9780470942376 - comprehensive quality by design for pharmaceutical product development and manufacture (12 risultati)
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Reklaitis, Gintaras V. (EDT); Seymour, Christine (EDT); García-munoz, Salvador (EDT)
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Da: GreatBookPrices, Columbia, MD, U.S.A.GreatBookPrices
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EUR 145,04
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Condizione: New.
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Da: INDOO, Avenel, NJ, U.S.A.INDOO
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EUR 147,86
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Condizione: New. Brand New.
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Reklaitis, Gintaras V. (EDT); Seymour, Christine (EDT); García-munoz, Salvador (EDT)
- Rilegato
Da: GreatBookPrices, Columbia, MD, U.S.A.GreatBookPrices
Contatta il venditoreVenditore con 5 stelleCondizione: Usato - Come nuovo
EUR 167,85
EUR 2,31 spedizioneSpedito in U.S.A.Quantità: Più di 20 disponibili
Condizione: As New. Unread book in perfect condition.
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- Prima edizione
Da: Grand Eagle Retail, Bensenville, IL, U.S.A.Grand Eagle Retail
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EUR 183,63
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Hardcover. Condizione: new. Hardcover. 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 pr…oducts. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectorsdrug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processingReviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processesThe role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process. 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. Shipping may be from multiple locations in the US or from the UK, depending on stock availability.
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Reklaitis, Gintaras V. (EDT); Seymour, Christine (EDT); García-munoz, Salvador (EDT)
- Rilegato
Da: GreatBookPricesUK, Woodford Green, Regno UnitoGreatBookPricesUK
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EUR 175,20
EUR 17,56 spedizioneSpedito da Regno Unito a U.S.A.Quantità: Più di 20 disponibili
Condizione: As New. Unread book in perfect condition.
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- Prima edizione
Da: Kennys Bookshop and Art Galleries Ltd., Galway, GY, IrlandaKennys Bookshop and Art Galleries Ltd.
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EUR 195,20
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Condizione: New. 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. Num Pages: 592 pa…ges. BIC Classification: TDCW. Category: (P) Professional & Vocational. Dimension: 250 x 150. . . 2017. 1st Edition. Hardcover. . . . .
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Da: Ubiquity Trade, Miami, FL, U.S.A.Ubiquity Trade
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EUR 213,44
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Condizione: New. Brand new! Please provide a physical shipping address.
Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture
Reklaitis, Gintaras V. (EDT); Seymour, Christine (EDT); García-munoz, Salvador (EDT)
- Rilegato
Da: GreatBookPricesUK, Woodford Green, Regno UnitoGreatBookPricesUK
Contatta il venditoreVenditore con 5 stelleCondizione: Nuovo
EUR 198,32
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Condizione: New.
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- Prima edizione
Da: CitiRetail, Stevenage, Regno UnitoCitiRetail
Contatta il venditoreVenditore con 5 stelleCondizione: Nuovo
EUR 198,33
EUR 43,31 spedizioneSpedito da Regno Unito a U.S.A.Quantità: 1 disponibili
Hardcover. Condizione: new. Hardcover. 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 pr…oducts. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectorsdrug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processingReviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processesThe role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process. 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. Shipping may be from our UK warehouse or from our Australian or US warehouses, depending on stock availability.
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Da: moluna, Greven, Germaniamoluna
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EUR 194,99
EUR 48,99 spedizioneSpedito da Germania a U.S.A.Quantità: Più di 20 disponibili
Condizione: New. GINTARAS.V. REKLAITIS, PhD, is Professor of Chemical Engineering and Industrial & Physical Pharmacy at Purdue University, member of the U.S. National Academy of Engineering, and the Deputy Director of the NSF Engineering Research Center on Structured Organi.
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Da: Kennys Bookstore, Olney, MD, U.S.A.Kennys Bookstore
Contatta il venditoreVenditore con 5 stelleCondizione: Nuovo
EUR 249,29
EUR 9,18 spedizioneSpedito in U.S.A.Quantità: 15 disponibili
Condizione: New. 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. Num Pages: 592 pa…ges. BIC Classification: TDCW. Category: (P) Professional & Vocational. Dimension: 250 x 150. . . 2017. 1st Edition. Hardcover. . . . . Books ship from the US and Ireland.
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- Prima edizione
Da: AussieBookSeller, Truganina, VIC, AustraliaAussieBookSeller
Contatta il venditoreVenditore con 5 stelleCondizione: Nuovo
EUR 283,28
EUR 32,34 spedizioneSpedito da Australia a U.S.A.Quantità: 1 disponibili
Hardcover. Condizione: new. Hardcover. 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 pr…oducts. QbD is seen as a framework for building process understanding, for implementing robust and effective manufacturing processes and provides the underpinnings for a science-based regulation of the pharmaceutical industry. Edited by the three renowned researchers in the field, Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture guides pharmaceutical engineers and scientists involved in product and process development, as well as teachers, on how to utilize QbD practices and applications effectively while complying with government regulations. The material is divided into three main sections: the first six chapters address the role of key technologies, including process modeling, process analytical technology, automated process control and statistical methodology in supporting QbD and establishing the associated design space. The second section consisting of seven chapters present a range of thoroughly developed case studies in which the tools and methodologies discussed in the first section are used to support specific drug substance and drug-product QbD related developments. The last section discussed the needs for integrated tools and reviews the status of information technology tools available for systematic data and knowledge management to support QbD and related activities. Highlights Demonstrates Quality by Design (QbD) concepts through concrete detailed industrial case studies involving of the use of best practices and assessment of regulatory implications Chapters are devoted to applications of QbD methodology in three main processing sectorsdrug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processingReviews the spectrum of process model types and their relevance, the range of state-of-the-art real-time monitoring tools and chemometrics, and alternative automatic process control strategies and methods for both batch and continuous processesThe role of the design space is demonstrated through specific examples and the importance of understanding the risk management aspects of design space definition is highlighted Comprehensive Quality by Design for Pharmaceutical Product Development and Manufacture is an ideal book for practitioners, researchers, and graduate students involved in the development, research, or studying of a new drug and its associated manufacturing process. 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. Shipping may be from our Sydney, NSW warehouse or from our UK or US warehouse, depending on stock availability.
