examples and research case studies

Author : Ajit S. Narang,Sherif I.F. Badawy
Publisher : Academic Press
Page : 890 pages
File Size : 48,7 Mb
Release : 2018-08-31
Category : Medical
ISBN : 9780323481038

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Handbook of Pharmaceutical Wet Granulation by Ajit S. Narang,Sherif I.F. Badawy Pdf

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

Author : Analytical Quality Control Laboratory (U.S.),United States. Environmental Protection Agency. Office of Technology Transfer
Publisher : Unknown
Page : 120 pages
File Size : 52,5 Mb
Release : 1972
Category : Water
ISBN : STANFORD:36105216553417

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Handbook for Analytical Quality Control in Water and Wastewater Laboratories by Analytical Quality Control Laboratory (U.S.),United States. Environmental Protection Agency. Office of Technology Transfer Pdf

Author : Klara Valko
Publisher : Elsevier
Page : 612 pages
File Size : 44,9 Mb
Release : 2000-10-13
Category : Science
ISBN : 0080541097

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Separation Methods in Drug Synthesis and Purification by Klara Valko Pdf

Separation Methods in Drug Synthesis and Purification

Author : Nelu Grinberg,Sonia Rodriguez
Publisher : CRC Press
Page : 1614 pages
File Size : 45,8 Mb
Release : 2019-02-21
Category : Medical
ISBN : 9781351644310

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Ewing's Analytical Instrumentation Handbook, Fourth Edition by Nelu Grinberg,Sonia Rodriguez Pdf

This handbook is a guide for workers in analytical chemistry who need a starting place for information about a specific instrumental technique. It gives a basic introduction to the techniques and provides leading references on the theory and methodology for an instrumental technique. This edition thoroughly expands and updates the chapters to include concepts, applications, and key references from recent literature. It also contains a new chapter on process analytical technology.

Author : Anil K. Philip,Aliasgar Shahiwala,Mamoon Rashid,Md Faiyazuddin
Publisher : Academic Press
Page : 644 pages
File Size : 46,8 Mb
Release : 2023-03-27
Category : Computers
ISBN : 9780323903738

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A Handbook of Artificial Intelligence in Drug Delivery by Anil K. Philip,Aliasgar Shahiwala,Mamoon Rashid,Md Faiyazuddin Pdf

A Handbook of Artificial Intelligence in Drug Delivery explores the use of Artificial Intelligence (AI) in drug delivery strategies. The book covers pharmaceutical AI and drug discovery challenges, Artificial Intelligence tools for drug research, AI enabled intelligent drug delivery systems and next generation novel therapeutics, broad utility of AI for designing novel micro/nanosystems for drug delivery, AI driven personalized medicine and Gene therapy, 3D Organ printing and tissue engineering, Advanced nanosystems based on AI principles (nanorobots, nanomachines), opportunities and challenges using artificial intelligence in ADME/Tox in drug development, commercialization and regulatory perspectives, ethics in AI, and more. This book will be useful to academic and industrial researchers interested in drug delivery, chemical biology, computational chemistry, medicinal chemistry and bioinformatics. The massive time and costs investments in drug research and development necessitate application of more innovative techniques and smart strategies. Focuses on the use of Artificial Intelligence in drug delivery strategies and future impacts Provides insights into how artificial intelligence can be effectively used for the development of advanced drug delivery systems Written by experts in the field of advanced drug delivery systems and digital health

Author : Emil W. Ciurczak,Benoît Igne,Jerome Workman, Jr.,Donald A. Burns
Publisher : CRC Press
Page : 938 pages
File Size : 53,9 Mb
Release : 2021-05-19
Category : Science
ISBN : 9781351269872

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Handbook of Near-Infrared Analysis by Emil W. Ciurczak,Benoît Igne,Jerome Workman, Jr.,Donald A. Burns Pdf

Rapid, inexpensive, and easy-to-deploy, near-infrared (NIR) spectroscopy can be used to analyze samples of virtually any composition, origin, and condition. The Handbook of Near Infrared Analysis, Fourth Edition, explores the factors necessary to perform accurate and time- and cost-effective analyses across a growing spectrum of disciplines. This updated and expanded edition incorporates the latest advances in instrumentation, computerization, chemometrics applied to NIR spectroscopy, and method development in NIR spectroscopy, and underscores current trends in sample preparation, calibration transfer, process control, data analysis, instrument performance testing, and commercial NIR instrumentation. This work offers readers an unparalleled combination of theoretical foundations, cutting-edge applications, and practical experience. Additional features include the following: Explains how to perform accurate as well as time- and cost-effective analyses. Reviews software-enabled chemometric methods and other trends in data analysis. Highlights novel applications in pharmaceuticals, polymers, plastics, petrochemicals, textiles, foods and beverages, baked products, agricultural products, biomedicine, nutraceuticals, and counterfeit detection. Underscores current trends in sample preparation, calibration transfer, process control, data analysis, and multiple aspects of commercial NIR instrumentation. Offering the most complete single-source guide of its kind, the Handbook of Near Infrared Analysis, Fourth Edition, continues to offer practicing chemists and spectroscopists an unparalleled combination of theoretical foundations, cutting-edge applications, and detailed practical experience provided firsthand by more than 50 experts in the field.

Author : Christopher M. Riley,Thomas W. Rosanske
Publisher : Elsevier
Page : 349 pages
File Size : 54,8 Mb
Release : 1996-05-29
Category : Science
ISBN : 0080530354

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Development and Validation of Analytical Methods by Christopher M. Riley,Thomas W. Rosanske Pdf

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.

Author : James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell
Publisher : CRC Press
Page : 1062 pages
File Size : 47,6 Mb
Release : 2021-10-28
Category : Medical
ISBN : 9781000436013

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Handbook of Validation in Pharmaceutical Processes, Fourth Edition by James Agalloco,Phil DeSantis,Anthony Grilli,Anthony Pavell Pdf

Revised to reflect significant advances in pharmaceutical production and regulatory expectations, Handbook of Validation in Pharmaceutical Processes, Fourth Edition examines and blueprints every step of the validation process needed to remain compliant and competitive. This book blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded work is a comprehensive analysis of all the fundamental elements of pharmaceutical and bio-pharmaceutical production processes. Handbook of Validation in Pharmaceutical Processes, Fourth Edition is essential for all global health care manufacturers and pharmaceutical industry professionals. Key Features: Provides an in-depth discussion of recent advances in sterilization Identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions Explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results New chapters include disposable systems, combination products, nano-technology, rapid microbial methods, contamination control in non-sterile products, liquid chemical sterilization, and medical device manufacture