Pharmaceutical Quality by Design

Written By Walkiria S. Schlindwein
Pharmaceutical Quality by Design
  • Publsiher : John Wiley & Sons
  • Release : 19 March 2018
  • ISBN : 1118895207
  • Pages : 368 pages
  • Rating : 3/5 from 1 reviews
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Download or read book entitled Pharmaceutical Quality by Design by author: Walkiria S. Schlindwein which was release on 19 March 2018 and published by John Wiley & Sons with total page 368 pages . This book available in PDF, EPUB and Kindle Format. 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.

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher : John Wiley & Sons
  • Release Date : 2018-03-19
  • Total pages : 368
  • ISBN : 1118895207
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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 ...

Pharmaceutical Quality by Design Using JMP

Pharmaceutical Quality by Design Using JMP
  • Author : Rob Lievense
  • Publisher : SAS Institute
  • Release Date : 2018-10-03
  • Total pages : 436
  • ISBN : 1118895207
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Summary : Solve your pharmaceutical product development and manufacturing problems using JMP . Pharmaceutical Quality by Design Using JMP : Solving Product Development and Manufacturing Problems provides broad-based techniques available in JMP to visualize data and run statistical analyses for areas common in healthcare product manufacturing. As international regulatory agencies push the concept of ...

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis
  • Publisher : John Wiley & Sons
  • Release Date : 2017-10-09
  • Total pages : 416
  • ISBN : 1118895207
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Summary : This book is a structured approach to designing a product and its associated manufacturing process. It shows pharmaceutical engineers and scientists involved in product and process development how to utilize QbD practices and applications effectively while complying with government regulations. Material includes discussion of how to utilize design space, models, ...

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals
  • Author : Anurag S. Rathore,Rohin Mhatre
  • Publisher : John Wiley & Sons
  • Release Date : 2011-09-20
  • Total pages : 312
  • ISBN : 1118895207
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Summary : The concepts, applications, and practical issues of Quality byDesign Quality by Design (QbD) is a new framework currently beingimplemented by the FDA, as well as EU and Japanese regulatoryagencies, to ensure better understanding of the process so as toyield a consistent and high-quality pharmaceutical product. QbDbreaks from past approaches in ...

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain
  • Publisher : Academic Press
  • Release Date : 2019-03-27
  • Total pages : 448
  • ISBN : 1118895207
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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 ...

Process Monitoring and Quality by Design for Biotechnology Products

Process Monitoring and Quality by Design for Biotechnology Products
  • Author : Neslihan Delacruz
  • Publisher : Morgan & Claypool Publishers
  • Release Date : 2010-10-31
  • Total pages : 100
  • ISBN : 1118895207
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Summary : Traditional pharmaceutical development is an unwieldy process requiring extensive experimentation and long lead times before process scientists can fully understand the effect that process parameters such as pH, temperature, cell viability, or process yield may have on the product acceptability. Implementation of quality by design is a science-based approach that ...

Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher : Academic Press
  • Release Date : 2021-01-09
  • Total pages : 222
  • ISBN : 1118895207
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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 ...

Computer aided applications in pharmaceutical technology

Computer aided applications in pharmaceutical technology
  • Author : Jelena Djuris,Svetlana Ibric,Zorica Djuric
  • Publisher : Elsevier Inc. Chapters
  • Release Date : 2013-04-10
  • Total pages : 300
  • ISBN : 1118895207
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Summary : This first chapter introduces the concept of quality-by-design (QbD) and its role in pharmaceutical product development. QbD assures the quality of a pharmaceutical product through scientific development and risk management tools, and will eventually enable real-time release, regardless of the formulation type. Several guidelines on pharmaceutical development, quality risk management, ...

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
  • Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
  • Publisher : Springer
  • Release Date : 2015-04-01
  • Total pages : 710
  • ISBN : 1118895207
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Summary : 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 ...

Pharmaceutical Quality by Design

Pharmaceutical Quality by Design
  • Author : Walkiria S. Schlindwein,Mark Gibson
  • Publisher : Unknown
  • Release Date : 2018
  • Total pages : 368
  • ISBN : 1118895207
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Summary : Includes several illustrative examples of applications, this book outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. --...

Pharmaceutical Drug Product Development and Process Optimization

Pharmaceutical Drug Product Development and Process Optimization
  • Author : Sarwar Beg,Majed Al Robaian,Mahfoozur Rahman,Syed Sarim Imam,Nabil Alruwaili,Sunil Kumar Panda
  • Publisher : CRC Press
  • Release Date : 2020-05-01
  • Total pages : 354
  • ISBN : 1118895207
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Summary : Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the ...

Quality by Design Model for Biologics Drug Product Development

Quality by Design Model for Biologics Drug Product Development
  • Author : Satish K. Singh,Joseph Phillips
  • Publisher : Wiley
  • Release Date : 2015-04
  • Total pages : 300
  • ISBN : 1118895207
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Summary : A set of case studies on the different aspects of biologics drug product manufacturing, the book aims to help design manufacturing processes that meet the specific quality attributes of a product. Testing should be used to confirm the quality of the product, not to find out whether it met quality ...

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture

Comprehensive Quality by Design in Pharmaceutical Development and Manufacture
  • Author : American Institute of Chemical Engineers
  • Publisher : Unknown
  • Release Date : 2011
  • Total pages : 212
  • ISBN : 1118895207
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Summary : Read online Comprehensive Quality by Design in Pharmaceutical Development and Manufacture written by American Institute of Chemical Engineers, published by which was released on 2011. Download full Comprehensive Quality by Design in Pharmaceutical Development and Manufacture Books now! Available in PDF, ePub and Kindle....

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
  • Author : Sarwar Beg
  • Publisher : Springer Nature
  • Release Date : 2021-01-22
  • Total pages : 188
  • ISBN : 1118895207
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Summary : This book volume provides complete and updated information on the applications of Design of Experiments (DoE) and related multivariate techniques at various stages of pharmaceutical product development. It discusses the applications of experimental designs that shall include oral, topical, transdermal, injectables preparations, and beyond for nanopharmaceutical product development, leading to ...

Quality by Design and Process Analytical Technologies

Quality by Design and Process Analytical Technologies
  • Author : Greg McGurk
  • Publisher : Unknown
  • Release Date : 2008
  • Total pages : 212
  • ISBN : 1118895207
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Summary : Read online Quality by Design and Process Analytical Technologies written by Greg McGurk, published by which was released on 2008. Download full Quality by Design and Process Analytical Technologies Books now! Available in PDF, ePub and Kindle....