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How To Develop Robust Solid Oral Dosage Forms From Conception To Post Approval

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How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2016-10-05
ISBN : 0128047321
Language : En, Es, Fr & De

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Book Description :

How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval uses a practical and hands-on approach to cover the development process of solid oral dosage forms in one single source. The book details all of the necessary steps from formulation through the post-approval phase and contains industry case studies, real world advice, and troubleshooting tips. By merging the latest scientific information with practical instructions, this book provides pharmaceutical scientists in formulation research and development with a concrete look at the key aspects in the development of solid oral dosage forms. Focuses on important topics, such as robustness, bioavailability, formulation design, continuous processing, stability tests, modified release dosage forms, international guidelines, process scale-up, and much more Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Discusses common, real-world problems and offers both theoretical and practical solutions to these everyday issues

How to Integrate Quality by Efficient Design QbED in Product Development

How to Integrate Quality by Efficient Design  QbED  in Product Development Book
Author : Bhavishya Mittal
Publisher : Academic Press
Release : 2019-08-24
ISBN : 0128173041
Language : En, Es, Fr & De

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Book Description :

The development of a robust drug product requires juggling many competing priorities such as overcoming scientific challenges, following regulatory requirements, and managing business-related concerns. Unfortunately, despite large resources spent on R&D, multifactor productivity of pharmaceuticals is on the decline for several years now. Because of this business reality, pharmaceutical companies have seen a notable change in the traditional operating model and footprint over the past couple of decades. Outsourcing, in particular, has emerged as a successful business model for many pharmaceutical companies looking for ways to strategically increase their R&D capabilities and to augment their in-house resources. How to Integrate Quality by Efficient Design (QbED) in Product Development bridges the gap between theory and practice when it comes to strategic decision-making in a pharmaceutical research scenario. This book will introduce the concept of QbED and focus on various aspects such as patient-centric product designs, platform-based manufacturing technologies, business acuity, and regulatory strategies to balance the challenges in outsourcing with the need for strategic and statistically sound experiments rooted in good science. Detailed discussions will cover pharmaceutical business models, regulatory approval process, quality by design (QbD), business analytics, and manufacturing excellence specifically for small molecules and solid oral dosage forms. With the addition of case studies, flowcharts, diagrams, and data visualizations, How to Integrate Quality by Efficient Design (QbED) in Product Development will be a practical reference to help professionals working in the area of pharmaceutical drug development, strategy, and outsourcing management. Part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin Integrates pharmaceutical business models, economics, and outsourcing-related challenges into pharmaceutical product development Discusses relevant literature references in quality risk management, business strategy, QbD, and product development Provides decision-making flowcharts, conceptual diagrams, and data visualizations to make the book useful, easy to read, and to understand

An Industrial IoT Approach for Pharmaceutical Industry Growth

An Industrial IoT Approach for Pharmaceutical Industry Growth Book
Author : Valentina Emilia Balas,Vijender Kumar Solanki,Raghvendra Kumar
Publisher : Academic Press
Release : 2020-05-15
ISBN : 0128213272
Language : En, Es, Fr & De

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Book Description :

An Industrial IoT Approach for Pharmaceutical Industry Growth, Volume Two uses an innovative approach to explore how the Internet of Things (IoT) and big data can improve approaches and make discoveries. Rapid growth of the IoT has encouraged many companies in the manufacturing sector to make use of this technology to unlock its potential. Using clear language and real-world case studies, this book discusses systems level from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing. The wide variety in topics presented offers multiple perspectives on how to integrate the Internet of Things into pharmaceutical manufacturing. This book represents a useful resource for researchers in pharmaceutical sciences, information and communication technologies, and those who specialize in healthcare and pharmacovigilance. Emphasizes efficiency in pharmaceutical manufacturing through an IoT/Big Data approach Explores cutting-edge technologies through sensor enabled environments in the pharmaceutical industry Discusses system levels from both a human-factors point-of-view and the perspective of networking, databases, privacy and anti-spoofing

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation Book
Author : Igor Gorsky,Harold S. Baseman
Publisher : Academic Press
Release : 2019-11-27
ISBN : 012809446X
Language : En, Es, Fr & De

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Book Description :

Principles of Parenteral Solution Validation: A Practical Lifecycle Approach covers all aspects involved in the development and process validation of a parenteral product. By using a lifecycle approach, this book discusses the latest technology, compliance developments, and regulatory considerations and trends, from process design, to divesting. As part of the Expertise in Pharmaceutical Process Technology series edited by Michael Levin, this book incorporates numerous case studies and real-world examples that address timely problems and offer solutions to the daily challenges facing practitioners in this area. Discusses international and domestic regulatory considerations in every section Features callout boxes that contain points-of-interest for each segment of the audience so readers can quickly find their interests and needs Contains important topics, including risk management, the preparation and execution of properly designed studies, scale-up and technology transfer activities, problem-solving, and more

Removal of Pollutants from Saline Water

Removal of Pollutants from Saline Water Book
Author : Shaik Feroz,Detlef W. Bahnemann
Publisher : CRC Press
Release : 2021-12-23
ISBN : 1000520625
Language : En, Es, Fr & De

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Book Description :

Removal of Pollutants from Saline Water: Treatment Technologies provides a comprehensive understanding of technologies that are currently adopted in the treatment of pollutants present in saline water systems. It provides information on the treatment technologies for saline water systems, including seawater, brackish water, oil-produced water, and other industrial saline wastewaters. FEATURES Presents information exclusively for saline water pollutant removal Introduces current treatment technologies and addresses why and how the techniques differ between fresh and salt water Offers an inclusive overview of physicochemical, biological, membrane, and advanced oxidation treatment technologies Features various perspectives and case studies from relevant global experts Provides a comprehensive one-stop source for the treatment of pollutants in all saline water systems Aimed at students, academicians, researchers, and practicing engineers in the fields of chemical, civil, marine, and environmental engineering who wish to be acquainted with the most recent developments in the treatment of pollutants present in saline water systems. Prof. Dr. Shaik Feroz works at Prince Mohammad Bin Fahd University, Kingdom of Saudi Arabia. He has 30 years of experience in teaching, research, and industry. He has more than 190 publications to his credit in journals and conferences of international repute. He was awarded "Best Researcher" by Caledonian College of Engineering for the year 2014. Prof. Dr. Detlef W. Bahnemann is Head of the Research Unit, Photocatalysis and Nanotechnology at Leibniz University Hannover (Germany), Director of the Research Institute "Nanocomposite Materials for Photonic Applications" at Saint Petersburg State University (Russian Federation), and Distinguished Professor at Shaanxi University of Science and Technology in Xi’an (People's Republic of China). His research topics include photocatalysis, photoelectrochemistry, solar chemistry, and photochemistry focused on synthesis and physical-chemical properties of semiconductor and metal nanoparticles. His 500-plus publications have been cited more than 65,000 times (h-index: 100).

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology Book
Author : Dilip Parikh
Publisher : Academic Press
Release : 2017-04-04
ISBN : 0128047283
Language : En, Es, Fr & De

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Book Description :

How to Optimize Fluid Bed Processing Technology: Part of the Expertise in Pharmaceutical Process Technology Series addresses the important components of fluid bed granulation, providing answers to problems that commonly arise and using numerous practical examples and case studies as reference. This book covers the theoretical concepts involved in fluidization, also providing a description of the choice and functionality of equipment. Additional chapters feature key aspects of the technology, including formulation requirements, process variables, process scale-up, troubleshooting, new development, safety, and process evaluation. Given its discussion of theoretical principles and practical solutions, this is a go-to resource for all those scientists and new researchers working with fluid bed granulation as a unit operation. Written by an expert in the field with several years of experience in product development, manufacturing, plant operations, and process engineering Illustrates when fluid bed granulation is needed, when to use less common fluid bed granulation methods, and the advantages of fluid bed granulation when compared to other granulation techniques Offers troubleshooting tips and practical advice for scientists working with this technique

Developing Solid Oral Dosage Forms

Developing Solid Oral Dosage Forms Book
Author : Yihong Qiu,Yisheng Chen,Geoff G.Z. Zhang,Lirong Liu,William Porter
Publisher : Academic Press
Release : 2009-03-10
ISBN : 9780080932729
Language : En, Es, Fr & De

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Book Description :

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 Dosage Forms

Pharmaceutical Dosage Forms Book
Author : Larry L. Augsburger,Stephen W. Hoag
Publisher : CRC Press
Release : 2017-10-30
ISBN : 1351620398
Language : En, Es, Fr & De

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Book Description :

Pharmaceutical Dosage Forms: Capsules covers the development, composition, and manufacture of capsules. Despite the important role that capsules play in drug delivery and product development, few comprehensive texts on the science and technology of capsules have been available for the research and academic environments. This text addresses this gap, discussing how capsules provide unique capabilities and options for dosage form design and formulation.