Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture

Written By Gintaras V. Reklaitis
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
  • Publsiher : John Wiley & Sons
  • Release : 09 October 2017
  • ISBN : 0470942371
  • Pages : 416 pages
  • Rating : /5 from reviews
GET THIS BOOKComprehensive Quality by Design for Pharmaceutical Product Development and Manufacture


Download or read book entitled Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture by author: Gintaras V. Reklaitis which was release on 09 October 2017 and published by John Wiley & Sons with total page 416 pages . This book available in PDF, EPUB and Kindle Format. 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, process control methodology, and cumulative process knowledge to seek improvements in manufacturing, while maintaining and enhancing product performance. Edited by three renowned researchers in the field, this invaluable resource is an essential tool for all pharmaceutical professionals.

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 : 0470942371
GET BOOK

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, ...

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 García-Munoz
  • Publisher : John Wiley & Sons
  • Release Date : 2017-08-30
  • Total pages : 416
  • ISBN : 0470942371
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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 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 : 0470942371
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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 ...

Continuous Manufacturing of Pharmaceuticals

Continuous Manufacturing of Pharmaceuticals
  • Author : Peter Kleinebudde,Johannes Khinast,Jukka Rantanen
  • Publisher : John Wiley & Sons
  • Release Date : 2017-09-05
  • Total pages : 620
  • ISBN : 0470942371
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Summary : 10.7.3 State of Control...

Integrated Pharmaceutics

Integrated Pharmaceutics
  • Author : Antoine Al-Achi,Mali Ram Gupta,William Craig Stagner
  • Publisher : John Wiley & Sons
  • Release Date : 2013-01-22
  • Total pages : 1016
  • ISBN : 0470942371
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Summary : Focusing on the application of physical pharmacy, drug design, and drug regulations as they relate to produce effective dosage forms for drug delivery, Integrated Pharmaceutics provides a comprehensive picture of pharmaceutical product design, describing the science and art behind the concepts of dosage form development. Combining physical pharmacy, product design, ...

Thomas Register of American Manufacturers and Thomas Register Catalog File

Thomas Register of American Manufacturers and Thomas Register Catalog File
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2003
  • Total pages : 212
  • ISBN : 0470942371
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Summary : Vols. for 1970-71 includes manufacturers' catalogs....

Medical and Health Information Directory

Medical and Health Information Directory
  • Author : Gale Group
  • Publisher : Gale Cengage
  • Release Date : 2002-12
  • Total pages : 212
  • ISBN : 0470942371
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Summary : Read online Medical and Health Information Directory written by Gale Group, published by Gale Cengage which was released on 2002-12. Download full Medical and Health Information Directory Books now! Available in PDF, ePub and Kindle....

Thomas Register of American Manufacturers

Thomas Register of American Manufacturers
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2002
  • Total pages : 212
  • ISBN : 0470942371
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Summary : This basic source for identification of U.S. manufacturers is arranged by product in a large multi-volume set. Includes: Products & services, Company profiles and Catalog file....

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 : 0470942371
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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, ...

Good Manufacturing Practices for Pharmaceuticals

Good Manufacturing Practices for Pharmaceuticals
  • Author : Sidney H. Willig,James R. Stoker
  • Publisher : Unknown
  • Release Date : 1997
  • Total pages : 496
  • ISBN : 0470942371
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Summary : Revised to ensure GMP compliance, this text examines US laws affecting domestic and multinational pharmaceutical manufacturing. It recommends practical ways to interpret and comply with FDA CGMP regulations while meeting the goals of a comprehensive controls system to preserve product integrity....

Emerging Non Clinical Biostatistics in Biopharmaceutical Development and Manufacturing

Emerging Non Clinical Biostatistics in Biopharmaceutical Development and Manufacturing
  • Author : Harry Yang
  • Publisher : CRC Press
  • Release Date : 2016-11-30
  • Total pages : 386
  • ISBN : 0470942371
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Summary : The premise of Quality by Design (QbD) is that the quality of the pharmaceutical product should be based upon a thorough understanding of both the product and the manufacturing process. This state-of-the-art book provides a single source of information on emerging statistical approaches to QbD and risk-based pharmaceutical development. A ...

Mechanical Engineering

Mechanical Engineering
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1964
  • Total pages : 212
  • ISBN : 0470942371
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Summary : Read online Mechanical Engineering written by , published by which was released on 1964. Download full Mechanical Engineering Books now! Available in PDF, ePub and Kindle....

Formulation Design and Evaluation of Amorphous and Crystalline Nanoparticles of BCS Class II and II IV Drugs

Formulation Design and Evaluation of Amorphous and Crystalline Nanoparticles of BCS Class II and II IV Drugs
  • Author : Rajan Jog
  • Publisher : Unknown
  • Release Date : 2018
  • Total pages : 227
  • ISBN : 0470942371
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Summary : In the last few decades, the pharmaceutical industry has employed a quality by design (QbD) approach for conventional drug product development to minimize errors in product optimization and validation. Lately, this has been extended to novel pharmaceutical drug products (such as nanocrystalline and nanoamorphous drug products). The present research emphasizes ...

Machine Design

Machine Design
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1998
  • Total pages : 212
  • ISBN : 0470942371
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Summary : Read online Machine Design written by , published by which was released on 1998. Download full Machine Design Books now! Available in PDF, ePub and Kindle....

The Entrepreneurial Engineer

The Entrepreneurial Engineer
  • Author : R. Wayne Fields
  • Publisher : Artech House Publishers
  • Release Date : 1999
  • Total pages : 332
  • ISBN : 0470942371
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Summary : Skilled engineers or managers with creative product ideas but limited knowledge of how to actually start building a company around their ideas can benefit from this invaluable resource. In it readers get practical insights, tools, objectives, strategies and actions they can apply to any stage of their project--from initial ideas ...