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3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Professor Abdul Basit is a Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul's research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. His research has been translated into the design of new technologies and improved disease treatments, many of which have been commercialised. Abdul is also a serial entrepreneur and has filed multiple patents, is the recepient of several research awards and has founded 3 companies (Kuecept, Intract Pharma, FabRx). He further serves as a consultant to many pharmaceutical organisations and is on the advisory boards of scientific journals, healthcare and charitable bodies. Professor Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters, 4 authored books and is the recipient of multiple research awards. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, translating his expertise by co-founding FabRx. Simon is also an expert in the physicochemical characterisation of compounds and formulations with thermal methods and calorimetry.

"Pharmaceutical Public Policy provides the understanding and framework required for effective organization, financing, and delivery of pharmaceutical products and services. It supplies an overview of the policy process as well as the roles of legislation and regulation in pharmaceutical policy. The book identifies the goals, objectives, and key policy issues of concern to stakeholders involved in the development of products, use of pharmaceuticals in healthcare, and administration of insurance programs by both the private and government sectors. Policy issues examined include the appropriateness of prescribing and patient adherence. Addressing questions of access, quality, and cost, the book considers the operation of the Affordable Care Act and Medicare Part D. It details the responsibilities of Federal providers of pharmaceutical care and private and public payers such as managed care organizations, pharmacy benefit managers, Medicare, and Medicaid. The book covers the policies and practices involved in promoting pharmaceutical products. It also considers pharmacoeconomics as a response to market failure. Finally, the book describes the market, the role of the manufacturer, drug shortages, and the responsibilities of the FDA."--

Intro -- Preface -- Contents -- Contributors -- About the Editors -- Chapter 1: The Shape of Things to Come: Emerging Applications of 3D Printing in Healthcare -- 1 3D Printing: The Next Industrial Revolution -- 1.1 3D Printing in Medicine: An Overview -- 2 Personalised Medicines -- 2.1 Dose Personalisation -- 2.2 Multi-drug Combinations -- 2.3 Tailored Release Profiles -- 2.4 Improved Patient Acceptability -- 2.5 On-demand Printing -- 3 Early Phase Drug Development -- 3.1 Pre-clinical Studies and FIH Trials -- 3.2 Motivations for Using 3DP in Early Phase Drug Development -- 3.2.1 Dose Flexibility -- 3.3 Immediate Manufacture -- 3.4 Reduced Resource Investment -- 3.5 Unique Characteristics -- 4 Conclusion -- References -- Chapter 2: 3D Printing Technologies, Implementation and Regulation: An Overview -- 1 Introduction -- 2 Classification of 3D Printing Technologies -- 2.1 Industrial Applications of 3D Printing -- 2.2 3D Printing Software -- 2.3 Binder Jet Printing -- 2.4 Vat Polymerisation -- 2.4.1 Stereolithography -- 2.5 Powder Bed Fusion -- 2.5.1 Selective Laser Sintering -- 2.6 Material Extrusion -- 2.6.1 Fused Deposition Modelling -- 2.6.2 Semisolid Extrusion -- 2.6.3 Bioprinting -- 2.7 Directed Energy Deposition -- 2.8 Sheet Lamination -- 3 3D Printing Implementation in Healthcare -- 3.1 Rapid Administration and Improved Medicine Access -- 3.2 3D Printing and Wearable Diagnostics -- 3.3 Challenges to 3D Printing Implementation -- 4 Regulatory Requirements -- 4.1 Regulatory Considerations of 3D Printing in Pharmaceutics -- 5 Conclusion -- References -- Chapter 3: Binder Jet Printing in Pharmaceutical Manufacturing -- 1 Introduction -- 2 Binder Jet Methodology -- 3 Pharmaceutical Applications of Binder Jet Printing -- 3.1 Controlled-Release Formulations -- 3.2 Rapidly Dissolving Tablets.

The author explores the case of the Israeli pharmaceutical group Teva. It is noted that in modern conditions there are favorable factors for an entry into the global market of the small-and medium-sized pharmaceutical firms producing equivalents of patented drugs. The current global trends such as the growth of living standards increase the number of elderly people, who are the main consumers of medications, and the emergence of new drugs to fight the previously incurable diseases significantly increase the demand for medicines. The total costs of purchasing the drugs are becoming increasingly onerous for patients, for all kinds of involved medical institutions (hospitals, medical offices, insurance funds, etc.) and for the governments. Therefore, there is a growing interest in replacing expensive original drugs by the same quality, but cheaper generics.

Cover -- Copyright -- Table of contents -- Foreword -- Acknowledgements -- Abbreviations -- Executive Summary -- Advances in monitoring can help close the knowledge gap and support policy responses -- Moving towards proactive policy action to curb pharmaceutical pollution -- OECD Policy Recommendations on addressing pharmaceutical residues in freshwater -- Cross-cutting recommendations -- Source-directed recommendations. Pharmaceutical life cycle stages: design, marketing authorisation, manufacturing, post-authorisation -- Use-orientated recommendations. Pharmaceutical life cycle stages: Prescription and use -- End-of-pipe recommendations. Pharmaceutical life cycle stages: collection and disposal, and wastewater treatment and reuse -- 1. Defining the challenge of managing pharmaceuticals in water -- 1.1. Key messages -- 1.2. Introduction -- 1.3. Origins, entry-pathways, sinks and concentration patterns of pharmaceuticals in the environment -- 1.4. Effects of pharmaceuticals in the environment on human and freshwater ecosystem health -- References -- Notes -- 2. Opportunities to build a policy-relevant knowledge base -- 2.1. Key messages -- 2.2. Environmental risk assessment and authorisation of pharmaceuticals -- 2.3. Existing frameworks for monitoring pharmaceuticals in water -- 2.4. Advances in water quality monitoring and potential benefits for risk assessments and water quality policy making -- 2.5. The added value of system modelling -- References -- Notes -- 3. Emerging policy instruments for the control of pharmaceuticals in water -- 3.1. Key messages -- 3.2. Introduction -- 3.3. Source-directed approaches -- 3.4. Use-orientated approaches -- 3.5. End-of-pipe measures -- References -- 4. Recommendations for the management of pharmaceuticals in freshwater.

Multicultural Pharmaceutical Education spotlights methods and theory on how to increase representation of minorities in pharmacy schools and practice settings. Many of the ideas presented in this book are unique, and all provide an opportunity for institutions with few minority students to greatly improve their recruitment and retention efforts geared toward these students. The contributing authors, representing all levels of academia--deans, undergraduate students, vice provosts, executive directors, a National Professor of the Year, and faculty members--have all had experience in s.

This article examines six key issues facing the pharmaceuticals industry that concern the appropriateness and effectiveness of markets, quasi‐markets and regulatory intervention in the sector. The article shows the prevalence of confused thinking in this area, both on the part of lobbyists for the industry and their opponents. It is contended that allowing market forces to operate within a legal or regulatory framework that protects intellectual property rights, promotes innovation and facilitates price competition will produce more socially beneficial outcomes than direct state intervention in the market.

Front Cover -- Contents -- Foreword -- Preface -- Editors -- Contributors -- Chapter 1: Product Life Cycle Management : Stages of New Product Development -- Chapter 2: Principal Concepts in Pharmaceutical Product Design and Development -- Chapter 3: Regulatory and Intellectual Property Aspects during Pharmaceutical Product Development -- Chapter 4: Strategies in Pharmaceutical Product Development -- Chapter 5: Design of Experiments : Basic Concepts and Its Application in Pharmaceutical Product Development -- Chapter 6: Preformulation Studies : Role in Pharmaceutical Product Development