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Books > Business & Economics > Industry & industrial studies > Manufacturing industries > Pharmaceutical industries
Basic Fundamentals of Drug Delivery covers the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable drug delivery system. The book also covers various approaches involved in optimizing the therapeutic performance of a biomolecule while designing its appropriate advanced formulation.
The pharmaceutical industry is broken. From the American hedge fund manager who hiked the price of an AIDS pill from $17.50 to $750 overnight to the children's cancer drugs left intentionally to expire in a Spanish warehouse, the signs of this dysfunction are all around. A system that was designed to drive innovation and patient care has been relentlessly distorted to drive up profits. Medicines have become nothing more than financial assets. The focus of drug research, how drugs are priced and who has access to them is now dictated by shareholder value, not the good of the public. Drug companies fixated on ever-higher profits are being fined for bribing doctors and striking secret price-gouging deals, while patients desperate for life-saving medicines are driven to the black market in search of drugs that national health services can't afford. Sick Money argues that the way medicines are developed and paid for is no longer working. Unless we take action we risk a dramatic decline in the pace of drug development and a future in which medicines are only available to the highest bidder. In this book investigative journalist Billy Kenber offers a diagnosis of an industry in crisis and a prescription for how we can fight back.
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.
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.
Nanostructures for Oral Medicine presents an up-to-date examination of the applications and effects of nanostructured materials in oral medicine, with each chapter addressing recent developments, specific applications, and uses of nanostructures in the oral administration of therapeutic agents in dentistry. The book also includes coverage of the biocompatibility of nanobiomaterials and their remarkable potential in improving human health and in reducing environmental pollution. Emerging advances, such as Dr. Franklin Tay's concept of a new nanotechnology process of growing extremely small, mineral-rich crystals and guiding them into the demineralized gaps between collagen fibers to prevent the aging and degradation of resin-dentin bonding is also discussed. This work will be of great value to those who work in oral medicine, providing them with a resource to gain a greater understanding of how nanotechnology can help them create more efficient, cost-effective products. In addition, it will be of great interest to those who work in materials science who wish to gain a greater appreciation of how nanostructured materials are applied in this field.
In pharmaceutical patent law, the problem of lack of policy direction and inappropriate legal framework is widespread - particularly among jurisdictions with little to no pharmaceutical research or manufacturing. This book aims to inform public policy and influence debate through a comprehensive review of Hong Kong's pharmaceutical patent law. By demonstrating the need for a holistic review of pharmaceutical patent laws and evaluating Hong Kong's system in light of health policy, economic and social factors, Bryan Mercurio recommends changes to the legal framework and constructs a more efficient and effective system for Hong Kong. He thoroughly evaluates the international framework and best practice models to offer a global perspective to each issue before providing local context in the analysis. While the focus of the book is Hong Kong, the analysis on pharmaceutical patent law and policy extends to other jurisdictions facing issues on reforming their national system.
Advances and Avenues in the Development of Novel Carriers for Bioactives and Biological Agents provides sound data on the utility of biological and plant-based drugs and describes challenges faced in all aspects offering indispensable strategies to use in the development of bioactive medicines. Bioactive based medications are commonly used throughout the world and have been recognized by physicians and patients for their therapeutic efficacy. Bioactive formulations, including their subordinates and analogs, address 50% of all medicines in clinical practice. Novel bioactive medicine transporters can cure many disorders by both spatial and transitory approaches and have various justifications in medicinal potential. This book presents information on the utility of natural, plant, animal and bioengineered bioactive materials. It is a fundamental source of information and data for pharmacognosists, pharmaceutical analysts, drug transport scientists and pharmacologists working in bioactive medications.
Drug Design and Discovery in Alzheimer's Disease includes expert reviews of recent developments in Alzheimer's disease (AD) and neurodegenerative disease research. Originally published by Bentham as Frontiers in Drug Design and Discovery, Volume 6and now distributed by Elsevier, this compilation of the sixteen articles, written by leading global researchers, focuses on key developments in the understanding of the disease at molecular levels, identification and validation of molecular targets, as well as innovative approaches towards drug discovery, development, and delivery. Beginning with an overview of AD pharmacotherapy and existing blockbuster drugs, the reviews cover the potential of both natural and synthetic small molecules; the role of cholinesterases in the on-set and progression of AD and their inhibition; the role of beta-site APP clearing enzyme-1 (BACE-1) in the production of ss-amyloid proteins, one of the key reasons of the progression of AD; and other targets identified for AD drug discovery.
The dean of business historians continues his masterful chronicle of the transforming revolutions of the twentieth century begun in "Inventing the Electronic Century," Alfred Chandler argues that only with consistent attention to research and development and an emphasis on long-term corporate strategies could firms remain successful over time. He details these processes for nearly every major chemical and pharmaceutical firm, demonstrating why some companies forged ahead while others failed. By the end of World War II, the chemical and pharmaceutical industries were transformed by the commercializing of new learning, the petrochemical and the antibiotic revolutions. But by the 1970s, chemical science was no longer providing the new learning necessary to commercialize more products, although new directions flourished in the pharmaceutical industries. In the 1980s, major drug companies, including Eli Lilly, Merck, and Schering Plough, commercialized the first biotechnology products, and as the twenty-first century began, the infrastructure of this biotechnology revolution was comparable to that of the second industrial revolution just before World War I and the information revolution of the 1960s. "Shaping the Industrial Century" is a major contribution to our understanding of the most dynamic industries of the modern era.
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.
Nucleic Acids as Gene Anticancer Drug Delivery Therapy highlights the most recent developments in cancer treatment using nucleic acids, nanoparticles and polymer nanoparticles for genomic nanocarriers as drug delivery, including promising opportunities for targeted and combination therapy. The development of a wide spectrum of nanoscale technologies is beginning to change the scientific landscape in terms of disease diagnosis, treatment, and prevention. This book presents the use of nanotechnology for medical applications, focusing on its use for anticancer drug delivery. Various intelligent drug delivery systems such as inorganic nanoparticles and polymer-based drug delivery are discussed. The use of smart drug delivery systems seems to be a promising approach for developing intelligent therapeutic systems for cancer immunotherapies and is discussed in detail along with nucleic acid-targeted drug delivery combination therapy for cancer. Nucleic Acids as Gene Anticancer Drug Delivery Therapy will be a useful reference for pharmaceutical scientists, pharmacologiests, and those involved in nanotechnology and cancer research.
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.
"The Future of Drug Discovery: Who decides which diseases to
treat?" provides a timely and detailed look at the efforts of the
pharmaceutical industry and how they relate, or should relate, to
societal needs. The authors posit that as a result of increasing
risk aversion and accelerated savings in research and development,
the industry is not developing drugs for increasingly prevalent
diseases, such as Alzheimer s disease, untreatable pain,
antibiotics and more. This book carefully exposes the gap between
the medicines and therapies we need and the current business path.
By analyzing the situation and discussing prospects for the next
decade, the "The Future of Drug Discovery" is a timely book for all
those who care about the development needs for drugs for
disease. This thought-provoking book is the first to: provide an in-depth, broad perspective on the crisis in drug industry expose the disconnect between what society needs and what the drug companies are working on analyse and project over 10 years into the future explain what it means for scientists and society determine what is needed to be done to make sure that the industry responds to society's needs, remains commercially attractive and answers the question as to who decides which diseases to treat"
Quality assurance is necessary to maintain quality and services in
the pharmaceutical and life science industries. Quality assurance
demonstrates that the logic and practice of problem solving can
integrate both program efficacy and regulatory compliance. This
title is divided into three parts; the first part discusses the
process by which a problem in regulated industry is identified, for
example a manufacturing deviation that leads to an adulterated drug
product, and reviews the decision-making steps involved in
remedying the problem. The second part delves into the staff
training requirements of procedures that are thereby revised. The
third part expands on this discussion by considering piloting the
proposed training module, preparing assessments of trainee
proficiency, evaluating the training module, including integrating
rigorous evaluative designs with formative program improvement, and
documenting the entire effort.
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.
Dosage Form Design Parameters, Volume I, examines the history and current state of the field within the pharmaceutical sciences, presenting key developments. Content includes drug development issues, the scale up of formulations, regulatory issues, intellectual property, solid state properties and polymorphism. Written by experts in the field, this volume in the Advances in Pharmaceutical Product Development and Research series deepens our understanding of dosage form design parameters. Chapters delve into a particular aspect of this fundamental field, covering principles, methodologies and the technologies employed by pharmaceutical scientists. In addition, the book contains a comprehensive examination suitable for researchers and advanced students working in pharmaceuticals, cosmetics, biotechnology and related industries.
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.
From prolonged duration of a disease, to permanent injury, to death, drug shortages have led to harmful outcomes for patients of all ages. Over the last decade, an increasing number of prescription drugs -- including life-saving and life-sustaining drugs -- have been in short supply, preventing health care providers and patients from accessing medications that are essential for treatment. During shortages, providers -- including hospitals, physicians, and pharmacists -- may have to use medications that could be less effective for treating conditions or carry unwanted side-effects, if alternatives are available at all. The immediate cause of drug shortages can generally be traced to a manufacturer halting or slowing production to address quality problems, triggering a supply disruption. Other manufacturers have a limited ability to respond to supply disruptions due to constrained manufacturing capacity. This book reviews the trends in recent drug shortages and describes what is known about their effect on patients and providers; examines the causes of drug shortages; and evaluates the progress FDA has made in addressing drug shortages.
An expert's view on solving the challenges confronting today's pharmaceutical industry Author John LaMattina, a thirty-year veteran of the pharmaceutical industry and former president of Pfizer's Global R&D Division, is internationally recognized as an expert on the pharmaceutical industry. His first book, "Drug Truths: Dispelling the Myths About Pharma R&D, " was critically acclaimed for clearing up misconceptions about the pharmaceutical industry and providing an honest account of the contributions of pharmaceutical research and development to human health and well-being. As he toured the country discussing "Drug Truths, " Dr. LaMattina regularly came across people who were filled with anger, accusing the pharmaceutical industry of making up diseases, hiding dangerous side effects, and more. This book was written in response to that experience, critically examining public perceptions and industry realities. Starting with "4 Secrets that Drug Companies Don't Want You to Know," "Devalued and Distrusted" provides a fact-based account of how the pharmaceutical industry works and the challenges it faces. It addresses such critical issues as: Why pharmaceutical R&D productivity has declinedWhere pharmaceutical companies need to invest their resourcesWhat can be done to solve core health challenges, including cancer, diabetes, and neurodegenerative diseasesHow the pharmaceutical industry can regain public trust and resuscitate its image Our understanding of human health and disease grows daily; however, converting science into medicine is increasingly challenging. Reading "Devalued and Distrusted, " you'll not only gain a greater appreciation of those challenges, but also the role that the pharmaceutical industry currently plays and can play in solving those challenges.Get to know the author: Read an interview with John LaMattina or watch a video on ChemistryViews Interview: John LaMattina: 30 Years in PharmaVideo: Can the Pharmaceutical Industry Restory its Broken Image?
A free open access ebook is available upon publication. Learn more at www.luminosoa.org. Capitalizing a Cure takes readers into the struggle over a medical breakthrough to investigate the power of finance over business, biomedicine, and public health. When curative treatments for hepatitis C launched in 2013, sticker shock over their prices intensified the global debate over access to new medicines. Weaving historical research with insights from political economy and science and technology studies, Victor Roy demystifies an oft-missed dynamic in this debate: the reach of financialized capitalism into how medicines are made, priced, and valued. Roy's account moves between public and private labs, Wall Street and corporate board rooms, and public health meetings and health centers to trace the ways in which curative medicines became financial assets dominated by strategies of speculation and extraction at the expense of access and care. Provocative and sobering, this book illuminates the harmful impact of allowing financial markets to determine who heals and who suffers and points to the necessary work of building more equitable futures.
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