At the core of this book lies the question how to approach medicines, risks and communication as a researcher - or anybody planning and evaluating a communication intervention, or wanting to understand communication events in private and the media. With a view to tackle current shortcomings of communication systems and processes for improved implementation, patient satisfaction and health outcomes, a multilayered approach is presented. This combines multiple data types and methods to obtain a wider and deeper understanding of the major parties and their interactions, as well as the healthcare, social and political contexts of information flows, how they interfere and which impact they have. Illustrated with real life experiences of safety concerns with medicines, worldwide active experts discuss the methods and contributions their disciplines can offer. With considerations on terminologies, tabulated overviews on communication types and outcomes, a patient-centred vision and plain language for non-medical readers, the book creates a platform for multidisciplinary collaborations amongst researchers as well as practitioners from communications, healthcare, the social sciences and pharmacovigilance. Importantly, it advocates for an active role of patients and highlights the achievements and aspirations of patient organisations. Finally, the book suggests establishing an inclusive discipline of humanities and epidemiology of medicinal product risk communication to realise full research potential. The authors are driven by the curiosity for communication as the most human behaviour, and as good health is amongst the basic human needs, medicinal product risk communication is an exciting research field of high global relevance.
Focused on pediatric physiology, pharmacology, pharmacokinetics and pharmacodynamics, this book illustrates the differences between the pediatric population and adults; knowledge of extreme importance not only during pediatric drug development but also in the clinical practice. Physicians, nurses, clinical pharmacologists, researchers and healthcare professionals will find this an invaluable resource. With the advent of pediatric exclusivity, and requirements to conduct clinical studies in children, an emphasis has been placed on finding a safe and efficacious dose of a drug in children. Children are not `small adults', and drug dosing in this population requires special consideration. There are subtle physiological and biochemical differences among neonates, infants, children, adolescents and adults and dosing in pediatrics requires proper understanding of these factors. Furthermore, dosing in children, as in adults, should be based on pharmacokinetic and pharmacodynamic data. This is an evolving area, as pediatric pharmacokinetic studies are becoming mandatory for getting approval of new drugs in this population.
This book, written by leading international experts, provides a comprehensive, current examination of transport-mediated antimicrobial resistance. As a particularly powerful mechanism of multidrug resistance, an in-depth examination of efflux pumps is conducted with bacteria of major public health concern including Enterobacteriaceae, Acinetobacter, Neisseria, Pseudomonas, staphylococci, and mycobacteria. The content spans structural biochemistry and transport mechanisms of the major transporter families and considers individual drug efflux systems across various Gram-positive and Gram-negative species. Genomic analysis of efflux pump distribution and their contribution to clinically-relevant resistance are a major focus of the text. Moreover, interplay between drug efflux pumps and other key resistance mechanisms such as intrinsic drug impermeability, inactivation, and target alterations are discussed, as well as their molecular expression-based regulation and physiological functions beyond resistance, involving biofilms, stress response, and pathogenicity. Finally, strategies are addressed to target this drug resistance mechanism with novel antimicrobials or drug inhibitor adjuvants.
At a time when the field of cardiac safety is going through important changes, this unique book provides the rationale for, and cutting-edge explanations of, new regulatory landscapes that will likely govern cardiac safety assessments globally for the foreseeable future. Exposure-response modeling is already being accepted by regulatory agencies in lieu of the traditional Thorough QT/QTc Study, and the Comprehensive in vitro Proarrhythmia Assay initiative is well under way.
Developments in the field of cardiovascular safety are also described and discussed in the book. These include the search for more efficient ways to exonerate new drugs for type 2 diabetes from an unacceptable cardiovascular liability, how best to address off-target blood pressure increases induced by noncardiovascular drugs, and the continued evolution of the discipline of Cardio-oncology.
"a resource that will likely serve as a standard for years to come" - Dr Jonathan SeltzerTherapeutic Innovation & Regulatory Science, 2017;51(2):180
"I have no hesitation in recommending this book as a valuable reference source" - Dr Rashmi ShahJournal for Clinical Studies, 2017;9(1):62-63
The first of its kind for budget-impact analysis, this comprehensive guide provides clear and concise instructions for evaluating the impact that new pharmaceuticals will have on the budget for a specific jurisdiction. The book demonstrates how to create a budget-impact analysis using a simple six-step process that is consistent with current guidelines for these analyses. Examples and exercises for each chapter afford an opportunity to practice the six-step process in practical applications.
The book progresses from a framework for budget impact analyses to an in-depth review of components and how to develop and present these in software applications and reports. Critical considerations such as uncertainty analysis and validation, and considerations for alternate interventions, such as vaccines and diagnostics, are also covered.
This book is a "must have" for the builder and budget holder, with builders benefiting from instructions to identify and estimate all necessary variables and budget holders receiving a guide to what should be included in the analyses they assess.
Clinically-focussed, with easily accessible tables and chapter summaries suitable for clinicians and researchers, this comprehensive book provides a systematic, critical evaluation of the current literature. An updated clinical decision-making algorithm specifically tailored to the antiretroviral drugs is also provided. The identified interactions are interpreted in the context of known mechanisms derived from clinical, preclinical, and in vitro data. The clinical relevance of the interactions is systematically evaluated and gaps in literature discussed in the context of potential future experiments. In addition to the comprehensive summary of pharmacokinetic and pharmacodynamic drug interactions associated with WHO-recommended antiretroviral drugs on the market today (i.e. nucleotide reverse-transcriptase inhibitors, non-nucleoside reverse-transcriptase inhibitors, integrase inhibitors, and protease inhibitors), this book also provides detailed section summaries on the epidemiology of HIV infection, diagnosis and pharmacotherapy, basic pharmacology of the individual antiretrovirals, pertinent pre-clinical and in vitro molecular pharmacology, and in vitro drug interaction data available in the literature today.
This inclusive work presents a comprehensive update on vaccines for the international traveller.In over 21 chapters, written by leading writers in travel medicine from Australia, New Zealand and Singapore, vaccinology for travel is explained in accessible terms with a focus on practical information. An initial introduction to immunology proceeds into common travel-related diseases and a risk-analysis for acquiring them, followed by vaccine administration techniques and examples of how this knowledge can be applied to the traveller with special risks including children, pregnant women and mass travel. The book also provides a summary of current clinical practice with respect to travel medicine in Australia, New Zealand and Singapore.This straightforward guide to the administration of vaccines for travellers is intended to be the one-stop for the primary healthcare professional needing authoritative practical information speedily. In addition to basic knowledge in vaccinology, guides are offered as to appropriate vaccine recommendations for travel to global regions together with vaccine contents in order to identify any precautions and contraindications.This text presents assessment and management guidelines for common medical presentations to the travel health professional in primary-care health. Easy reference chapters, with practical management parameters for vaccination for travellers, will confidently guide any knowledge acquired permitting self-responsibility in vaccine-preventable disease prevention.
This book compares national and centralised procedure practices and key performance metrics, including current approval times, review practices and pharmacovigilance standards, in the seven Gulf States. Opportunities for an improved regulatory system are identified, which, if fully implemented, could have a significant impact on patients' access to new medicines.The Persian Gulf represents the next growth market for the global biopharmaceutical industry but to date there has been limited information about the regulatory review processes employed in these countries. A thorough examination of the strategies currently being implemented by the Gulf States is considered critical to the future regulatory environment in this region.Pharmaceutical Regulatory Environment: Challenges & Opportunities in the Gulf Region is a must read for those interested in pharmaceutical regulation in the Gulf region.
This book evaluates trends arising in "-Omics" sciences in terms of their current and potential future application to therapeutic design and understanding of disease. Chapters consider the impact of pharmacogenomics and bioinformatics on drug development, as well as trends in genomics, as applied to understanding of neurodegenerative and lung disease, psychiatry and oncology.Following the genome studies released in early part of this century, the advent of the -Omics sciences (genomics and pharmacogenomics, proteomics, metabolomics, transcriptomics) has seen the expansion of a vast knowledgebase with utility in preventing and treating disease, and improving health for all. Bioinformatics and improved pharmacogenetic understanding forge a path for improved drug discovery and design methods accounting for differences in delivery and disposition across populations.
A timely work describing how localized hospital-based health technology assessment (HB-HTA) complements general, `arms-length' HTA agency efforts, and what has been the collective global impact of HB-HTA across the globe. While HB-HTA has gained significant momentum over the past few years, expertise in the field, and information on the operation and organization of HB-HTA, has been scattered. This book serves to bring this information together to inform those who are currently working in the field of HTA at the hospital, regional, national or global level. In addition, this book is intended for decision-makers and policy-makers with a stake in determining the uptake and decommissioning of new and established technologies in the hospital setting. HTA has traditionally been performed at the National/Regional level by HTA Agencies, typically linked to governments. Yet hospitals are the main entry door for most health technologies (HTs). Hospital decision-makers must undertake multiple high stakes investment and disinvestment decisions annually for innovative HTs, usually without adequate information. Despite the existence of arms-length HTA Agencies, inadequate information is available to hospital decision-makers either because relevant HTA reports are not yet released at the time of entry of new technologies to the field, or because even when the report exists, the information contained is insufficient to clarify the contextualized informational needs of hospital decision makers. Therefore, there has recently been a rising trend toward hospital-based HTA units and programs. These units/programs complement the work of National/Regional HTA Agencies by providing the key and relevant evidence needed by hospital decision makers in their specific hospital context, and within required decision-making timelines. The emergence of HB-HTA is creating a comprehensive HTA ecosystem across health care levels, which creates better bridges for knowledge translation through relevance and timeliness.
This book is an essential guide to the medical treatment of thrombosis and presents core principles of anticoagulant therapeutics as well as drug recommendations. Written by recognized experts in the field, this concise, accessible handbook provides a unique and valuable resource in the cardiovascular field, both for those currently in training, and for those already in clinical or research practice.
?This work carefully guides the reader through the methodological, policy and ethical challenges facing health economists conducting research in palliative care. It has collected the opinions of many cutting-edge researchers. Those who design and conduct economic evaluations or economics-related research in end of life populations will find this book thought provoking, instructive and informative. The provision of care to individuals with disorders associated with advancing age, such as cancer and dementia, is an increasing concern amongst policy makers and providers of health and social care. Accordingly, the burden on state and private funders in providing care to patients with these complex illnesses is of growing importance to health economists. However, answering the questions raised by the research community on end of life and palliative care health economics has received little attention. The authors shed light on many questions including: Are economic evaluation methods fit for purpose in patients at the end of life? What is the best way to measure and value health outcomes in this population? What are the appropriate societal rules to govern resource allocation for people at the end of life? Are these people more or less deserving of resources than other patients? Does age matter? How can we define a good death for the purposes of resource allocation decision making? What ethics govern research in end of life patients?
This comprehensive book grants readers exclusive insight into current advancements in the field of osteoarthritis (OA). Contributions from leading scientists and clinicians provide a detailed introduction into current understanding of the pathogenesis of OA, different joint structures affected by this debilitating disease (hip, knee, elbow, shoulder, foot, ankle, hand, wrist, and spine), current knowledge and practice in imaging, joint conservative strategies, OA biomarkers as well as currently available treatments, their safety profile and future therapeutic targets. This book further discusses the potential of regenerative therapies and recent advances in OA Personalized Medicine, and how collection of OA patient's phenotypic, genetic and proteomic data is able to direct treatment strategies through Bio-Informatics.
The biologics market continues to witness an impressive rate of growth and the monoclonal antibody market, in particular, has contributed remarkably to the expansion of this segment within the pharmaceutical industry. In 2006, close to 80% of the annual biologics growth rate in the United States (US) was attributed to cancer and anti-TNF antibodies, with increases in growth of 56% and 25%, respectively, compared to those in the previous year. Additionally, the monoclonal antibody sector is anticipated to achieve a growth rate of approximately 14% by 2012, easily outstripping the predicted 0.6% growth rate in the small molecules market. The robust late-stage antibody pipeline within the biotech sector has drawn an increasing amount of interest from the large pharmaceutical industry and has triggered the largest product and platform deals in 2006, with values more than $2.1 and $5.1 billion in partnering and mergers and acquisitions, respectively. Additionally, with the forthcoming emergence of biogenerics, next-generation bio-improved antibodies have drawn much attention and increasingly contribute to the growth of the biologics segment. As next-generation monoclonal antibodies confront their first-generation rivals, it is critical that these next-generation products offer a clear differentiating advantage against the existing competition.
Successful strategies for the development of monoclonal antibodies require integration of knowledge with respect to target antigen properties, antibody design criteria such as affinity, isotype selection, Fc domain engineering, pharmacokinetic and pharmacodynamic (PK/PD) properties, antibody cross-reactivity across species, market differentiation opportunities for the first- and next-generation leads, and regulatory requirements from the early stages of antibody development. Biophysical measurements are one of the critical components necessary for the design of effective translational strategies for lead selection and evaluation of relevant animal species for preclinical safety and efficacy studies. Incorporation of effective translational strategies from the early stages of the antibody development process is a necessity, and when considered, it not only reduces development time and cost, but also fosters implementation of rational decision-making throughout all phases of antibody development.
Translational strategies for development of antibody-based therapeutics should allow understanding of the relationship between the `unit dose' and `unit effect' with respect to both beneficial and deleterious effects from early stages of development. The flow of information from later to earlier stages of development should provide opportunities to facilitate selection of more effective and novel next-generation drug candidates. Selection and evaluation of relevant biomarkers in early preclinical development in "relevant" animal models should allow for identifying potential risks to humans and establishing safe First-In-Human (FIH) dosing strategies. Hence, integration of knowledge with respect to target antigen properties such as antigen distribution, expression profile, kinetic properties, target pharmacology, antigen isoforms and pharmacological redundancy in health and disease, as well as antibody design criteria, such as antibody isotype, affinity, PK/PD and safety is a critical necessity for the design of effective translational strategies. Additionally, these factors will further offer critical differentiating characteristics for next-generation antibodies, and novel technologies prove instrumental in generation of bio-improved antibody candidates for market entry.
This book will examine many important considerations necessary for the design of effective translational strategies during the development of antibody-based therapeutics.
Representing a state-of-the-art appraisal of this viral infection and its complications, this book comprises contributions from international authorities in infectious diseases, varicella-voster virus infections, and neuropathic pain. Important new information is presented on the role of the virus in terms of vascular risk, notably in heart attack, stroke and granulomatous angiitis (temporal arteritis). Similarly, new information on gastrointestinal involvement, often in the absence of rash and as seen with vasculopathies, is covered. The reader will benefit from new research into the pathology, pathophysiology and treatment of postherpetic neuralgia and its complications, and special attention is paid to prevention through zoster vaccination using the current zoster vaccine, and a novel, broader option that can be used in immunocompromised patients.This book follows the two editions of the book, Herpes Zoster and Postherpetic Neuralgia, and is divided into sections for the convenience of the reader. A section on herpes zoster includes epidemiology and natural history of the varicella zoster virus, herpes zoster ophthalmicus, neurological complications, the role of varicella zoster virus in giant cell arteritis, concern about increased vascular risk of heart attack and stroke, antiviral therapy, and treatment of skin manifestations. A section on postherpetic neuralgia includes important information on the effect of herpes zoster and postherpetic neuralgia on quality of life, the neuropathology and pathophysiological mechanisms in postherpetic neuralgia, and the new concept of persistent ganglionitis as the cause of postherpetic neuralgia. A comparison is made between facial postherpetic neuralgia and trigeminal neuralgia. There is an extensive section on treatment, including the role of opioids, the general treatment of postherpetic neuralgia, intervention and neurosurgical approaches, and covering guidelines for clinical trial designs in postherpetic neuralgia. A final section addresses the questions of whether aggressive treatment of acute herpes zoster can prevent postherpetic neuralgia and includes a critically important chapter on herpes zoster vaccines.
This book provides a robust set of health economic principles and methods to inform societal decisions in relation to research, reimbursement and regulation (pricing and monitoring of performance in practice). We provide a theoretical and practical framework that navigates to avoid common biases and suboptimal outcomes observed in recent and current practice of health economic analysis, as opposed to claiming to be comprehensive in covering all methods. Our aim is to facilitate efficient health system decision making processes in research, reimbursement and regulation, which promote constrained optimisation of community outcomes from a societal perspective given resource constraints, available technology and processes of technology assessment. Importantly, this includes identifying an efficient process to maximize the potential that arises from research and pricing in relation to existing technology under uncertainty, given current evidence and associated opportunity costs of investment. Principles and methods are identified and illustrated across health promotion, prevention and palliative care settings as well as treatment settings. Health policy implications are also highlighted.
This resource guides prescribers, pharmacists, and regulators with an update on the recent expansion of basic and clinical knowledge that forms a framework for understanding cutaneous reactions. This understanding will lead, in turn, to better outcomes and decisions in treatment and management, both in the clinic and in the life cycle of drug development.
The skin is a common target for adverse drug events and even mild rashes can be part of life-threatening syndromes. Patients and practitioners often face important decisions about therapy after a drug eruption, including treatment, cross-reactivity with future pharmaceuticals, genetic considerations and dealing with long-term sequelae after a reaction. An international team of experts and leaders in the field share their story and insights into the scientific details and relevant clinical context.
This book provides unique insights into the issues that drive modified dosing regimens for antibiotics in the critically ill. Leading international authors provide their commentary alongside a summary of existing evidence on how to effectively dose antibiotics. Severe infection frequently necessitates admission to the intensive care unit (ICU). Equally, nosocomial sepsis often complicates the clinical course in ICU. Early, appropriate application of antibiotic therapy remains a cornerstone of effective management. However, this is challenging in the critical care environment, given the significant changes in patient physiology and organ function frequently encountered. Being cognisant of these factors, prescribers need to consider modified dosing regimens, not only to ensure adequate drug exposure, and therefore the greatest chance of clinical cure, but also to avoid encouraging drug resistance.
This book will provide an introduction to the epidemiology, etiology and pathogenesis of the condition while also exploring the classification, diagnosis, and current and emerging therapies for systemic lupus erythematosus. Systemic lupus erythematosus is an autoimmune disease in which the body's immune system mistakenly attacks healthy tissue. It can affect the skin, joints, kidneys, brain, and other organs. The underlying cause of the disease is not fully known, and SLE is much more common in women than in men. It may occur at any age but most often occurs in people between 10 and 50 years of age. This is the second Adis title from Ronald F van Vollenhoven, who previously authored Biologics for the Treatment of Rheumatoid Arthritis.
In the past decade there has been a worldwide evolution in evidence-based medicine that focuses on real-world Comparative Effectiveness Research (CER) to compare the effects of one medical treatment versus another in real world settings. While most of this burgeoning literature has focused on research findings, data and methods, Howard Birnbaum and Paul Greenberg (both of Analysis Group) have edited a book that provides a practical guide to decision making using the results of analysis and interpretation of CER. Decision Making in a World of Comparative Effectiveness contains chapters by senior industry executives, key opinion leaders, accomplished researchers, and leading attorneys involved in resolving disputes in the life sciences industry. The book is aimed at 'users' and 'decision makers' involved in the life sciences industry rather than those doing the actual research. This book appeals to those who commission CER within the life sciences industry (pharmaceutical, biologic, and device manufacturers), government (both public and private payers), as well as decision makers of all levels, both in the US and globally.
Comprising a single repository of knowledge and scientific evidence in the field, this book provides strategies to mitigate fall risk by providing information on the complex interactions between aging processes, co-morbid conditions and prescribed medications in older patients.
Geriatric health is becoming a more prominent issue as the population ages, and balancing the beneficial effects of medication against the potential and real side-effects in these patients involves a deliberate and thoughtful task: physiologic aging, the accumulation of co-morbidities, and the use of drugs to manage various conditions and symptoms generates a unique set of problems for each patient.
Falls are a dreaded event in older people. The event can affect a person in a physical, and psychological manner, resulting in soft tissue and bony injury, fear of falling, and depression. The identification of and reduction in fall risks in older people is a worldwide concern, and reducing the incidence of falls is a ubiquitous quality measure of health care delivery. Heterogeneity amongst older people precludes a single solution. However, physicians and others involved in the care of geriatric patients will benefit from the presented insights into how medication use can be modified to limit its impact as a contributing factor.
A comprehensive and granular insight into the challenges of promoting rational medicine, this book serves as an essential resource for health policy makers and researchers interested in national medicines policies. Country-specific chapters have a common format, beginning with an overview of the health system and regulatory and policy environments, before discussing the difficulties in maintaining a medicines supply system, challenges in ensuring access to affordable medicines and issues impacting on rational medicine use. Numerous case studies are also used to highlight key issues and each chapter concludes with country-specific solutions to the issues raised. Written by highly regarded academics, the book includes countries in Africa, Asia, Europe, the Middle East and South America.
This book serves as a roadmap for the development and application of patient-reported outcome (PRO) measures, supporting beginners through to experts, as a practical guide. To elucidate on key concepts in the book, examples from clinical research in hyperhidrosis and health-related quality of life and medicines clinical development context, are used. Health-related quality of life represents one of the most commonly measured PROs in both routine clinical practice and research. The book demonstrates the importance of PROs to patients with chronic disease and how such outcomes can assist clinicians in managing patients and monitoring their response to treatment in terms of both symptoms and impacts.
This book will benefit readers as a single-source practical guide on the development of modern PRO measures and may also serve as a blueprint for the conceptualization and planning of evidence generation related to PROs in various settings. Ideas and suggestions on how to navigate recent developments shaping the field of PRO measurement are also offered.
This book is intended to communicate current best practice in pediatric clinical pharmacology and clinical pharmacy with special consideration of the prevailing circumstances and most pressing needs in developing countries. It also addresses measures that may be taken in countries with emerging economies through organizational and political adjustments to reduce unacceptable levels of morbidity and mortality among children and pregnant women with treatable diseases.