Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... -international regulation and deregulation -venture capitalist investment -the IND process -informed consent -changes in manufacturing and updated and extended coverage of... -pediatric drug trial design -the advantages and disadvantages of orphan drug designations -the maximization of package inserts for marketing -post approval safety surveillance -withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

Colorectal cancer (CRC) is a major global health challenge as the third leading cause for cancer related mortalities worldwide. Despite advances in therapeutic strategies, the five-year survival rate for CRC patients has remained the same over time due to the fact that patients are often diagnosed in advanced metastatic stages. Drug resistance is another common reason for poor prognosis. Researchers are now developing advanced therapeutic strategies such as immunotherapy, targeted therapy, and combination nanotechnology for drug delivery. In addition, the identification of new biomarkers will potentiate early stage diagnosis.This book is the third of three volumes on recent developments in colorectal diagnosis and therapy. Each volume can be read on its own, or together. Each volume focuses on different novel therapeutic advances, biomarkers, and identifies therapeutic targets for treatment. Written by leading international experts in the field, coverage addresses the role of diet habits and lifestyle in reducing gastrointestinal disorders and incidence of CRC. Chapters discuss current and future diagnostic and therapeutic options for colorectal cancer patients, focusing on immunotherapeutics, nanomedicine, biomarkers, and dietary factors for the effective management of colon cancer.

Cell biology is a rapidly advancing subject. Understanding principles of nuclear architecture is a key question. Researchers are starting to develop more strict and rigorous methods of image processing and quantitative analysis to provide an end-to-end process supporting the fundamental biology.

This book has chapters contributed by experts in the field that address the whole endeavour of teasing out the principles of nuclear architecture: ranging from fundamental science, through imaging processing and quantitative analysis, to applications, related to disease. This material is focussed on the latest breakthroughs, and moreover will emphasise a strict and rigorous development of the scientific process. A systems view is stressed where relevant. The objective is not to provide an encyclopaedic compendium of nuclear architecture information, but rather to present state of the art tools in specific contexts, which will readily generalise.

"This uniformly fine book extends and intensifies the dialogue about grounded theory and nursing.... well-designed, well-crafted, and accessible."
--Sally A. Hutchinson, PhD, RN, FAAN

..".the torch has been passed to a new generation of grounded theorists.... The editors have assembled chapters by many of the best-known scholars in North America."
--Sandra P. Thomas, PhD, RN, FAAN

What is grounded theory? How is it done? When is it most appropriate to use? Grounded theory can be the research method of choice for nurses seeking to find out how people cope with existing or potential health challenges. This book offers broad coverage of method, background, philosophical roots, and new directions for grounded theory in nursing.

Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.

New Developments in Dementia Prevention Research addresses a dearth of knowledge about dementia prevention and shows the importance of considering the broader social impact of certain risk factors, including the role we each play in our own cognitive health throughout the lifespan. The book draws on primary and secondary research in order to investigate the relationship between modifiable factors, including vascular and psychosocial risks, that may affect the incidence of dementia. Bringing together world-leading expertise from applied science, medicine, psychology, health promotion, epidemiology, health economics, social policy and primary care, the book compares and contrasts scientific and service developments across a range of settings. Each chapter presents these themes in a way that will ensure best practice and further research in the field of dementia prevention is disseminated successfully throughout the world. Perhaps most importantly, chapters also question what type of social responsibility we are prepared to embrace in order to address the challenges inherent in dementia prevalence. New Developments in Dementia Prevention Research includes contributions from leading authorities in brain health and dementia prevention and provides an essential contribution to the discourse on dementia prevention. It will be of great interest to academics, researchers and postgraduate students engaged in the study of the psychological and social aspects of aging and dementia.

A major objective of this book is to reveal unprecedented opportunities to understand and overcome drug resistance through the clinical assessment of rational therapeutic drug combinations and the use of predictive and prognostic biomarkers to enable patient stratification and tailor treatments. It offers to the readers an updated overview on the possible reasons of failure of new and promising therapeutic opportunities.

Undue Risk is an unprecedented and chilling history of the use of human subjects in atomic, biological and chemical warfare experiments by the US Government from World War II to the present. Jonathan Moreno, a senior researcher on the President's special commission, goes where few researchers have gone before, exploring secret government documents which reveal a plethora of government experiments.
Now available in paperback, with a new afterword, this exciting read covers recent objections by US military personnel to required anthrax vaccinations and new developments in government policies on experiments involving vulnerable human subjects.

Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:

Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines

Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures

Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers

This book is a useful resource to scientists and researchers in bothindustry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development."

Theory of Drug Development presents a formal quantitative framework for understanding drug development that goes beyond simply describing the properties of the statistics in individual studies. It examines the drug development process from the perspectives of drug companies and regulatory agencies. By quantifying various ideas underlying drug development, the book shows how to systematically address problems, such as: Sizing a phase 2 trial and choosing the range of p-values that will trigger a follow-up phase 3 trial Deciding whether a drug should receive marketing approval based on its phase 2/3 development program and recent experience with other drugs in the same clinical area Determining the impact of adaptive designs on the quality of drugs that receive marketing approval Designing a phase 3 pivotal study that permits the data-driven adjustment of the treatment effect estimate Knowing when enough information has been gathered to show that a drug improves the survival time for the whole patient population Drawing on his extensive work as a statistician in the pharmaceutical industry, the author focuses on the efficient development of drugs and the quantification of evidence in drug development. He provides a rationale for underpowered phase 2 trials based on the notion of efficiency, which leads to the identification of an admissible family of phase 2 designs. He also develops a framework for evaluating the strength of evidence generated by clinical trials. This approach is based on the ratio of power to type 1 error and transcends typical Bayesian and frequentist statistical analyses.

This book is a simple guide to the diagnosis, investigation, and treatment of all gynaecological cancers. It discusses the management of patients with gynaecological malignancies; considers the principles of chemotherapy, radiotherapy, and surgery; explains when and why each modality is used in treatment; covers the pathology of gynaecological cancer; discusses treatment of the advanced disease; and includes a chapter on the role of palliative care. The multidisciplinary approach reflects the cooperative practice in combined clinics.

This inspirational text will appeal to those both starting research projects and those wanting to understand how research can be used in everyday working practice. It brings together expertise from a wide range of areas and makes research easy and accessible. The practical workbook style is easy to use and shows the whole process from design to dissemination and application. Those working in primary healthcare teams and the new organisations supporting them will find it essential reading. Primary Care Research series is aimed at developing the knowledge, expertise and skills of all practitioners in primary care. Each book is based on contributions from experts in their field and is supported by practical facts, personal insight, support and advice. They enable all primary care practitioners to realise the potential of exploring information used in everyday working practice. Other books in the Primary Care Research series: Wilson: Research Approaches in Primary Care Mathers: Statistical Analysis in Primary Care

This book focuses on analytical similarity assessment in biosimilar product development following the FDA's recommended stepwise approach for obtaining totality-of-the-evidence for approval of biosimilar products. It covers concepts such as the tiered approach for assessment of similarity of critical quality attributes in the manufacturing process of biosimilar products, models/methods like the statistical model for classification of critical quality attributes, equivalence tests for critical quality attributes in Tier 1 and the corresponding sample size requirements, current issues, and recent developments in analytical similarity assessment.

A vast number of diagnostic and therapeutic decisions are based on measuring blood concentrations of molecules, yet most biochemical and pharmacological events actually take place in the tissues. Microdialysis is a key semi-invasive sampling technique to measure in vivo drug penetration to the target site in humans, the method being feasible in virtually every organ. Authored by international experts in this cutting edge field, this book will provide a comprehensive overview of microdialysis and its application for measuring drug distribution in drug development.

In this Information Age, the practices of clinical medicine should no longer be based on what clinical doctors actively know. Rather, all of the importantly practice-relevant knowledge should not only already exist but also be codified in cyberspace, in directly practice-guiding 'expert systems' -- for the benefit of both doctors and patients everywhere. Each of these systems (discipline-specific) would, prompted by a particular type of case presentation, present the doctor a questionnaire specific to cases of the type at issue, and document the doctor's answers to the questions. If at issue would be a case of complaint about a (particular type of) sickness, the system would translate the resulting diagnostic profile of the case into the corresponding probabilities of the illnesses to be considered. Similarly, if at issue would be an already-diagnosed case of a particular illness, the system would ask about, and record, the relevant elements in the prognostic profile of the case and then translate this profile into the probabilities of various outcomes to be considered, probabilities specific to the choice of treatment and prospective time in addition to that profile. And besides, these systems would analogously address the causal origin -- etiogenesis -- of cases of particular types of illness. While the requisite knowledge-base for these systems -- notably for the probabilities in them -- has not been addressed by such 'patient-oriented' clinical research as has been conducted (very extensively) up to now, this book delineates the nature of the suitably-transformed research (gnostic). The critically-transformative innovation in the research is the studies' focus on Gnostic Probability Functions -- dia-, etio-, and prognostic -- in the framework of logistic regression models. This book also presents a vision of how this critically-transformative research would most expeditiously be provided for and also conducted, among select sets of academic teaching hospitals.

This concise guide covers the important angles of your grant application, whether for a health research project or personal training programme, and will help you be among the successful applicants.

The author, a reviewer for grant funding organisations and internationally respected research scientist, gives you the benefit of his experience from both sides of the process in this easy-to-use, readable guide. The book takes you through the grant application process, explaining how to: Present the justification for the proposed projectDescribe the study design clearlyEstimate the financial costsUnderstand a typical review process, and how this can influence the contents of the grant application

The author provides practical advice on a range of project types (observational studies, clinical trials, laboratory experiments, and systematic reviews) to increase the chance that your application will be successful. There are also tips on what to avoid throughout the application.

With generic information about application requirements, "How to Write a Grant Application" is ideal for healthcare professionals seeking a health services or scientific grant.

This book presents a unique approach not found in any other text for those looking to improve the clinical results of refractive surgery by gaining a better understanding of corneal biomechanics and the instrumentation related to it. Written by leading experts in the field, this book provides authoritative coverage of the interactions of the cornea and the bioinstrumentation, such as corneal topography, pachymetry, aberrometers, tonometry and optical coherence tomography. Organized in an easy-to-read manner, Corneal Biomechanics and Refractive Surgery is designed for refractive surgeons and general ophthalmologists alike and describes the biomechanical role of the corneal tissue and how each part is affected in refractive surgery. Additionally, showing what the bioinstrumentation can measure, how models can improve understanding of the interaction between biomechanics, bioinstrumentation, and refractive surgery, and how these models and bioinstrumentation together can improve the refractive results, are also discussed.

An understanding of each of the critical components of the funding process is key to meeting the challenges posed by the increasingly intense competition for research funds. This book is a vital tool for those who want to build and maximize their grant support. Although many publications provide valuable information about proposal preparation, few cover the full spectrum of issues--from planning through execution--in the funding process. The book leads off with a discussion of the relationship between researchers and the funding environment, features of good short- and long-range funding plans, characteristics of funding organizations in terms of funding power, mission, and priorities, and the manner in which funding information is disseminated. Succeeding chapters focus on the actual development of the many different types of opportunities--research projects, multicomponent research programs, career development and training programs, and small business innovation research. These chapters emphasize conceptualizing an idea, optimizing the researcher-sponsor match, and testing the concept for competitiveness. Further chapters deliver strategies for translating research ideas into written proposals, preparing administrative sections and communicating with a sponsor. The final chapters are dedicated to the outcomes of the proposal process: reviews, rebuttals, and resubmissions; and to progress reports and future proposals for maintaining and building on funding. Flowcharts, examples, and summary tables are used throughout the text to highlight key points.

Animal Models in Orthopaedic Research is a reference book of the major animal models used in the study of orthopaedic conditions and in the in vivo study of biomaterials. Use of animal models provides important knowledge about pathological conditions that can eventually lead to the development of more effective clinical treatment of diseases in both humans and animals. Directed primarily toward surgeons, investigators, research fellows, graduate students, and those working in orthopaedic or biomaterial research, this book is intended to serve as a basis for a literature search before embarking on a detailed research project.
This book is the result of the editors' own quest for information about research methodology and the use of animal models in orthopaedic and biomaterial research. Concise, inclusive, and practical, this work:

Provides the only single-volume reference for stability requirement in all major markets Discusses all aspects of stability testing, including ICH stability guidelines Supports the text with real-world examples In this book, recognized industry experts and regulatory inspectors from the world's pharmaceutical manufacturing regions provide stability requirements in all the major markets and discuss all aspects of stability testing and biotechnology. Participants in the ICH debates interpret the ICH guidelines. Other discussions focus on European requirements, the ICH initiatives, the US SUPAC initiative, matrixing and bracketing approaches from the cGMP and FDA perspective, and stability requirements in Japan, Australia, and WHO. Stress programs, testing of preservatives, and physical stability topics are addressed as well as various protocols and statistical approaches.

For the convenience of research workers, particularly those with limited knowledge of embryology, we have put together a series of tables to enable rapid identification of specific stages of embryonic development in the more commonly used mammals. Because if its frequent usage the chick embryo is included this atlas.

This volume's purpose is to describe concepts and methods concerning assessment of health-related quality of life (HRQOL) in children and adolescents with a special focus on chronic health conditions. The impetus for this book came from a recognition of the increasing importance of HRQOL assessments in the evaluation of treatment outcomes and the need to increase the utilization of HRQOL assessments in research and clinical applications with a range of pediatric populations. The need to develop a volume that describes new research and clinical applications concerning this topic stemmed from several recent developments. There is a continuing need for evaluations of the efficacy of medical treatments for children and adolescents, including those with chronic health conditions.
To address these critical unmet needs in the field of HRQOL assessment, and to advance scientific methods and clinical applications in this field, a conference was held at Case Western Reserve University. The conference set out to summarize current information concerning the development and implementation of measures of HRQOL assessment, to identify and consider key conceptual and methodological issues in research concerning the measurement of HRQOL, and to recommend priorities to advance the state-of-the-art in research and clinical applications of QOL assessment in children and adolescents with chronic health conditions. This volume summarizes and synthesizes the information that was presented by the conference participants in a series of lively discussions and chapters that were based on the presentations.

This volume's purpose is to describe concepts and methods concerning assessment of health-related quality of life (HRQOL) in children and adolescents with a special focus on chronic health conditions. The impetus for this book came from a recognition of the increasing importance of HRQOL assessments in the evaluation of treatment outcomes and the need to increase the utilization of HRQOL assessments in research and clinical applications with a range of pediatric populations. The need to develop a volume that describes new research and clinical applications concerning this topic stemmed from several recent developments. There is a continuing need for evaluations of the efficacy of medical treatments for children and adolescents, including those with chronic health conditions.
To address these critical unmet needs in the field of HRQOL assessment, and to advance scientific methods and clinical applications in this field, a conference was held at Case Western Reserve University. The conference set out to summarize current information concerning the development and implementation of measures of HRQOL assessment, to identify and consider key conceptual and methodological issues in research concerning the measurement of HRQOL, and to recommend priorities to advance the state-of-the-art in research and clinical applications of QOL assessment in children and adolescents with chronic health conditions. This volume summarizes and synthesizes the information that was presented by the conference participants in a series of lively discussions and chapters that were based on the presentations.