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

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 ...

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 ...

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 ...

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Author : Gintaras V. Reklaitis,Christine Seymour,Salvador GarcĂ­a-Munoz
  • Publisher : John Wiley & Sons
  • Release Date : 2017-09-01
  • Total pages : 416
  • ISBN : 1118895207
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Summary : 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 ...

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 ...

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 ...

Introduction to Quality by Design for Pharmaceuticals

Introduction to Quality by Design for Pharmaceuticals
  • Author : Nilesh Desai,Manohar A Potdar
  • Publisher : Pharmamed Press
  • Release Date : 2017-10-03
  • Total pages : 192
  • ISBN : 1118895207
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Summary : Quality by design (QbD) is extensively used tool in formulation and development. QbD is a method of choice in product development for robust and quality product incorporating continuous improvement. The objective of the book is to study the implementation of QbD and wide-ranging QbD based product development template for different ...

The Quality by Design Handbook

The Quality by Design Handbook
  • Author : Christopher Herwig,Jose C. Menezes
  • Publisher : Unknown
  • Release Date : 2013-10-01
  • Total pages : 450
  • ISBN : 1118895207
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Summary : A one-stop, definitive resource for readers who need to know what quality by design, or QbD, is, its origins and shortcomings, the connection with continuous improvement, and, most importantly, how to apply it in practice in the pharma and biopharma sectors....

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 ...

Method Validation in Pharmaceutical Analysis

Method Validation in Pharmaceutical Analysis
  • Author : Joachim Ermer,Phil W. Nethercote
  • Publisher : John Wiley & Sons
  • Release Date : 2014-10-27
  • Total pages : 440
  • ISBN : 1118895207
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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 ...

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 ...

Product Realization Using Quality by Design QbD

Product Realization Using Quality by Design  QbD
  • Author : International Society for Pharmaceutical Engineering
  • Publisher : Unknown
  • Release Date : 2011
  • Total pages : 228
  • ISBN : 1118895207
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Summary : Read online Product Realization Using Quality by Design QbD written by International Society for Pharmaceutical Engineering, published by which was released on 2011. Download full Product Realization Using Quality by Design QbD Books now! Available in PDF, ePub and Kindle....

Polymorphism in the Pharmaceutical Industry

Polymorphism in the Pharmaceutical Industry
  • Author : Rolf Hilfiker,Markus von Raumer
  • Publisher : John Wiley & Sons
  • Release Date : 2019-04-29
  • Total pages : 512
  • ISBN : 1118895207
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Summary : "Polymorphism in the Pharmaceutical Industry - Solid Form and Drug Development" highlights the relevance of polymorphism in modern pharmaceutical chemistry, with a focus on quality by design (QbD) concepts. It covers all important issues by way of case studies, ranging from properties and crystallization, via thermodynamics, analytics and theoretical modelling ...

Handbook of Pharmaceutical Wet Granulation

Handbook of Pharmaceutical Wet Granulation
  • Author : Ajit S. Narang,Sherif I.F. Badawy
  • Publisher : Academic Press
  • Release Date : 2018-08-31
  • Total pages : 890
  • ISBN : 1118895207
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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 ...