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
This concise, yet practical handbook will aid in supporting the diagnosis, treatment, and long-term management of autism, including behavioral therapies, current clinical trials, and emerging pharmaceutical treatments. Autism spectrum disorder (ASD) is a developmental disorder characterised by disturbance in language, perception, and social skills that affects an estimated 1-2 per 1,000 people worldwide (although the number is as high as 20 per 1000 in the US). While studies have suggested a disturbance in neural metabolism in patients with ADS, the exact cause of the ASD still remains unknown. In 2013, a single indication of ASD, which united several related conditions (ie, classical autism, Asperger's syndrome, Fragile X Syndrome, Landau-Kleffner Syndrome, Rett syndrome, childhood disintegrative disorder, and PDD-NOS), was included in the fifth edition of the Diagnostic and Statistical Manual of Mood Disorders for the first time in order to support more standardized diagnoses.
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.
The first authoritative textbook specifically addressing issues of the field, this book delivers a focused discussion on several themes in psychiatry while providing a sound background on pharmacovigilance. Internationally-recognised researchers, clinicians and pharmacovigilance experts contributed to this textbook, giving it the benefit of different perspectives and years of experience. Pharmacovigilance in psychiatry provides a thorough introduction to this field but goes on to explore advanced themes such as methodologies and resources used for pharmacovigilance in psychiatry, challenges as well as most recent developments to this field, making it suitable for under-graduates, graduate and post-doctoral students and persons working pharmacovigilance who seek to broaden their knowledge on this subject.
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 provides an overview of the key developments in both acute lymphocytic leukemia and acute myeloid leukemia with a comprehensive guide to the epidemiology, pathogenesis, etiology, clinical manifestations, classification, diagnosis, and staging as well as the most recent developments in the therapeutic landscape for acute leukemia. The Handbook of Acute Leukemia offers readers a key resource into the future outlook for patients with leukemia and is edited and authored by internationally renowned experts in the field. Leukemia is cancer of the white blood cells and acute leukemia means the condition progresses rapidly and aggressively, requiring immediate treatment. Acute leukemia is classified according to the type of white blood cells that are affected: either lymphocytes and myeloid cells.
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 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 proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox.Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area.The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally.
A description of our current understanding of antiepileptic drug use during pregnancy, this book includes chapters on the impact of seizures on the mother and developing child, changes in maternal physiology during pregnancy and its impact on drug disposition, and the pharmacokinetic differences between the various anti-seizure medications. It also deals with the possible harmful effects of antiepileptic drug exposure during pregnancy on the physical and intellectual development of the fetus. Clinicians have to balance the potential adverse effects of the medicine for the fetus and mother-to-be against the risks that uncontrolled seizures hold for both when treating pregnant women with antiepileptic drugs. Only recently have enough scientific data emerged to provide a rational basis for treatment decisions that take in both aspects. This work provides a single, accessible and up-to-date resource for busy clinicians.
In addition to acting as a training guide for pharmacists, pharmacy residents and pharmacy students who seek to practice in areas associated with patients on anticoagulant therapy, the information presented within highlights the growing role of the pharmacist in these contexts. Readers will find useful information on anticoagulant management across all pharmacy practice areas, including the inpatient, ambulatory, emergency services and transitions of care settings. Particular attention is given to summarizing best practices and providing `real world' examples of ways in which pharmacists can be involved in anticoagulation management and the impact of such involvement. In the first major section of the book, each chapter focuses on the role of the pharmacist in the management of medication with a specific type of anticoagulants (e.g. warfarin, heparin and target-specific oral agents) in various healthcare settings. A broader overview of the clinical management of anticoagulation therapy is provided in the second major section, including descriptions of the role of pharmacists in assessing venous thromboembolism risk, ensuring patients receive appropriate prophylactic therapy, and monitoring outcomes.
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.
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.
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.