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.

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.

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 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.

The great hurry to realise promised cures in stem cell research requires regulation to guarantee bioethical research practices. Yet, increasingly similar national guidelines for stem cell research yields a range of diverging research practices. This book shows how the different rationale of regulation affects stem cell research practices in Asia. In low- and medium income countries such as India and China the advancement of science has a different weight on the national agenda, and the evaluation of scientific research is measured with a different yardstick, depending on the political and national research environment. For developing countries the question of research funding into stem cell research, healthcare, and the donation of embryos, foetuses and oocytes entail different considerations compared to in affluent welfare societies. Moreover, research institutions have different cultural and political histories, so that the meaning of formal guidelines, legislation and social rules may differ according to their various institutional settings. This volume discusses the informal cultures, social conventions and traditions that are crucial to the way in which stem cell research takes place in Asia. This book was originally published as a special issue of New Genetics and Society.

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:

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.

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.

The aim of this book is to suggest and exemplify a systematic methodology for analysing survival data which contains "immune," or "cured" individuals, denoted generically as "long-term survivors." Such data occurs in medical and epidemiological applications, where the intention may be to identify whether or not cured or immune individuals are present in a population, perhaps as a result of treatments given; in the analysis of recidivism data in criminology, where the intentions are similar with respect to prisoners released from and possibly returning to prison; and in many other areas where followup data is available on individuals, with the possibility that not all suffer the event under investigation. Both nonparametric and parametric methods are proposed and developed. The effects of covariate information can be assessed via a kind of generalised linear framework in the parametric analyses. The proposed methodologies are supported by asymptotic analyses and simulations of real situations. While these theoretical underpinnings are presented in reasonable rigour and detail, the book is aimed very much at the practitioner who wishes to analyse survival data with (or even without) immunes.

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.

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.

Biomaterials are used in many areas of medicine, particularly in surgery and d- tistry. In orthopedic surgery, total hip arthroplasty has been extremely successful, and has been called 'the operation of the 20th century'. Total hip arthroplasty is r- tinely performed every day in most orthopedic departments. Over the last decades, many efforts have been made to better integrate the components within the recipient bones, to decrease the friction at the prosthetic interface, and to minimize wear. Minimally invasive procedures have been developed, and various designs are inte- ed to preserve as much as possible of the bone stock of young patients. By contrast, the clinical results have been less favorable after various hand and wrist joint replacements. Many early designs have failed, the clinical data of the current pr- theses are frequently quite limited, and there is often insufficient biomechanical information available, although trapezio-metacarpal arthroplasty in particular has become quite popular in recent years. In order to promote progress in hand and wrist arthroplasty, Antonio Merolli and Thomas J. Joyce have edited this lovely book, whose chapters discuss current research and recent advances in hand and wrist arthroplasty. The problems of metacarpophalangeal joint prostheses are particularly developed.

Acres of Skin sheds light on a dark episode in American medical history. From the mid-1950s to the mid-1970s, inmates at Philadelphia's Holmesburg Prison were used, in exchange for a few dollars, as guinea pigs in a host of medical experiments. Drawing on in-depth interviews with dozens of prisoners as well as the doctors and prison officials who, respectively, performed and enforced these tests, Allen M. Hornblum paints a harrowing portrait of medical abuse, moral indifference, and stark greed.
Acres of Skin raises provocative questions about human rights, prison treatment, and medical and research ethics as he exposes what really happened behind the locked doors of this American prison. The book answers the question: were there other prisons like this?

Praise for the Second Edition: "... this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics "This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered ..." - Journal of the Royal Statistical Society Sample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation. Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women's health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.

This volume describes important medical discoveries, from the introduction of the first antibiotic to the present, where serendipity, intuition, coincidence, or laboratory accident played an important role in bringing a discovery to light. Although chance is the principal determinant, the book emphasizes other factors, such as economic and political exigencies and being in the right place at the right time.

This volume collates articles investigating antioxidant, oxidant and free radical research. It examines the role of such research in health and disease, particulary with respect to developing greater understanding about the many interactions between oxidants and antioxidants, and how such substances may act as natural protectants and /or natural toxicants.

Chemoprevention of Esophageal Squamous Cell Carcinoma with Berries, by Gary D. Stoner and Li-Shu Wang

Cancer Prevention by Different Forms of Tocopherols, by Chung S. Yang and Nanjoo Suh

Cancer Chemopreventive and Therapeutic Potential of Guggulsterone, by Inas Almazari and Young-Joon Surh

Inhibition of UVB-Induced Nonmelanoma Skin Cancer: A Path from Tea to Caffeine to Exercise to Decreased Tissue Fat, by Allan H. Conney, You-Rong Lou, Paul Nghiem, Jamie J. Bernard, George C. Wagner and Yao-Ping Lu

Cancer Chemoprevention and Nutri-Epigenetics: State of the Art and Future Challenges, by Clarissa Gerhauser

A Perspective on Dietary Phytochemicals and Cancer Chemoprevention: Oxidative Stress, Nrf2, and Epigenomics, by Zheng-Yuan Su, Limin Shu, Tin Oo Khor, Jong Hun Lee, Francisco Fuentes and Ah-Ng Tony Kong

Keap1-Nrf2 Signaling: A Target for Cancer Prevention by Sulforaphane, by Thomas W. Kensler, Patricia A. Egner, Abena S. Agyeman, Kala Visvanathan, John D. Groopman, Jian-Guo Chen, Tao-Yang Chen, Jed W. Fahey and Paul Talalay

Chemoprotection Against Cancer by Isothiocyanates: A Focus on the Animal Models and the Protective Mechanisms, by Albena T. Dinkova-Kostova

Human Cancer Chemoprevention: Hurdles and Challenges, by Vaqar Mustafa Adhami and Hasan Mukhtar

Personalizing Lung Cancer Prevention Through a Reverse Migration Strategy, by Kathryn A. Gold, Edward S. Kim, Ignacio I. Wistuba and Waun K. Hong

Natural-Agent Mechanisms and Early-Phase Clinical Development, by Janet L. Wang, Kathryn A. Gold and Scott M. Lippman

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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 superb account of the development of scientific research in the state of Baden places the growth of big science in 19th century Germany within a broad social and economic context. The book analyses the growth of scientific research and its institutionalization in the state university system. With the focus on the experimental sciences, the book explores the introduction of the research ethic into the university medical curriculum, and the process by which laboratory science came to be an essential pedagogical tool in the education of the future citizens of the state. The social and economic changes that ultimately transformed Germany into a modern industrial state are considered. It was within this setting that laboratory training, once considered inappropriate for university studies, slowly increased in status, and dissatisfaction with the overly theoretical education traditionally offered by the universities began to grow. Thus, much like computers today, the scientific method in the nineteenth century came to represent an instrument for teaching not only specific skills but also a particular way of approaching, analysing, and solving the problems of an industrializing economy. This compelling volume will be of interest to historians of science, medicine, and European studies.

This volume discusses the latest technologies used to study all aspects of Fragile-X Syndrome (FXS). The chapters in this book cover topics such as monitoring for epigenetic modifications at the FMR1 locus; modeling FXS with human pluripotent stem cells, mouse neural progenitors; mouse versus human-based models for FXS pre-clinical research; and Fragile-X associated with Tremor/Ataxia Syndrome (FXTAS). Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Cutting-edge and thorough, Fragile-X Syndrome: Methods and Protocols is a valuable tool to help scientists working towards one day developing a therapeutic solution to improve the symptoms of FXS. Chapter "Induced Neurons for the Study of Neurodegenerative and Neurodevelopmental Disorders" is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

This unique reference provides concise, single-source coverage of the clinical, research, and therapeutic aspects of dermatological problems associated with bacteria, fungi, and viruses.
Introduces many novel antifungal, antibacterial, and antiviral agents
Highlighting the molecular biology as well as risk - benefit ratios of new diagnostic and treatment modalities, Cutaneous Infection and Therapy
evaluates the role of antimicrobial soaps in personal hygiene and research on preoperative skin preparation and infection rates
discusses reasons for the reduced risk of infection using occlusive wound dressings
explains the epidemiology, presentation, pathophysiology, and treatment of athlete's foot and fungal diseases of the scalp
presents new oral antifungals for the treatment of onychomycosis
examines the advantages and disadvantages of preparations to treat superficial fungal infections
addresses oral candidiasis in HIV infection and the resistance to antifungal therapy in AIDS patients
reviews the patterns of candidiasis in children and current approaches to antifungal therapy
covers the epidemiology, implications, and management of herpes in pregnant women and newborns
and much more

Animal experimentation is one of the most controversial areas of debate on animal rights. Biomedical research is at the hard edge of these debates: it throws up fundamental questions of moral value - of whether human life is more important than that of animals. Much experimentation is defended by its apparent success in terms of increasing medical knowledge. This study investigates whether biomedical research using animals is, in fact, scientifically justified. The authors show that in scientific terms - using the models that scientists themselves use - these claims are exaggerated, or even false. They argue that we need to reassess our use of animals and, indeed, rethink the standard positions in the debate. Their analysis reveals why research using animals might be a source of hypotheses about human biomedical phenomena, yet would never prove or establish anything about this phenomena.

This book is being planned as a tribute to Dr. Victor A. McKusick (1921-2008), who is well known as the "father of medical genetics". He was long associated with the Johns Hopkins University School of Medicine, first as a student in the 1940s, and later as a faculty member, becoming the Chairman of the Department of Medicine at Johns Hopkins. He was a co-founder of GENOMICS and founder and lifelong editor of Mendelian Inheritance in Man, a massive compendium of human syndromes and genetic variants. Dr. McKusick made distinguished contributions to all branches of medical genetics. He was a member of the U.S. National Academy of Sciences and many other academies in the world. He was awarded the National Medal of Science in 2002. He received many other honors including several honorary doctorates. The proposed book will reflect all the fields touched upon by Dr. McKusick's contributions. It will be a valuable source of the latest progress in medical genetics. The contributors are internationally distinguished in their chosen specialties. Besides professional distinction, they are being selected because of their past association with Dr. McKusick, as former students or colleagues who extended his research in some fashion. The proposed book will reflect all the fields touched upon by Dr. McKusick's contributions. It will be a valuable source of the latest progress in medical genetics. The contributors are internationally distinguished in their chosen specialties. Besides professional distinction, they are being selected because of their past association with Dr. McKusick, as former students or colleagues who extended his research in some fashion.