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
GET THIS BOOKHow to Integrate Quality by Efficient Design QbED in Product Development


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
GET BOOK

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
GET BOOK

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
GET BOOK

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
GET BOOK

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
GET BOOK

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 ...

Design of Experiments for Pharmaceutical Product Development

Design of Experiments for Pharmaceutical Product Development
  • Author : Sarwar Beg
  • Publisher : Springer Nature
  • Release Date : 2021-01-12
  • Total pages : 96
  • ISBN : 0128173041
GET BOOK

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 ...

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
GET BOOK

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, ...

Research Anthology on Big Data Analytics Architectures and Applications

Research Anthology on Big Data Analytics  Architectures  and Applications
  • Author : Management Association, Information Resources
  • Publisher : IGI Global
  • Release Date : 2021-09-24
  • Total pages : 1988
  • ISBN : 0128173041
GET BOOK

Summary : Society is now completely driven by data with many industries relying on data to conduct business or basic functions within the organization. With the efficiencies that big data bring to all institutions, data is continuously being collected and analyzed. However, data sets may be too complex for traditional data-processing, and ...

Setting the PACE in Product Development

Setting the PACE in Product Development
  • Author : Michael E. McGrath
  • Publisher : Routledge
  • Release Date : 1996
  • Total pages : 184
  • ISBN : 0128173041
GET BOOK

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 ...

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 : 0128173041
GET BOOK

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 ...

Thermoplastics and Thermoplastic Composites

Thermoplastics and Thermoplastic Composites
  • Author : Michel Biron
  • Publisher : William Andrew
  • Release Date : 2018-06-06
  • Total pages : 1164
  • ISBN : 0128173041
GET BOOK

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 ...

Textile Technology Digest

Textile Technology Digest
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1999
  • Total pages : 212
  • ISBN : 0128173041
GET BOOK

Summary : Download or read online Textile Technology Digest written by , published by which was released on 1999. Get Textile Technology Digest Books now! Available in PDF, ePub and Kindle....

Quality Strategy for Research and Development

Quality Strategy for Research and Development
  • Author : Ming-Li Shiu,Jui-Chin Jiang,Mao-Hsiung Tu
  • Publisher : John Wiley & Sons
  • Release Date : 2013-06-19
  • Total pages : 384
  • ISBN : 0128173041
GET BOOK

Summary : Provides a clear, useful framework and methods for R&D,including robust technology development, product planning, andproduct design and development management Quality Strategy for Research and Development integratesthe Japanese and Western perspectives on Quality FunctionDeployment (QFD), updates the strategy of Robust Engineering (RE),and relates their unique frameworks to current, ...

Miscellaneous Publication

Miscellaneous Publication
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1981
  • Total pages : 207
  • ISBN : 0128173041
GET BOOK

Summary : Download or read online Miscellaneous Publication written by , published by which was released on 1981. Get Miscellaneous Publication Books now! Available in PDF, ePub and Kindle....