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| Author | : Michael Levin |
| Publisher | : CRC Press |
| Total Pages | : 0 |
| Release | : 2011-02-02 |
| Genre | : Medical |
| ISBN | : 9781616310011 |
Download Pharmaceutical Process Scale-Up, Third Edition Book in PDF, ePub and Kindle
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.
| Author | : Michael Levin |
| Publisher | : CRC Press |
| Total Pages | : 588 |
| Release | : 2001-12-12 |
| Genre | : Medical |
| ISBN | : 082474196X |
Download Pharmaceutical Process Scale-Up Book in PDF, ePub and Kindle
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,
| Author | : Michael Levin |
| Publisher | : CRC Press |
| Total Pages | : 576 |
| Release | : 2005-10-18 |
| Genre | : Medical |
| ISBN | : 9781574448764 |
Download Pharmaceutical Process Scale-Up, Second Edition Book in PDF, ePub and Kindle
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.
| Author | : Anil B. Jindal |
| Publisher | : Springer Nature |
| Total Pages | : 226 |
| Release | : 2023-07-03 |
| Genre | : Medical |
| ISBN | : 3031313801 |
Download Pharmaceutical Process Engineering and Scale-up Principles Book in PDF, ePub and Kindle
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.
| Author | : Peter J. Harrington |
| Publisher | : John Wiley & Sons |
| Total Pages | : 815 |
| Release | : 2011-02-23 |
| Genre | : Science |
| ISBN | : 0470922869 |
Download Pharmaceutical Process Chemistry for Synthesis Book in PDF, ePub and Kindle
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.
| Author | : Anthony J. Hickey |
| Publisher | : CRC Press |
| Total Pages | : 784 |
| Release | : 2019-03-26 |
| Genre | : Medical |
| ISBN | : 0429619561 |
Download Pharmaceutical Inhalation Aerosol Technology, Third Edition Book in PDF, ePub and Kindle
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
| Author | : Anurag S. Rathore |
| Publisher | : CRC Press |
| Total Pages | : 535 |
| Release | : 2012-05-09 |
| Genre | : Medical |
| ISBN | : 1439850933 |
Download Process Validation in Manufacturing of Biopharmaceuticals, Third Edition Book in PDF, ePub and Kindle
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.
| Author | : Anthony J. Hickey |
| Publisher | : CRC Press |
| Total Pages | : 230 |
| Release | : 2016-03-09 |
| Genre | : Medical |
| ISBN | : 1420084763 |
Download Pharmaceutical Process Engineering Book in PDF, ePub and Kindle
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
| Author | : A. John Blacker |
| Publisher | : Royal Society of Chemistry |
| Total Pages | : 375 |
| Release | : 2011 |
| Genre | : Medical |
| ISBN | : 1849731462 |
Download Pharmaceutical Process Development Book in PDF, ePub and Kindle
'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.
| Author | : Dilip M. Parikh |
| Publisher | : CRC Press |
| Total Pages | : 905 |
| Release | : 2021-05-11 |
| Genre | : Medical |
| ISBN | : 1000366383 |
Download Handbook of Pharmaceutical Granulation Technology Book in PDF, ePub and Kindle
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
