Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally.

Medicine Price Surveys, Analyses and Comparisons establishes guidelines for the study and implementation of pharmaceutical price surveys, analyses, and comparisons. Its contributors evaluate price survey literature, discuss the accessibility and reliability of data sources, and provide a checklist and training kit on conducting price surveys, analyses, and comparisons. Their investigations survey price studies while accounting for the effects of methodologies and explaining regional differences in medicine prices. They also consider policy objectives such as affordable access to medicines and cost-containment as well as options for improving the effectiveness of policies.

Equipment Qualification in the Pharmaceutical Industry provides guidance and basic information for the preparation of a quality qualification program. It has been noted that there is a general lack of understanding in the industry, especially for those new to the industry, as to what constitutes a compliant qualification program. Even experienced professionals have felt a lack of security in reaching a compliant state. This book outlines a guideline for the preparation and execution of qualification protocols including the installation (IQ), operational (OQ), and performance (PQ) protocols. It discusses the importance of related qualification programs (e.g., quality systems, commissioning, computer system, and cleaning) and how to incorporate them into a fully compliant qualification program. Furthermore, it provides matrices of what could be included in each type of protocol for major types of process equipment. While primarily for people entering the pharmaceutical industry, those established in the field will benefit from the multiple examples and matrices as well as integration of related systems. Equipment Qualification in the Pharmaceutical Industry provides students and pharmaceutical scientists a guideline for the preparation and execution of qualification (installation, operational, and performance) protocols.

Nanotechnology in Ophthalmology is a comprehensive and up-to-date reference on the role and applications of nanotechnology in ophthalmology, from drug delivery and treatment of ocular diseases to toxicity issues. Written by experts from the nanotechnology, ophthalmology, and pharmacology fields, this book has a unique, broad and diverse scope, including chapters on nanosensor-based diagnostic tools, delivery of nanobiomaterials, implantable materials and devices, delivery of nanobiomaterials, nanotechnology for medical and surgical treatment, regenerative medicine, and more. This book provides a valuable reference to researchers working in the areas of ophthalmology, nanoscience and pharmacology, and clinical fellows who are interested in nanoophthalmology as a reference for their practice and research.

This invaluable volume serves as a guide to up-to-the-minute techniques for the discovery and evaluation of pharmacologically active compounds for therapeutic development. Focusing on practical applications, provided by expert practitioners from both industry and academic research laboratories, Advances in Drug Discovery Techniques covers rational drug design, high-throughput screening and genetic approaches to drug discovery. Moreover, chapters also focus on advances in the use of combinatorial chemistry and natural products, both of which support the chemical diversity for many drug screening programmes. Typical screening studies and their link to robotics and informatics are also presented in detail, together with an overview of current progress within antisense therapeutics. Overall, this book will be an excellent reference source for all individuals interested in making sense of the rapid changes in drug discovery that result from developments in molecular biology, robotics and informatics.

Covers advances in particulate drying and its importance in the process industry Highlights recent developments in conventional drying techniques and new drying technologies Helps readers gain insight into selecting the appropriate drying techniques for a particular product Summarizes various applications from a wide range of industries, including chemical, food, pharma, biotech, polymer, mineral, and agro-industries Envisages future research trends and demands in particulate drying

This book discusses and chronicles various types of manufacturing processes, including casting and molding, machining, joining, shearing, and forming. It refers to repetitive, discrete, job shop, process manufacturing (continuous), and process manufacturing (batch). It also offers detailed examples from the nuclear, electronic, plastics, adhesives, inks, packaging, chemical, and pharmaceutical industries. Advanced Manufacturing Operations Technologies: Principles, Applications, and Design Correlations in Chemical Engineering Fields of Practice fills the gap in the connection between production and regulated applications in several industries. It highlights established concepts and provides a new fresh outlook by concentrating on and creating linkages in the implementation of practices in manufacturing and safe clean energy systems. Case studies for the overall design, installations, and construction of manufacturing operations in various industries as well as the standard operating procedures are offered. The book also discusses the correlation between design strategies including step-by-step processes to ensure the reliability, safety, and efficacy of products. The fundamentals of controlled techniques, quality by design, risk assessment, and management are covered in support of operations applications and continuous improvement. This comprehensive book is helpful to all professionals, students, and academicians in many scientific disciplines that utilize fundamental principles of chemical engineering. It is engineering-driven and will be of use to those in industrial and manufacturing, chemical, biochemical, mechanical engineering, and automated control systems fields.

Power Recruiting unfolds the mystery of how to effectively recruit for every industry. Diana Y. Ji is the founder and president of Bongene Search, an executive search firm dedicated to handling critical talent search needs in the biopharma industry. In Power Recruiting, she brings her twenty years of experience in corporate talent acquisition and executive search fields to teach hiring managers and recruiting professionals: The key to finding top talents and getting them onboard How to identify a good hire and avoid the bad ones The best strategies to make their company more attractive to potential hires Guarantee a successful hire every time Tips to getting ahead in the hiring game

India is the largest provider of generic drugs globally. The Indian pharmaceutical sector supplies over 50 per cent of the global demand for various vaccines, and as a result, holds an important position in the global pharmaceutical sector. This book is a comprehensive study of pharmaceutical marketing management in the Indian context and similar growth markets. The book introduces the fast-paced and multi-faceted discipline of pharmaceutical marketing management through an in-depth discussion on the genesis and evolution of its marketing concept. Combining theory and practice, it offers a strategic approach to pharmaceutical marketing from an organisational and business perspective and explicates the practical applications of it. Richly supported by case studies, the book brings together fresh perspectives and approaches equally useful for students and professionals. This book will be of interest to academicians, advanced students, and practitioners of pharmaceutical marketing and pharmaceutical management. It will also be beneficial to those interested in business strategy, decision making, and international marketing.

India is the largest provider of generic drugs globally. The Indian pharmaceutical sector supplies over 50 per cent of the global demand for various vaccines, and as a result, holds an important position in the global pharmaceutical sector. This book is a comprehensive study of pharmaceutical marketing management in the Indian context and similar growth markets. The book introduces the fast-paced and multi-faceted discipline of pharmaceutical marketing management through an in-depth discussion on the genesis and evolution of its marketing concept. Combining theory and practice, it offers a strategic approach to pharmaceutical marketing from an organisational and business perspective and explicates the practical applications of it. Richly supported by case studies, the book brings together fresh perspectives and approaches equally useful for students and professionals. This book will be of interest to academicians, advanced students, and practitioners of pharmaceutical marketing and pharmaceutical management. It will also be beneficial to those interested in business strategy, decision making, and international marketing.

FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label.

Trail-blazing social entrepreneurs are tackling the world's most pressing problems that government, business, or charity have failed to solve. They are creating businesses with a primary mission of social change. Scott Boyer is one such social entrepreneur. This 28-year veteran of Big Pharma left a six-figure salary to start OWP Pharmaceuticals and the ROW Foundation. This commercial business and non-profit organization exist in a symbiotic relationship we call a "tandem hybrid social enterprise." This model combines a multimillion dollar business with a foundation that's on track to become the largest funder of projects serving people with epilepsy and associated psychiatric disorders in the world. The tandem hybrid incorporates the principles learned by Scott and others for building a truly unique social enterprise from the ground up; one that is: Driven by a compelling social mission Financed by commercial success Structured to retain control Scalable and sustainable for the long haul Powering Social Enterprises With Profit And Purpose offers a detailed blueprint that has proven commercially and philanthropically successful and that can be replicated in most business sectors.

Nanotechnology-Based Approaches for Targeting and Delivery of Drugs and Genes provides an overview of the important aspects of nanomedicine in order to illustrate how to design and develop novel and effective drug delivery systems using nanotechnology. The book is organized into three sections, beginning with an introduction to nanomedicine and its associated issues. Section two discusses the latest technologies in nanomedicine, while the third section covers future developments and challenges in the field. By focusing on the design, synthesis, and application of a variety of nanocarriers in drug and gene delivery, this book provides pharmaceutical and materials science students, professors, clinical researchers, and industry scientists with a valuable resource aimed at tackling the challenges of delivering drugs and genes in a more targeted manner.

Trail-blazing social entrepreneurs are tackling the world's most pressing problems that government, business, or charity have failed to solve. They are creating businesses with a primary mission of social change. Scott Boyer is one such social entrepreneur. This 28-year veteran of Big Pharma left a six-figure salary to start OWP Pharmaceuticals and the ROW Foundation. This commercial business and non-profit organization exist in a symbiotic relationship we call a "tandem hybrid social enterprise." This model combines a multimillion dollar business with a foundation that's on track to become the largest funder of projects serving people with epilepsy and associated psychiatric disorders in the world. The tandem hybrid incorporates the principles learned by Scott and others for building a truly unique social enterprise from the ground up; one that is: Driven by a compelling social mission Financed by commercial success Structured to retain control Scalable and sustainable for the long haul Powering Social Enterprises With Profit And Purpose offers a detailed blueprint that has proven commercially and philanthropically successful and that can be replicated in most business sectors.

Market access is the fourth hurdle in the drug development process and the primary driver for global income of any new drug. Without a strategy in place for pricing, showing value for effectiveness and an understanding of the target purchasers' needs, the drug will fail to reach its intended market value. Introduction to Market Access for Pharmaceuticals is based on an accredited course in this area, taken from the European Market Access University Diploma (EMAUD), and is affiliated with Aix Marseille University. Key Features: The first guide to market access for pharmaceuticals based on tested teaching materials Addresses both pharmaceutical and vaccine products Includes case studies and scenarios Covers market access consdierations for Western Europe, the USA, Japan and China Explains the impact the changing healthcare market will have on your product

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors - states, transnational business corporations, or civil society groups - and their influence on the structures - such as national and international agreements, organizations, and private entities - that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.

The pharma and medtech sectors are evolving rapidly, driven by science, technology, economics, politics and globalization. In the new industry landscape, creating strong brand strategies is ever more difficult and ever more vital. Brand Therapy gives pharma and medtech brand teams the tools to understand their market, create strong strategies and translate them into actionable plans. Written in 16 short, easy chapters, it is essential reading for anyone who works in or with brand teams in the life sciences industry.

This book examines an important phenomenon for competitiveness and innovation in industry: namely the growing use of scientific principles in industrial research. Industrial innovation still arises from systematic trial-and-error experiments with many designs and objects, but these experiments are being guided by a more rational understanding of phenomena. This has important implications for market structure, firm strategies and competition. Science and Innovation focuses on the pharmaceutical industry. It discusses the changes that the notable advances in the life sciences since the 1980s have exerted on the strategies of drug companies, the organization of their internal research, their relationships with scientific institutions, the division of labour between large pharmaceutical firms and small research-intensive suppliers, the productivity of drug discovery and the productivity of R & D.

This book presents the findings of systematic research into the healthcare medicine management policies of China. In-depth comprehensive research has been carried out, targeting multiple issues of particular importance in healthcare medicine management, such as the purchasing, pricing, payment, usage, and the function of commercial healthcare insurance in medical payment. The book goes on to put forward policy advice regarding the aforementioned issues.

The Life-Cycle of Pharmaceuticals in the Environment identifies pathways of entry of pharmaceuticals into the environment, beginning with the role of global prescribing and disposal practices. The book then discusses typical levels of common pharmaceuticals and how they can be determined in natural waters such as raw and treated sewage, and in potable water. In addition, sections examine methods currently available to degrade pharmaceuticals in natural waters and some of their ecotoxicological impacts, along with future considerations and the growing concept of product stewardship.

Provides a comprehensive review of challenges and opportunities as related to the applications of big data, AI, and machine learning in the entire spectrum of drug R&D Discusses regulatory developments in leveraging big data and advanced analytics in drug review and approval Offers a balanced approach to data science organization build Presents real-world examples of AI-powered solutions to a host of issues in the lifecycle of drug development Affords sufficient context for each problem and provides detailed description of solutions suitable for practitioners with limited data science expertise

For most Western audiences, Cuba is a touristic paradise stuck in time and virtually detached from world technology networks by the US embargo - anything but a hub of industrial innovation and high value-added biotechnology. However, a closer look reveals more subtle but equally powerful stories that challenge the homogenizing assumptions of conventional economics and open up scope for more sophisticated reflections on Cuban economy and industry. From this kind of enquiry emerges the case of the internationally respected Cuban biotech industry as the most successful case of science and technology policy in the country's economic history. The book takes an interdisciplinary approach, exploring issues such as interdependency, purpose and history as natural constituencies of the innovation process. It also examines the dynamic and crucial role played by the state in the formation of innovative business enterprises. This book will be of interest to academic researchers in the fields of innovation and economic development.

Merck and the pharmaceutical industry are headline news today. Controversies over public safety, prices, and the ability of the industry to develop the new drugs and vaccines that society needs have been covered worldwide. Roy Vagelos, who was head of research and then CEO at Merck from the mid-1970s through the early 1990s, addresses these issues here. Success with targeted research started Merck on a path that would lead to a series of block-buster therapies that carried the firm to the top of the global industry in the 1990s and Vagelos into the top position at the company. Trained as a physician and scientist, he had to learn how to run a successful business while holding to the highest principles of ethical behavior. He was not always successful. He and his co-author explain where and why he failed to achieve his goals and carefully analyze where he succeeded.

This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

This book provides an understanding of what is required to engineer and manufacture drug products. It bridges established concepts and provides for a new outlook by concentrating and creating new linkages in the implementation of manufacturing, quality assurance, and business practices related to drug manufacturing and healthcare products. This book fills a gap by providing a connection between drug production and regulated applications. It focuses on drug manufacturing, quality techniques in oral solid dosage, and capsule filling including equipment and critical systems, to control production and the finished products. The book offers a correlation between design strategies and a step-by-step process to ensure the reliability, safety, and efficacy of healthcare products. Fundamentals of techniques, quality by design, risk assessment, and management are covered along with a scientific method approach to continuous improvement in the usage of computerized manufacturing and dependence on information technology and control operations through data and metrics. Manufacturing and Quality Assurance of Oral Pharmaceutical Products: Processing and Safe Handling of Active Pharmaceutical Ingredients (API) is of interest to professionals and engineers in the fields of manufacturing engineering, quality assurance, reliability, business management, process, and continuous improvement, life cycle management, healthcare products manufacturing, pharmaceutical processing, and computerized manufacturing.