Analytical Scientists In Pharmaceutical Product Development

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Analytical Scientists in Pharmaceutical Product Development

Author : Kangping Xiao
Publisher : John Wiley & Sons
ISBN 13 : 1119547822
Total Pages : 272 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Analytical Scientists in Pharmaceutical Product Development by : Kangping Xiao

Download or read book Analytical Scientists in Pharmaceutical Product Development written by Kangping Xiao and published by John Wiley & Sons. This book was released on 2020-10-06 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Handbook of Analytical Quality by Design

Author : Sarwar Beg
Publisher : Academic Press
ISBN 13 : 0128203331
Total Pages : 225 pages
Book Rating : 4.1/5 (282 download)

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Book Synopsis Handbook of Analytical Quality by Design by : Sarwar Beg

Download or read book Handbook of Analytical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2021-01-09 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Analytical Scientists in Pharmaceutical Product Development

Author : Kangping Xiao
Publisher : John Wiley & Sons
ISBN 13 : 1119547857
Total Pages : 272 pages
Book Rating : 4.1/5 (195 download)

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Book Synopsis Analytical Scientists in Pharmaceutical Product Development by : Kangping Xiao

Inhaled Pharmaceutical Product Development Perspectives

Author : Anthony J. Hickey
Publisher : Elsevier
ISBN 13 : 0128123362
Total Pages : 110 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Inhaled Pharmaceutical Product Development Perspectives by : Anthony J. Hickey

Download or read book Inhaled Pharmaceutical Product Development Perspectives written by Anthony J. Hickey and published by Elsevier. This book was released on 2017-11-23 with total page 110 pages. Available in PDF, EPUB and Kindle. Book excerpt: Inhaled Pharmaceutical Product Development Perspectives: Challenges and Opportunities describes methods and procedures for consideration when developing inhaled pharmaceuticals, while commenting on product development strategies and their suitability to support regulatory submission. It bridges the gap between the aspirations of scientists invested in new technology development and the requirements that must be met for any new product. The book brings together emerging analytical and inhalation technologies, providing perspectives that illuminate formulation and device design, development, regulatory compliance, and practice. Focusing on underlying scientific and technical principles known to be acceptable from the current regulatory perspective, this monograph will remain useful as a high-level guide to inhaled product development for the foreseeable future. Discusses development strategies and best practices in the context of regulatory requirements Written by a broadly qualified expert drawing on the knowledge and critical opinions of key individuals in the field Includes a foreword by Charles G. Thiel

Formulation and Analytical Development for Low-Dose Oral Drug Products

Author : Jack Zheng
Publisher : John Wiley & Sons
ISBN 13 : 0470056096
Total Pages : 506 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis Formulation and Analytical Development for Low-Dose Oral Drug Products by : Jack Zheng

Download or read book Formulation and Analytical Development for Low-Dose Oral Drug Products written by Jack Zheng and published by John Wiley & Sons. This book was released on 2009-02-09 with total page 506 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
ISBN 13 : 0470942371
Total Pages : 418 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-10-09 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products

Author : M.M.W.B. Hendriks
Publisher : Elsevier
ISBN 13 : 0080540635
Total Pages : 361 pages
Book Rating : 4.0/5 (85 download)

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Book Synopsis Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products by : M.M.W.B. Hendriks

Download or read book Robustness of Analytical Chemical Methods and Pharmaceutical Technological Products written by M.M.W.B. Hendriks and published by Elsevier. This book was released on 1996-12-11 with total page 361 pages. Available in PDF, EPUB and Kindle. Book excerpt: In analytical chemistry and pharmaceutical technology attention is increasingly focussed on improving the quality of methods and products. This book aims at fostering the awareness of the potential of existing mathematical and statistical methods to improve this quality. It provides procedures and ideas on how to make a product or a method less sensitive to small variations in influencing factors. Major issues covered are robustness and stability improvement and ruggedness testing. General strategies and a theoretical introduction to these methods are described, and thorough overviews of methods used in both application areas and descriptions of practical applications are given. Features of this book: • Gives a good overview of mathematical and statistical methods used in two application areas, i.e. pharmaceutical technology and analytical chemistry • Illustrates the different approaches available to attain robustness • Gives ideas on how to use methods in practical situations. The book is intended for those who develop and optimize, and are responsible for the overall quality of, analytical methods and pharmaceutical technological products and procedures.

Formulation and Analytical Development for Low-Dose Oral Drug Products

Author : Jack Zheng
Publisher : John Wiley & Sons
ISBN 13 : 0470386355
Total Pages : 492 pages
Book Rating : 4.4/5 (73 download)

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Book Synopsis Formulation and Analytical Development for Low-Dose Oral Drug Products by : Jack Zheng

Download or read book Formulation and Analytical Development for Low-Dose Oral Drug Products written by Jack Zheng and published by John Wiley & Sons. This book was released on 2009-03-04 with total page 492 pages. Available in PDF, EPUB and Kindle. Book excerpt: There are unique challenges in the formulation, manufacture, analytical chemistry, and regulatory requirements of low-dose drugs. This book provides an overview of this specialized field and combines formulation, analytical, and regulatory aspects of low-dose development into a single reference book. It describes analytical methodologies like dissolution testing, solid state NMR, Raman microscopy, and LC-MS and presents manufacturing techniques such as granulation, compaction, and compression. Complete with case studies and a discussion of regulatory requirements, this is a core reference for pharmaceutical scientists, regulators, and graduate students.

Pharmaceutical Product Development

Author : Vandana B. Patravale
Publisher : CRC Press
ISBN 13 : 1498730787
Total Pages : 438 pages
Book Rating : 4.4/5 (987 download)

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Book Synopsis Pharmaceutical Product Development by : Vandana B. Patravale

Download or read book Pharmaceutical Product Development written by Vandana B. Patravale and published by CRC Press. This book was released on 2016-05-25 with total page 438 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive

Pharmaceutical Analysis for Small Molecules

Author : Behnam Davani
Publisher : John Wiley & Sons
ISBN 13 : 1119425034
Total Pages : 258 pages
Book Rating : 4.1/5 (194 download)

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Book Synopsis Pharmaceutical Analysis for Small Molecules by : Behnam Davani

Download or read book Pharmaceutical Analysis for Small Molecules written by Behnam Davani and published by John Wiley & Sons. This book was released on 2017-07-12 with total page 258 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive introduction for scientists engaged in new drug development, analysis, and approvals Each year the pharmaceutical industry worldwide recruits thousands of recent science graduates—especially chemistry, analytical chemistry, pharmacy, and pharmaceutical majors—into its ranks. However, because of their limited background in pharmaceutical analysis most of those new recruits find making the transition from academia to industry very difficult. Designed to assist both recent graduates, as well as experienced chemists or scientists with limited regulatory, compendial or pharmaceutical analysis background, make that transition, Pharmaceutical Analysis for Small Molecules is a concise, yet comprehensive introduction to the drug development process and analysis of chemically synthesized, small molecule drugs. It features contributions by distinguished experts in the field, including editor and author, Dr. Behnam Davani, an analytical chemist with decades of technical management and teaching experience in compendial, regulatory, and industry. This book provides an introduction to pharmaceutical analysis for small molecules (non-biologics) using commonly used techniques for drug characterization and performance tests. The driving force for industry to perform pharmaceutical analyses is submission of such data and supporting documents to regulatory bodies for drug approval in order to market their products. In addition, related required supporting studies including good laboratory/documentation practices including analytical instrument qualification are highlighted in this book. Topics covered include: Drug Approval Process and Regulatory Requirements (private standards) Pharmacopeias and Compendial Approval Process (public standards) Common methods in pharmaceutical analysis (typically compendial) Common Calculations for assays and impurities and other specific tests Analytical Method Validation, Verification, Transfer Specifications including how to handle out of specification (OOS) and out of trend (OOT) Impurities including organic, inorganic, residual solvents and elemental impurities Good Documentation Practices for regulatory environment Management of Analytical Laboratories Analytical Instrument Qualifications including IQ, OQ, PQ and VQ Due to global nature of pharmaceutical industry, other topics on both regulatory (ICH) and Compendial harmonization are also highlighted. Pharmaceutical Analysis for Small Molecules is a valuable working resource for scientists directly or indirectly involved with the drug development process, including analytical chemists, pharmaceutical scientists, pharmacists, and quality control/quality assurance professionals. It also is an excellent text/reference for graduate students in analytical chemistry, pharmacy, pharmaceutical and regulatory sciences.

HPLC for Pharmaceutical Scientists

Author : Yuri V. Kazakevich
Publisher : John Wiley & Sons
ISBN 13 : 0470087943
Total Pages : 1136 pages
Book Rating : 4.4/5 (7 download)

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Book Synopsis HPLC for Pharmaceutical Scientists by : Yuri V. Kazakevich

Download or read book HPLC for Pharmaceutical Scientists written by Yuri V. Kazakevich and published by John Wiley & Sons. This book was released on 2007-02-16 with total page 1136 pages. Available in PDF, EPUB and Kindle. Book excerpt: HPLC for Pharmaceutical Scientists is an excellent book for both novice and experienced pharmaceutical chemists who regularly use HPLC as an analytical tool to solve challenging problems in the pharmaceutical industry. It provides a unified approach to HPLC with an equal and balanced treatment of the theory and practice of HPLC in the pharmaceutical industry. In-depth discussion of retention processes, modern HPLC separation theory, properties of stationary phases and columns are well blended with the practical aspects of fast and effective method development and method validation. Practical and pragmatic approaches and actual examples of effective development of selective and rugged HPLC methods from a physico-chemical point of view are provided. This book elucidates the role of HPLC throughout the entire drug development process from drug candidate inception to marketed drug product and gives detailed specifics of HPLC application in each stage of drug development. The latest advancements and trends in hyphenated and specialized HPLC techniques (LC-MS, LC-NMR, Preparative HPLC, High temperature HPLC, high pressure liquid chromatography) are also discussed.

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Author : Gintaras V. Reklaitis
Publisher : John Wiley & Sons
ISBN 13 : 1119356164
Total Pages : 420 pages
Book Rating : 4.1/5 (193 download)

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Book Synopsis Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by : Gintaras V. Reklaitis

Download or read book Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture written by Gintaras V. Reklaitis and published by John Wiley & Sons. This book was released on 2017-08-30 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Covers a widespread view of Quality by Design (QbD) encompassing the many stages involved in the development of a new drug product. The book provides a broad view of Quality by Design (QbD) and shows how QbD concepts and analysis facilitate the development and manufacture of high quality products. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processes The role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process.

Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design

Author : Suryakanta Swain
Publisher : Cambridge Scholars Publishing
ISBN 13 : 1036402576
Total Pages : 162 pages
Book Rating : 4.0/5 (364 download)

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Book Synopsis Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design by : Suryakanta Swain

Download or read book Green Chemistry and Quality by Design in Process Analytical Technologies and Drug Design written by Suryakanta Swain and published by Cambridge Scholars Publishing. This book was released on 2024-04-10 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality by design (QbD) is becoming an integral element of the modern pharmaceutical and chemical development approach. In this book, the future ramifications of emergent modern applications of QbD and green analytical chemistry in drug design, process analytical technologies, and bioanalytical process development instruments are discussed. It will reveal and improve the QbD principles used in bioanalysis, process development, downstream processing, and the combination of QbD and green analytical chemistry employing eco-friendly and green solvents for product development. In addition, it will provide complete information regarding applying the QbD concept and ideology to quality control and process development. The book will be beneficial to PhD research scholars, researchers, and postgraduate and undergraduate students of pharmacy and chemical sciences for understanding the concept of quality by design and green chemistry for drug design, as it illustrates the necessary inputs that are related to product quality and, ultimately, process sustainability.

Handbook of Pharmaceutical Analysis

Author : Lena Ohannesian
Publisher : CRC Press
ISBN 13 : 0824741943
Total Pages : 605 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Handbook of Pharmaceutical Analysis by : Lena Ohannesian

Download or read book Handbook of Pharmaceutical Analysis written by Lena Ohannesian and published by CRC Press. This book was released on 2001-11-09 with total page 605 pages. Available in PDF, EPUB and Kindle. Book excerpt: Exploring the analysis of pharmaceuticals, including polymorphic forms, this book discusses regulatory requirements in pharmaceutical product development and pharmaceutical testing. It covers methods of drug separation and procedures such as capillary electrophoresis for chromatographic separation of molecules. Additional topics include drug formulation analysis using vibrational and magnetic resonance spectroscopy and identification of drug metabolites and decomposition products using such techniques as mass spectrometry. The book provides more than 300 tables, equations, drawings, and photographs, and convenient, easy-to-use indices, facilitating quick access to each topic.

Pharmaceutical Analysis

Author : David C Lee
Publisher : John Wiley & Sons
ISBN 13 : 1405172991
Total Pages : 384 pages
Book Rating : 4.4/5 (51 download)

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Book Synopsis Pharmaceutical Analysis by : David C Lee

Download or read book Pharmaceutical Analysis written by David C Lee and published by John Wiley & Sons. This book was released on 2009-02-12 with total page 384 pages. Available in PDF, EPUB and Kindle. Book excerpt: The use of analytical sciences in the discovery, development andmanufacture of pharmaceuticals is wide-ranging. From the analysisof minute amounts of complex biological materials to the qualitycontrol of the final dosage form, the use of analytical technologycovers an immense range of techniques and disciplines. This book concentrates on the analytical aspects of drugdevelopment and manufacture, focusing on the analysis of the activeingredient or drug substance. It provides those joining theindustry or other areas of pharmaceutical research with a source ofreference to a broad range of techniques and their applications,allowing them to choose the most appropriate analytical techniquefor a particular purpose. The volume is directed at analytical chemists, industrialpharmacists, organic chemists, pharmaceutical chemists andbiochemists.

Analytical Testing for the Pharmaceutical GMP Laboratory

Author : Kim Huynh-Ba
Publisher : John Wiley & Sons
ISBN 13 : 1119680433
Total Pages : 420 pages
Book Rating : 4.1/5 (196 download)

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Book Synopsis Analytical Testing for the Pharmaceutical GMP Laboratory by : Kim Huynh-Ba

Download or read book Analytical Testing for the Pharmaceutical GMP Laboratory written by Kim Huynh-Ba and published by John Wiley & Sons. This book was released on 2022-03-31 with total page 420 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides practical guidance on pharmaceutical analysis, written by leading experts with extensive industry experience Analytical Testing for the Pharmaceutical GMP Laboratory presents a thorough overview of the pharmaceutical regulations, working processes, and drug development best practices used to maintain the quality and integrity of medicines. With a focus on smaller molecular weight drug substances and products, the book provides the knowledge necessary for establishing the pharmaceutical laboratory to support Quality Systems while maintaining compliance with Good Manufacturing Practices (GMP) regulations. Concise yet comprehensive chapters contain up-to-date coverage of drug regulations, pharmaceutical analysis methodologies, control strategies, testing development and validation, method transfer, electronic data documentation, and more. Each chapter includes a table of contents, definitions of acronyms, a reference list, and ample tables and figures. Addressing the principal activities and regulatory challenges of analytical testing in the development and manufacturing of pharmaceutical drug products, this authoritative resource: Describes the structure, roles, core guidelines, and GMP regulations of the FDA and ICH. Covers the common analytical technologies used in pharmaceutical laboratories, including examples of analytical techniques used for the release and stability testing of drugs. Examines control strategies established from quality systems supported by real-world case studies. Explains the use of dissolution testing for products such as extended-release capsules, aerosols, and inhalers. Discusses good documentation and data reporting practices, stability programs, and the Laboratory Information Management System (LIMS) to maintain compliance. Includes calculations, application examples, and illustrations to assist readers in day-to-day laboratory operations. Contains practical information and templates to structure internal processes or common Standard Operating Procedures (SOPs). Analytical Testing for the Pharmaceutical GMP Laboratory is a must-have reference for both early-career and experienced pharmaceutical scientists, analytical chemists, pharmacists, and quality control professionals. It is also both a resource for GMP laboratory training programs and an excellent textbook for undergraduate and graduate courses of analytical chemistry in pharmaceutical sciences or regulatory compliance programs.

Pharmaceutical Quality by Design

Author : Walkiria S. Schlindwein
Publisher : John Wiley & Sons
ISBN 13 : 1118895223
Total Pages : 368 pages
Book Rating : 4.1/5 (188 download)

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Book Synopsis Pharmaceutical Quality by Design by : Walkiria S. Schlindwein

Download or read book Pharmaceutical Quality by Design written by Walkiria S. Schlindwein and published by John Wiley & Sons. This book was released on 2018-01-11 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.