A Guide To Particulate Science In Pharmaceutical Product Development
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A Guide To Particulate Science In Pharmaceutical Product Development
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Author : Margaret D. Louey
language : en
Publisher: CRC Press
Release Date : 2025-08-04
A Guide To Particulate Science In Pharmaceutical Product Development written by Margaret D. Louey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-08-04 with Medical categories.
The pharmaceutical applications of powder technology have long been recognized. Yet while many books focus on aspects of powder formation and behavior, there are few texts that explore the power of particulate science in the design, manufacture, and control of quality medicines. This revision discusses key principles and practical applications. The authors cover particulate material, its form and production, sampling from bodies of powder, particle size descriptors and statistics, behavior of particles and powder, instrumental analysis, particle size measurement and synergy of adopted techniques, and in vitro and in vivo performance criteria. Case studies are included in this new edition. This fully revised edition: Provides an essential account of particulate science including several new chapters on multicomponent particles, regulatory considerations and product development Presents a variety of topics ranging from the quality of published data on particle size in pharmaceuticals to the future of crystal engineering Reviews methods of particle measurement and their importance for specific applications Discusses misconceptions and misunderstandings of particulate science together with lessons from other industries
A Guide To Particulate Science In Pharmaceutical Product Development
DOWNLOAD
Author : Margaret D. Louey
language : en
Publisher:
Release Date : 2025-08-04
A Guide To Particulate Science In Pharmaceutical Product Development written by Margaret D. Louey and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-08-04 with Medical categories.
The pharmaceutical applications of powder technology have long been recognized. Yet while many books focus on aspects of powder formation and behaviour, there are few texts that explore the power of particulate science in the design, manufacture, and control of quality medicines.
Handbook Of Lung Targeted Drug Delivery Systems
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Author : Yashwant Pathak
language : en
Publisher: CRC Press
Release Date : 2021-10-17
Handbook Of Lung Targeted Drug Delivery Systems written by Yashwant Pathak and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-10-17 with Medical categories.
Handbook of Lung Targeted Drug Delivery Systems: Recent Trends and Clinical Evidences covers every aspect of the drug delivery to lungs, the physiology and pharmacology of the lung, modelling for lung delivery, drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications. With the advent of nano sciences and significant development in the nano particulate drug delivery systems there has been a renewed interest in the lung as an absorption surface for various drugs. The emergence of the COVID-19 virus has brought lung and lung delivery systems into focus, this book covers new developments and research used to address the prevention and treatment of respiratory diseases. Written by well-known scientists with years of experience in the field this timely handbook is an excellent reference book for the scientists and industry professionals. Key Features: Focuses particularly on the chemistry, clinical pharmacology, and biological developments in this field of research. Presents comprehensive information on emerging nanotechnology applications in diagnosing and treating pulmonary diseases Explores drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications Examines specific formulations targeted to pulmonary systems
Early Drug Development
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Author : Fabrizio Giordanetto
language : en
Publisher: John Wiley & Sons
Release Date : 2018-06-11
Early Drug Development written by Fabrizio Giordanetto and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-11 with Science categories.
This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
Pharmaceutical Powder And Particles
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Author : Anthony J. Hickey
language : en
Publisher: Springer Nature
Release Date : 2025-03-03
Pharmaceutical Powder And Particles written by Anthony J. Hickey and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-03-03 with Medical categories.
This book in the AAPS book series concisely reviews important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance. Hickey and Giovagnoli have written an essential book for any scientists involved in powder or particle research and manufacturing. It is appropriate for those just entering the field or as a rapid reference for the experienced pharmaceutical scientist. The authors have both academic and industrial experience, and the coverage includes solid state chemistry; crystallization; physical processes; particle size and distribution; particle interaction; manufacturing processes; quality by design; and a general discussion of the industry. Pharmaceutical Powder and Particles is intended to concisely review important aspects of powder and particle systems and the critical quality attributes that should be used as a guide to future developments intended to maximize the control of product quality and performance. Innovation in manufacturing has expanded the range of options available for solid dosage form manufacture while continuing to rely on first principles of solid-state chemistry and characterization methods for powders and particles. In this new edition, the authors have expanded on existing chapters and added sections on new developments in the recent and evolving manufacturing processes including additive manufacturing technologies, controlled crystallization, spray-freeze-drying technology, and more. The editors have also comprehensively updated the references throughout the entire book.
Pharmaco Complexity
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Author : Anthony J. Hickey
language : en
Publisher: Springer Nature
Release Date : 2020-06-24
Pharmaco Complexity written by Anthony J. Hickey and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-06-24 with Medical categories.
Non-linear phenomena pervade the pharmaceutical sciences. Understanding the interface between each of these phenomena and the way in which they contribute to overarching processes such as pharmaceutical product development may ultimately result in more efficient, less costly and rapid implementation. The benefit to Society is self-evident in that affordable treatments would be rapidly forthcoming. We have aggregated these phenomena into one topic “Pharmaco-complexity: Non-linear Phenomena and Drug Product Development”.
Design And Processing Of Particulate Products
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Author : Jim Litster
language : en
Publisher: Cambridge University Press
Release Date : 2016-10-20
Design And Processing Of Particulate Products written by Jim Litster and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-10-20 with Science categories.
A unique text providing comprehensive coverage of fundamental particle science, processing and technology. Including quantitative tools, real-world case studies and end-of-chapter problems, it is ideal for students in engineering and applied sciences, as well as for practitioners in a range of industries manufacturing particulate products.
Pharmaceutical Drug Product Development And Process Optimization
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Author : Sarwar Beg
language : en
Publisher: CRC Press
Release Date : 2020-05-01
Pharmaceutical Drug Product Development And Process Optimization written by Sarwar Beg and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-05-01 with Business & Economics categories.
Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.
Pharmaceutical Quality By Design
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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-03-19
Pharmaceutical Quality By Design written by Walkiria S. Schlindwein and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-19 with Science categories.
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Developing Solid Oral Dosage Forms
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Author : Yihong Qiu
language : en
Publisher: Academic Press
Release Date : 2009-03-10
Developing Solid Oral Dosage Forms written by Yihong Qiu and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-03-10 with Medical categories.
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