How to Integrate Quality by Efficient Design QbED in Product Development

Written By Bhavishya Mittal
How to Integrate Quality by Efficient Design  QbED  in Product Development
  • Publsiher : Academic Press
  • Release : 24 August 2019
  • ISBN : 0128173041
  • Pages : 274 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled How to Integrate Quality by Efficient Design QbED in Product Development written by Bhavishya Mittal which was release on 24 August 2019, this book published by Academic Press. Available in PDF, EPUB and Kindle Format. Book excerpt: The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development
  • Author : Bhavishya Mittal
  • Publisher : Academic Press
  • Release Date : 2019-08-24
  • Total pages : 274
  • ISBN : 0128173041
GET BOOK

Summary : The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical ...

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 : 0128173041
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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 ...

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
  • Author : Igor Gorsky,Harold S. Baseman
  • Publisher : Academic Press
  • Release Date : 2019-04-15
  • Total pages : 208
  • ISBN : 0128173041
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Summary : Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the ...

Design for Six Sigma

Design for Six Sigma
  • Author : Elizabeth A. Cudney,Tina Kanti Agustiady
  • Publisher : CRC Press
  • Release Date : 2016-08-05
  • Total pages : 357
  • ISBN : 0128173041
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Summary : Design for Six Sigma (DFSS) is an innovative continuous improvement methodology for designing new products, processes, and services by integrating Lean and Six Sigma principles. This book will explain how the DFSS methodology is used to design robust products, processes, or services right the first time by using the voice ...

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms
  • Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lawrence Yu,Rao V. Mantri
  • Publisher : Academic Press
  • Release Date : 2016-11-08
  • Total pages : 1176
  • ISBN : 0128173041
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Summary : Developing Solid Oral Dosage Forms: Pharmaceutical Theory and Practice, Second Edition illustrates how to develop high-quality, safe, and effective pharmaceutical products by discussing the latest techniques, tools, and scientific advances in preformulation investigation, formulation, process design, characterization, scale-up, and production operations. This book covers the essential principles of physical pharmacy, ...

Revolutionizing Product Development

Revolutionizing Product Development
  • Author : Steven C. Wheelwright,Kim B. Clark
  • Publisher : Simon and Schuster
  • Release Date : 1992-06-15
  • Total pages : 364
  • ISBN : 0128173041
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Summary : Today, a company's capability to conceive and design quality prototypes and bring a variety of superior products to market quicker than its competitors is increasingly the focal point of competition, contend leading product development experts Steven Wheelwright and Kim Clark. Drawing on six years of in-depth, systematic, worldwide research, they ...

Formulation and Analytical Development for Low Dose Oral Drug Products

Formulation and Analytical Development for Low Dose Oral Drug Products
  • Author : Jack Zheng
  • Publisher : John Wiley & Sons
  • Release Date : 2009-02-09
  • Total pages : 496
  • ISBN : 0128173041
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Summary : 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, ...

Setting the PACE in Product Development

Setting the PACE in Product Development
  • Author : Michael E. McGrath
  • Publisher : Routledge
  • Release Date : 2012-06-14
  • Total pages : 240
  • ISBN : 0128173041
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Summary : Setting the PACE in Product Development describes how to effectively manage the key ingredients of successful product development: time, quality, talent and resources. This revised edition of Product Development provides essential insight as to how to efficiently organize people, resources and processes to dramatically improve financial results, strategic positions, internal ...

Integrated Computer Aided Design in Automotive Development

Integrated Computer Aided Design in Automotive Development
  • Author : Hirz Mario,Wilhelm Dietrich,Anton Gfrerrer,Johann Lang
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-06-22
  • Total pages : 466
  • ISBN : 0128173041
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Summary : The automotive industry faces constant pressure to reduce development costs and time while still increasing vehicle quality. To meet this challenge, engineers and researchers in both science and industry are developing effective strategies and flexible tools by enhancing and further integrating powerful, computer-aided design technology. This book provides a valuable ...

Food Product Design

Food Product Design
  • Author : Anita R. Linnemann,Catharina Gerarda Petronella Henrica Schroën,M. A. J. S. van Boekel
  • Publisher : Wageningen Academic Pub
  • Release Date : 2011
  • Total pages : 283
  • ISBN : 0128173041
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Summary : 'Food product design - An integrated approach' deals with food product design from a technological perspective. It presents creative techniques for the innovation process and structured methodologies to translate consumer wishes into product properties based on Quality Function Deployment. Up-to-date solutions for chemical and physical changes during food processing and ...

Thermoplastics and Thermoplastic Composites

Thermoplastics and Thermoplastic Composites
  • Author : Michel Biron
  • Publisher : William Andrew
  • Release Date : 2018-06-06
  • Total pages : 1164
  • ISBN : 0128173041
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Summary : Thermoplastics and Thermoplastic Composites, Third Edition bridges the technology and business aspects of thermoplastics, providing a guide designed to help engineers working in real-world industrial settings. The author explores the criteria for material selection, provides a detailed guide to each family of thermoplastics, and explains the various processing options for ...

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 : 0128173041
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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, ...

Improvement of Buildings Structural Quality by New Technologies

Improvement of Buildings  Structural Quality by New Technologies
  • Author : Christian Schauer,ENG. Federico Mazzolani,Gerald Huber,Gianfranco de Matteis,Heiko Trumpf,Heli Koukkari,Jean-Pierre Jaspart,Luis Bragança
  • Publisher : CRC Press
  • Release Date : 2005-01-20
  • Total pages : 624
  • ISBN : 0128173041
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Summary : Launched in May 2000, the aims of the COST C12 cooperative action were: to develop, combine and disseminate new technical engineering technologies to improve the quality of urban buildings to propose new technical solutions to architects and planners to reduce the disturbance caused by construction in urban areas and improve urban ...

Textile Technology Digest

Textile Technology Digest
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2000
  • Total pages : 212
  • ISBN : 0128173041
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Summary : Download or read online Textile Technology Digest written by , published by which was released on 2000. Get Textile Technology Digest Books now! Available in PDF, ePub and Kindle....

Dosage Form Design Considerations

Dosage Form Design Considerations
  • Author : Anonim
  • Publisher : Academic Press
  • Release Date : 2018-07-28
  • Total pages : 820
  • ISBN : 0128173041
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Summary : Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in ...