Gintaras V. Reklaitis – författare

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 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 sectors—drug 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 highlightedComprehensive 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.

A thorough introduction to balance equation concepts. Geared for the course offered to chemical engineering majors in their sophomore year. Develops a framework for the analysis of flowsheet problem information with extensive use of degree-of-freedom analysis. Presents systematic approaches for manual and computer-aided solution of full scale balance problems. Provides a detailed development of the structure, properties, and interrelationships of species and element balances based on the algebraic view of reaction-stoichiometry and the rate of reaction concept.

The classic introduction to engineering optimization theory and practice--now expanded and updated Engineering optimization helps engineers zero in on the most effective, efficient solutions to problems. This text provides a practical, real-world understanding of engineering optimization. Rather than belaboring underlying proofs and mathematical derivations, it emphasizes optimization methodology, focusing on techniques and stratagems relevant to engineering applications in design, operations, and analysis. It surveys diverse optimization methods, ranging from those applicable to the minimization of a single-variable function to those most suitable for large-scale, nonlinear constrained problems. New material covered includes the duality theory, interior point methods for solving LP problems, the generalized Lagrange multiplier method and generalization of convex functions, and goal programming for solving multi-objective optimization problems. A practical, hands-on reference and text, Engineering Optimization, Second Edition covers:* Practical issues, such as model formulation, implementation, starting point generation, and more* Current, state-of-the-art optimization software* Three engineering case studies plus numerous examples from chemical, industrial, and mechanical engineering* Both classical methods and new techniques, such as successive quadratic programming, interior point methods, and goal programming Excellent for self-study and as a reference for engineering professionals, this Second Edition is also ideal for senior and graduate courses on engineering optimization, including television and online instruction, as well as for in-plant training.

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 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 sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews 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 processes The 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.

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 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 sectors—drug substance process development, oral drug product manufacture, parenteral product processing, and solid-liquid processing Reviews 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 processes The 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.

Batch chemical processing has in the past decade enjoyed a return to respectability as a valuable, effective, and often preferred mode of process operation. This book provides the first comprehensive and authoritative coverage that reviews the state of the art development in the field of batch chemical systems engineering, applications in various chemical industries, current practice in different parts of the world, and future technical challenges. Developments in enabling computing technologies such as simulation, mathematical programming, knowledge based systems, and prognosis of how these developments would impact future progress in the batch domain are covered. Design issues for complex unit processes and batch plants as well as operational issues such as control and scheduling are also addressed.