Download How to Develop Robust Solid Oral Dosage Forms from Conception to Post-Approval Ebook PDF

How to Develop Robust Solid Oral Dosage Forms

How to Develop Robust Solid Oral Dosage Forms
From Conception to Post-Approval

by Bhavishya Mittal

  • Publisher : Academic Press
  • Release : 2016-10-05
  • Pages : 190
  • ISBN : 0128047321
  • Language : En, Es, Fr & De
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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

Principles of Parenteral Solution Validation

Principles of Parenteral Solution Validation
A Practical Lifecycle Approach

by Igor Gorsky,Harold S. Baseman

  • Publisher : Academic Press
  • Release : 2019-04-15
  • Pages : 208
  • ISBN : 0128094125
  • Language : En, Es, Fr & De
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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

An Industrial IoT Approach for Pharmaceutical Industry Growth

An Industrial IoT Approach for Pharmaceutical Industry Growth
Volume 2

by Valentina E. Balas,Vijender Kumar Solanki,Raghvendra Kumar

  • Publisher : Academic Press
  • Release : 2020-05-15
  • Pages : 382
  • ISBN : 0128213272
  • Language : En, Es, Fr & De
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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

How to Integrate Quality by Efficient Design (QbED) in Product Development

How to Integrate Quality by Efficient Design (QbED) in Product Development
A Book

by Bhavishya Mittal

  • Publisher : Academic Press
  • Release : 2019-08-24
  • Pages : 274
  • ISBN : 0128173041
  • Language : En, Es, Fr & De
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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

How to Optimize Fluid Bed Processing Technology

How to Optimize Fluid Bed Processing Technology
Part of the Expertise in Pharmaceutical Process Technology Series

by Dilip Parikh

  • Publisher : Academic Press
  • Release : 2017-04-04
  • Pages : 210
  • ISBN : 0128047283
  • Language : En, Es, Fr & De
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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

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition
A Book

by Anonim

  • Publisher : ScholarlyEditions
  • Release : 2012-01-09
  • Pages : 4229
  • ISBN : 1464963444
  • Language : En, Es, Fr & De
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Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Issues in Pediatric and Adolescent Medicine Research and Practice: 2011 Edition

Issues in Pediatric and Adolescent Medicine Research and Practice: 2011 Edition
A Book

by Anonim

  • Publisher : ScholarlyEditions
  • Release : 2012-01-09
  • Pages : 4090
  • ISBN : 1464963401
  • Language : En, Es, Fr & De
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Issues in Pediatric and Adolescent Medicine Research and Practice: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pediatric and Adolescent Medicine Research and Practice. The editors have built Issues in Pediatric and Adolescent Medicine Research and Practice: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pediatric and Adolescent Medicine Research and Practice in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pediatric and Adolescent Medicine Research and Practice: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.