Pharmaceutical Process Scale Up Third Edition

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Pharmaceutical Process Scale-Up, Third Edition

Author : Michael Levin
Publisher : CRC Press
ISBN 13 : 9781616310011
Total Pages : 0 pages
Book Rating : 4.3/5 (1 download)

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Book Synopsis Pharmaceutical Process Scale-Up, Third Edition by : Michael Levin

Download or read book Pharmaceutical Process Scale-Up, Third Edition written by Michael Levin and published by CRC Press. This book was released on 2011-02-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The third edition of Pharmaceutical Process Scale-Up deals with the theory and practice of scale-up in the pharmaceutical industry. This thoroughly revised edition reflects the rapid changes in the field and includes: New material on tableting scale-up and compaction. Regulatory appendices that cover FDA and EU Guidelines. New chapters on risk evaluation and validation as related to scale-up. Practical advice on scale-up solutions from world renowned experts in the field. Pharmaceutical Process Scale-Up, Third Edition will provide an excellent insight in to the practical aspects of the process scale-up and will be an invaluable source of information on batch enlargement techniques for formulators, process engineers, validation specialists and quality assurance personnel, as well as production managers. It will also provide interesting reading material for anyone involved in Process Analytical Technology (PAT), technology transfer and product globalization.

Pharmaceutical Process Scale-Up

Author : Michael Levin
Publisher : CRC Press
ISBN 13 : 082474196X
Total Pages : 588 pages
Book Rating : 4.8/5 (247 download)

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Book Synopsis Pharmaceutical Process Scale-Up by : Michael Levin

Download or read book Pharmaceutical Process Scale-Up written by Michael Levin and published by CRC Press. This book was released on 2001-12-12 with total page 588 pages. Available in PDF, EPUB and Kindle. Book excerpt: Focusing on scientific and practical aspects of process scale-up, this resource details the theory and practice of transferring pharmaceutical processes from laboratory scale to the pilot plant and production scale. It covers parenteral and nonparenterel liquids and semi-solids, products derived from biotechnology, dry blending and powder handling,

Pharmaceutical Process Scale-Up, Second Edition

Author : Michael Levin
Publisher : CRC Press
ISBN 13 : 9781574448764
Total Pages : 576 pages
Book Rating : 4.4/5 (487 download)

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Book Synopsis Pharmaceutical Process Scale-Up, Second Edition by : Michael Levin

Download or read book Pharmaceutical Process Scale-Up, Second Edition written by Michael Levin and published by CRC Press. This book was released on 2005-10-18 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: Keeping pace with the increased influence of PAT in the pharmaceutical industry, this completely updated reference spans the latest research and regulations, technologies, and expert solutions for every significant aspect of pharmaceutical process scale-up-clearly introducing readers to the theoretical concept of dimensional analysis to quantify similar processes on varying scales.

Pharmaceutical Process Engineering and Scale-up Principles

Author : Anil B. Jindal
Publisher : Springer Nature
ISBN 13 : 3031313801
Total Pages : 226 pages
Book Rating : 4.0/5 (313 download)

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Book Synopsis Pharmaceutical Process Engineering and Scale-up Principles by : Anil B. Jindal

Download or read book Pharmaceutical Process Engineering and Scale-up Principles written by Anil B. Jindal and published by Springer Nature. This book was released on 2023-07-03 with total page 226 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book offers a comprehensive overview of the unit operations involved in the manufacturing process of solid and liquid dosage forms, along with the scale-up of each operation. This book is a valuable resource for professionals working in the pharmaceutical industry and researchers seeking to develop a comprehensive understanding of the various aspects of the manufacturing process. The book is divided into four sections, covering a range of topics. Section I provide readers with a comprehensive understanding of the basic principles behind the manufacturing process of solid and liquid dosage forms. Section II covers the different unit operations involved in the production of solid dosage forms, including mixing, granulation, drying, compression, coating, and size reduction. This section includes case studies to provide readers with practical insights into the scale-up principles involved in the manufacturing process. Section III focuses on the manufacturing and scale-up of liquid formulations, covering topics such as mixing, filtration, and scale-up of liquid mixing process. This section offers a comprehensive understanding of the various aspects of the manufacturing process, including the challenges and opportunities associated with the scale-up of liquid formulations. Finally, Section IV includes two chapters that describe the manufacturing and scale-up of advanced drug delivery systems, including the manufacturing and scale-up of nanoparticles and biotechnology-derived products. This section provides readers with insights into the development of innovative drug delivery systems and the challenges involved in their scale-up. Overall, the book is an essential guide for professionals and researchers seeking a deeper understanding of the manufacturing process. The case studies and practical examples offer valuable insights into the challenges and opportunities involved in the scale-up process, making it an indispensable resource for those involved in the pharmaceutical industry. Only book that is dedicated to pharmaceutical process engineering and scale-up; Contain numerous case studies for easy reference; Covers solid, liquid, and advanced dosage forms.

Pharmaceutical Process Chemistry for Synthesis

Author : Peter J. Harrington
Publisher : John Wiley & Sons
ISBN 13 : 0470922869
Total Pages : 815 pages
Book Rating : 4.4/5 (79 download)

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Book Synopsis Pharmaceutical Process Chemistry for Synthesis by : Peter J. Harrington

Download or read book Pharmaceutical Process Chemistry for Synthesis written by Peter J. Harrington and published by John Wiley & Sons. This book was released on 2011-02-23 with total page 815 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is a need to explain that generic versions of a drug may not be manufactured by the same process as brand-name drugs and that the different processes may have dramatically different environmental impacts. Two global forces are at odds today—the push for "greener" processes and the push for lower drug prices. This book brings this conflict into sharp focus by discussing in detail the published process chemistry for top-selling small molecule drugs. Providing insights about process route selection, choice of reagents, and reaction conditions, Pharmaceutical Process Chemistry for Synthesis guides process chemists in identifying best processes for manufacturing these blockbuster drugs as they lose patent protection. Further, it highlights the strategies and methodology that might be useful for expediting the process research and development of the blockbusters of the future. Written from a refreshingly objective perspective, this book is essential for process chemists who need to devise practical syntheses for increasingly complex drugs in a constantly decreasing time frame.

Pharmaceutical Process Development

Author : John Blacker
Publisher : Royal Society of Chemistry
ISBN 13 : 1849733074
Total Pages : 375 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Process Development by : John Blacker

Download or read book Pharmaceutical Process Development written by John Blacker and published by Royal Society of Chemistry. This book was released on 2011-08-17 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.

Advanced Aseptic Processing Technology

Author : James Agalloco
Publisher : CRC Press
ISBN 13 : 1439825440
Total Pages : 495 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Advanced Aseptic Processing Technology by : James Agalloco

Download or read book Advanced Aseptic Processing Technology written by James Agalloco and published by CRC Press. This book was released on 2016-04-19 with total page 495 pages. Available in PDF, EPUB and Kindle. Book excerpt: The preparation of sterile products using aseptic processing is considered perhaps the most critical process in the pharmaceutical industry and has witnessed continual improvement over the last half century. New approaches that have transformed classical aseptic production methods are appearing almost daily. This book reviews emerging technologies

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Author : Anthony J. Hickey
Publisher : CRC Press
ISBN 13 : 0429619561
Total Pages : 784 pages
Book Rating : 4.4/5 (296 download)

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Book Synopsis Pharmaceutical Inhalation Aerosol Technology, Third Edition by : Anthony J. Hickey

Download or read book Pharmaceutical Inhalation Aerosol Technology, Third Edition written by Anthony J. Hickey and published by CRC Press. This book was released on 2019-03-26 with total page 784 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

Process Validation in Manufacturing of Biopharmaceuticals, Third Edition

Author : Anurag S. Rathore
Publisher : CRC Press
ISBN 13 : 1439850933
Total Pages : 535 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Process Validation in Manufacturing of Biopharmaceuticals, Third Edition by : Anurag S. Rathore

Download or read book Process Validation in Manufacturing of Biopharmaceuticals, Third Edition written by Anurag S. Rathore and published by CRC Press. This book was released on 2012-05-09 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qualify scale-down models A matrix approach for process validation of a multivalent bacterial vaccine Purification validation for a therapeutic monoclonal antibody expressed and secreted by Chinese Hamster Ovary (CHO) cells Viral clearance validation studies for a product produced in a human cell line A much-needed resource, this book presents process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration. It also provides practical methods to test raw materials and in-process samples. Stressing the importance of taking a risk-based approach towards computerized system compliance, this book will help you and your team ascertain process validation is carried out and exceeds expectations.

Pharmaceutical Process Development

Author : A. John Blacker
Publisher : Royal Society of Chemistry
ISBN 13 : 1849731462
Total Pages : 375 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Pharmaceutical Process Development by : A. John Blacker

Download or read book Pharmaceutical Process Development written by A. John Blacker and published by Royal Society of Chemistry. This book was released on 2011 with total page 375 pages. Available in PDF, EPUB and Kindle. Book excerpt: 'Pharmaceutical Process Development' is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry and informs them about the breadth of the work carried out in chemical research and development departments.

Handbook of Pharmaceutical Granulation Technology

Author : Dilip M. Parikh
Publisher : CRC Press
ISBN 13 : 1000366383
Total Pages : 905 pages
Book Rating : 4.0/5 (3 download)

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Book Synopsis Handbook of Pharmaceutical Granulation Technology by : Dilip M. Parikh

Download or read book Handbook of Pharmaceutical Granulation Technology written by Dilip M. Parikh and published by CRC Press. This book was released on 2021-05-11 with total page 905 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theoretical discussions covering granulation and engineering perspectives. Covers new advances in expert systems, process modelling and bioavailability Chapters on emerging technologies in particle engineering Updated Current research and developments in granulation technologies

Manufacturing of Pharmaceutical Proteins

Author : Stefan Behme
Publisher : John Wiley & Sons
ISBN 13 : 3527349472
Total Pages : 422 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Manufacturing of Pharmaceutical Proteins by : Stefan Behme

Download or read book Manufacturing of Pharmaceutical Proteins written by Stefan Behme and published by John Wiley & Sons. This book was released on 2022-04-18 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: An expert, single-volume overview of the core processes and disciplines of biopharmaceutical production In the newly revised Third Edition of Manufacturing of Pharmaceutical Proteins: From Technology to Economy, renowned chemical engineer Dr. Stefan Behme delivers a comprehensive text covering all aspects of biopharmaceutical manufacturing, including legal and regulatory considerations, production facility design, quality assurance, supply chain management, emerging market regulations, and cost control. Suitable as both a reference book and a training resource, this book extensively explores the impact of digital transformation on pharmaceutical protein manufacturers and includes a brand-new chapter dedicated to digitalization. The distinguished author provides readers with practical understanding of the terminology and principles driving the various fields involved with biotechnological production, including operations, legal, finance, and IT. He also offers: A thorough introduction to biopharmaceutical production, including value creation, product types, and biological basics Comprehensive explorations of the technology of the manufacturing process and analytics Practical discussions of pharmacology and drug safety, quality assurance, and pharmaceutical law In-depth examinations of pharmaceutical protein production facilities, including facility design and the planning, construction, and commissioning of a manufacturing plant Perfect for biotechnologists working in the pharmaceutical industry, Manufacturing of Pharmaceutical Proteins: From Technology to Economy will also earn a place in the libraries of pharmaceutical engineers seeking a one-stop reference for all aspects of biopharmaceutical production.

Developing Solid Oral Dosage Forms

Author : Yihong Qiu
Publisher : Academic Press
ISBN 13 : 008093272X
Total Pages : 976 pages
Book Rating : 4.0/5 (89 download)

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Book Synopsis Developing Solid Oral Dosage Forms by : Yihong Qiu

Download or read book Developing Solid Oral Dosage Forms written by Yihong Qiu and published by Academic Press. This book was released on 2009-03-10 with total page 976 pages. Available in PDF, EPUB and Kindle. Book excerpt: Developing Solid Oral Dosage Forms is intended for pharmaceutical professionals engaged in research and development of oral dosage forms. It covers essential principles of physical pharmacy, biopharmaceutics and industrial pharmacy as well as various aspects of state-of-the-art techniques and approaches in pharmaceutical sciences and technologies along with examples and/or case studies in product development. The objective of this book is to offer updated (or current) knowledge and skills required for rational oral product design and development. The specific goals are to provide readers with: Basics of modern theories of physical pharmacy, biopharmaceutics and industrial pharmacy and their applications throughout the entire process of research and development of oral dosage forms Tools and approaches of preformulation investigation, formulation/process design, characterization and scale-up in pharmaceutical sciences and technologies New developments, challenges, trends, opportunities, intellectual property issues and regulations in solid product development The first book (ever) that provides comprehensive and in-depth coverage of what's required for developing high quality pharmaceutical products to meet international standards It covers a broad scope of topics that encompass the entire spectrum of solid dosage form development for the global market, including the most updated science and technologies, practice, applications, regulation, intellectual property protection and new development trends with case studies in every chapter A strong team of more than 50 well-established authors/co-authors of diverse background, knowledge, skills and experience from industry, academia and regulatory agencies

Pharmaceutical Process Engineering

Author : Anthony J. Hickey
Publisher : CRC Press
ISBN 13 : 1420084763
Total Pages : 230 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Process Engineering by : Anthony J. Hickey

Download or read book Pharmaceutical Process Engineering written by Anthony J. Hickey and published by CRC Press. This book was released on 2016-03-09 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: With step-by-step methods of drug production and knowledge of major unit operations and key concepts of pharmaceutical engineering, this guide will help to improve communication among the varied professionals working in the pharmaceutical industry. Key features: REVISION OF A BESTSELLER - Updates include recent advances in the field to keep pharmac

Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology

Author : Alexandru Mihai Grumezescu
Publisher : William Andrew
ISBN 13 : 0128136308
Total Pages : 704 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology by : Alexandru Mihai Grumezescu

Download or read book Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology written by Alexandru Mihai Grumezescu and published by William Andrew. This book was released on 2017-12-11 with total page 704 pages. Available in PDF, EPUB and Kindle. Book excerpt: Nanoscale Fabrication, Optimization, Scale-up and Biological Aspects of Pharmaceutical Nanotechnology focuses on the fabrication, optimization, scale-up and biological aspects of pharmaceutical nanotechnology. In particular, the following aspects of nanoparticle preparation methods are discussed: the need for less toxic reagents, simplification of the procedure to allow economic scale-up, and optimization to improve yield and entrapment efficiency. Written by a diverse range of international researchers, the chapters examine characterization and manufacturing of nanomaterials for pharmaceutical applications. Regulatory and policy aspects are also discussed. This book is a valuable reference resource for researchers in both academia and the pharmaceutical industry who want to learn more about how nanomaterials can best be utilized. Shows how nanomanufacturing techniques can help to create more effective, cheaper pharmaceutical products Explores how nanofabrication techniques developed in the lab have been translated to commercial applications in recent years Explains safety and regulatory aspects of the use of nanomanufacturing processes in the pharmaceutical industry

Industrial Process Scale-up

Author : Jan Harmsen
Publisher : Elsevier
ISBN 13 : 0444642846
Total Pages : 142 pages
Book Rating : 4.4/5 (446 download)

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Book Synopsis Industrial Process Scale-up by : Jan Harmsen

Download or read book Industrial Process Scale-up written by Jan Harmsen and published by Elsevier. This book was released on 2019-05-16 with total page 142 pages. Available in PDF, EPUB and Kindle. Book excerpt: Industrial Process Scale-up: A Practical Innovation Guide from Idea to Commercial Implementation, Second Edition helps industrial process innovators in research, development and commercial start-ups assess the risks of commercial-scale implementation, also providing them with practical guidelines and methods to reduce the risks to acceptable levels. In addition, the book can be used in cooperation with industrial R&D people and academic researchers to shape open innovation programs, and in education as a reference book. This updated edition has the latest literature and has been expanded with a scale-up of pharmaceutical processes and their history in both academia and the process industries. Offers easily accessible, step-by-step and concise guidelines for industrial process scale-up Explains each stage of the innovation funnel, from research, development, demonstration and commercial implementation for any process type and branch Based on industrial experiences and practices that reduce the risks of commercial scale implementation of new processes to acceptable levels and reduce cost and time of process innovation

Drug Delivery Systems, Third Edition

Author : Vasant V. Ranade
Publisher : CRC Press
ISBN 13 : 1439806187
Total Pages : 610 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Drug Delivery Systems, Third Edition by : Vasant V. Ranade

Download or read book Drug Delivery Systems, Third Edition written by Vasant V. Ranade and published by CRC Press. This book was released on 2011-04-25 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug delivery technologies represent a vast, vital area of research and development in pharmaceuticals. The demand for innovative drug delivery systems continues to grow, driving a variety of new developments. Drug Delivery Systems, Third Edition provides a comprehensive review of the latest research and development on drug delivery systems. Coverage includes liposomal, transmucosal, transdermal, oral, polymeric, and monoclonal antibody directed delivery. Each chapter provides a table of marketed and investigational products with numerous practical examples. The book also provides readers with a multitude of possible drug delivery systems that can be used to improve therapeutics, along with global and regulatory perspectives. This third edition contains a chapter on nanoscience and technology for drug delivery along with cutting-edge business intelligence and strategies. Written in a straightforward manner, the authors provide a global perspective on current and future advances and market opportunities. Supplying a cogent overview of the field and extensive guidance on where to get more information, it is an essential resource for anyone venturing into this area of drug development.