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Targeted Therapy in Translational Cancer Research

Targeted Therapy in Translational Cancer Research
  • Author : Apostolia-Maria Tsimberidou,Razelle Kurzrock,Kenneth C. Anderson
  • Publisher :Unknown
  • Release Date :2015-10-08
  • Total pages :320
  • ISBN : 9781118468685
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Summary : Targeted Therapy in Translational Cancer Research for the Translational Oncology series provides a comprehensive overview of recent developments in our understanding of tumor biology, elucidates the roles of targets and pathways involved in carcinogenesis, and describes current state-of-the-art anticancer therapy, as well as the most promising areas of translational research and targeted therapy. Introduces cutting-edge ‘bench to bedside and back’ breakthroughs which have transformed the diagnosis, prognosis, and treatment of cancer Covers basic principles of targeted therapy, including immunotherapy and the roles of cancer stem cells, the microenvironment, angiogenesis, epigenetics, microRNAs, and functional imaging in precision medicine Summarises major advances in therapeutic management of hematologic malignancies and solid tumors using conventional therapy, targeted therapy, immunotherapy, or novel treatment modalities

Pharmaceutical Toxicology in Practice

Pharmaceutical Toxicology in Practice
  • Author : Alberto Lodola,Jeanne Stadler
  • Publisher :Unknown
  • Release Date :2011-03-31
  • Total pages :280
  • ISBN : 9780470922729
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Summary : This book describes, with references to key source materials, the background to, and conduct of, the principal nonclinical studies that are central to drug development. The chapters provide an understanding of the key components of the preclinical phase of drug development with a hands-on description, with core chapters addressing study conduct, types, and reporting. As such, it is a practical guide through toxicology testing and an up-to-date reference on current issues, new developments, and future directions in toxicology. Opening with a practical description of toxicology and its role in the development of pharmaceuticals, the book proceeds to detail international regulations (including the impact of the new REACH standards for chemical safety), interdisciplinary interactions among scientists in drug development, steps in toxicity testing, and risk management. Further, the book covers the methods of genetic toxicology (assays, genomics, in vivo screening) as a complement to “traditional” toxicology in the risk assessment and risk management of pharmaceuticals.

Handbook

Handbook
  • Author : World Health Organization
  • Publisher :Unknown
  • Release Date :2010-02-02
  • Total pages :309
  • ISBN : 9789241547550
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Summary : A new edition of one of Zola's lesser-known novels from the Rougon-Macquart Cycle Finding the young Angélique on their doorstep one Christmas Eve, the pious Hubert couple decide to bring her up as their own. As the girl grows up in the vicinity of the town's towering cathedral and learns her parents' trade of embroidery, she becomes increasingly fascinated by the lives of the saints, a passion fueled by her reading of the Golden Legend and other mystical Christian writings. One day love, in the shape of Félicien Hautecoeur, enters the dream world she has constructed around herself, bringing about upheaval and distress. Although it provides a detailed portrait of provincial 19th-century life and it adheres to a naturalist approach, The Dream eschews many of the characteristics of Zola's other novels of the Rougon-Macquart cycle—such as a pronounced polemical agenda or a gritty subject matter—offering instead a timeless, lyrical tale of love and innocence.

Global Approach in Safety Testing

Global Approach in Safety Testing
  • Author : Jan Willem van der Laan,Joseph J DeGeorge
  • Publisher :Unknown
  • Release Date :2013-02-11
  • Total pages :315
  • ISBN : 9781461459507
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Summary : This volume will consider one of ICH’s major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the “lessons learnt” and “future developments”.

Handbook of Bioequivalence Testing

Handbook of Bioequivalence Testing
  • Author : Sarfaraz K. Niazi
  • Publisher :Unknown
  • Release Date :2014-10-29
  • Total pages :1007
  • ISBN : 9781482226386
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Summary : As the generic pharmaceutical industry continues to grow and thrive, so does the need to conduct adequate, efficient bioequivalence studies. In recent years, there have been significant changes to the statistical models for evaluating bioequivalence. In addition, advances in the analytical technology used to detect drug and metabolite levels have m

Ethical Conduct of Clinical Research Involving Children

Ethical Conduct of Clinical Research Involving Children
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Clinical Research Involving Children
  • Publisher :Unknown
  • Release Date :2004-07-09
  • Total pages :445
  • ISBN : 0309133386
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Summary : In recent decades, advances in biomedical research have helped save or lengthen the lives of children around the world. With improved therapies, child and adolescent mortality rates have decreased significantly in the last half century. Despite these advances, pediatricians and others argue that children have not shared equally with adults in biomedical advances. Even though we want children to benefit from the dramatic and accelerating rate of progress in medical care that has been fueled by scientific research, we do not want to place children at risk of being harmed by participating in clinical studies. Ethical Conduct of Clinical Research Involving Children considers the necessities and challenges of this type of research and reviews the ethical and legal standards for conducting it. It also considers problems with the interpretation and application of these standards and conduct, concluding that while children should not be excluded from potentially beneficial clinical studies, some research that is ethically permissible for adults is not acceptable for children, who usually do not have the legal capacity or maturity to make informed decisions about research participation. The book looks at the need for appropriate pediatric expertise at all stages of the design, review, and conduct of a research project to effectively implement policies to protect children. It argues persuasively that a robust system for protecting human research participants in general is a necessary foundation for protecting child research participants in particular.

Small Clinical Trials

Small Clinical Trials
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
  • Publisher :Unknown
  • Release Date :2001-01-01
  • Total pages :222
  • ISBN : 0309171148
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Summary : Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

Developmental and Reproductive Toxicology

Developmental and Reproductive Toxicology
  • Author : Ronald D. Hood,Ronald D Hood
  • Publisher :Unknown
  • Release Date :2005-08-30
  • Total pages :1168
  • ISBN : 9781420040548
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Summary : Completely revised and updated, Developmental and Reproductive Toxicology: A Practical Approach, Second Edition draws together valuable information typically scattered throughout the literature, plus some not previously published, into one complete resource. In addition to the traditional aspects of developmental toxicity testing, the book covers evaluating and interpreting data. Originally titled Handbook of Developmental Toxicology, the second edition's new name reflects significant changes in its content and scope. New coverage in the Second Edition: Genomics and proteomics Tests for endocrine disruptors Testing for male and female reproductive toxicity Extensive treatment of the significance, reliability, and interpretation of developmental and reproductive toxicity data Toxicity testing in neonatal and juvenile animals Postnatal developmental milestones FDA perspective on risk assessment Extensive glossaries of developmental defect terminology Previous books on this subject have largely been academically oriented and not intended to guide the practicing developmental or reproductive toxicologist. Useful and informative, this book blends the theoretical foundation with insights gained from hands-on experience. It includes tables of comparative developmental milestones - both pre- and postnatal, glossaries of descriptive terms used in developmental toxicity evaluation, and both US and international regulatory guidelines. Bridging the gap between theory and application, this is a handy single-source of essential information to use in planning, conducting, and interpreting studies.

Integrating Clinical Research into Epidemic Response

Integrating Clinical Research into Epidemic Response
  • Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Board on Global Health,Committee on Clinical Trials During the 2014-2015 Ebola Outbreak
  • Publisher :Unknown
  • Release Date :2017-07-26
  • Total pages :342
  • ISBN : 9780309457767
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Summary : The 2014â€"2015 Ebola epidemic in western Africa was the longest and most deadly Ebola epidemic in history, resulting in 28,616 cases and 11,310 deaths in Guinea, Liberia, and Sierra Leone. The Ebola virus has been known since 1976, when two separate outbreaks were identified in the Democratic Republic of Congo (then Zaire) and South Sudan (then Sudan). However, because all Ebola outbreaks prior to that in West Africa in 2014â€"2015 were relatively isolated and of short duration, little was known about how to best manage patients to improve survival, and there were no approved therapeutics or vaccines. When the World Heath Organization declared the 2014-2015 epidemic a public health emergency of international concern in August 2014, several teams began conducting formal clinical trials in the Ebola affected countries during the outbreak. Integrating Clinical Research into Epidemic Response: The Ebola Experience assesses the value of the clinical trials held during the 2014â€"2015 epidemic and makes recommendations about how the conduct of trials could be improved in the context of a future international emerging or re-emerging infectious disease events.

The Role of the Study Director in Nonclinical Studies

The Role of the Study Director in Nonclinical Studies
  • Author : William J. Brock,Barbara Mounho,Lijie Fu
  • Publisher :Unknown
  • Release Date :2014-06-03
  • Total pages :545
  • ISBN : 9781118370391
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Summary : A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry

Fundamentals of Biologicals Regulation

Fundamentals of Biologicals Regulation
  • Author : Rebecca Sheets
  • Publisher :Unknown
  • Release Date :2017-12-13
  • Total pages :450
  • ISBN : 9780128094433
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Summary : Fundamentals of Biologicals Regulation: Vaccines and Biotechnology Medicines serves as an introduction to the international regulatory arena in which biologicals are developed and offers an overview of the processes and insight into the scientific concepts underpinning global regulations. This book will provide multiple levels of readership with guidance on basic concepts, a detailed look at regulatory challenges, and practical insight into how regulators consider regulatory science and regulatory process issues across various regions. With numerous case studies, learning activities, and real-world examples across several classes of biotechnological products, this book is a valuable and comprehensive resource for graduate students, professors, regulatory officials, and industry scientists working with biologicals. Provides a broad overview and introduction to the regulatory processes, from product development pathways, through clinical trials and product development stages and beyond Includes FDA, EMA, ICH, and WHO recommendations and guidelines so readers can compare and contrast the different regulatory regions with their expectations and understand why they are different Contains chapters on some of the exceptions to the process including how biosimilars and in vitro diagnostics are regulated Includes numerous case studies, learning activities, and real-world examples across several classes of biotechnological products

OECD Guidelines for Testing of Chemicals

OECD Guidelines for Testing of Chemicals
  • Author : Organisation for Economic Co-operation and Development
  • Publisher :Unknown
  • Release Date :1981
  • Total pages :229
  • ISBN : 9264122214
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Summary :

A Comprehensive Guide to Toxicology in Preclinical Drug Development

A Comprehensive Guide to Toxicology in Preclinical Drug Development
  • Author : Ali S. Faqi
  • Publisher :Unknown
  • Release Date :2012-11-16
  • Total pages :885
  • ISBN : 9780123878151
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Summary : A Comprehensive Guide to Toxicology in Preclinical Drug Development is a resource for toxicologists in industry and regulatory settings, as well as directors working in contract resource organizations, who need a thorough understanding of the drug development process. Incorporating real-life case studies and examples, the book is a practical guide that outlines day-to-day activities and experiences in preclinical toxicology. This multi-contributed reference provides a detailed picture of the complex and highly interrelated activities of preclinical toxicology in both small molecules and biologics. The book discusses discovery toxicology and the international guidelines for safety evaluation, and presents traditional and nontraditional toxicology models. Chapters cover development of vaccines, oncology drugs, botanic drugs, monoclonal antibodies, and more, as well as study development and personnel, the role of imaging in preclinical evaluation, and supporting materials for IND applications. By incorporating the latest research in this area and featuring practical scenarios, this reference is a complete and actionable guide to all aspects of preclinical drug testing. Chapters written by world-renowned contributors who are experts in their fields Includes the latest research in preclinical drug testing and international guidelines Covers preclinical toxicology in small molecules and biologics in one single source

Psychological Abstracts

Psychological Abstracts
  • Author : American psychological association
  • Publisher :Unknown
  • Release Date :2002
  • Total pages :229
  • ISBN : 00332887
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Summary :

The Role of Clinical Studies for Pets with Naturally Occurring Tumors in Translational Cancer Research

The Role of Clinical Studies for Pets with Naturally Occurring Tumors in Translational Cancer Research
  • Author : National Academies of Sciences, Engineering, and Medicine,Institute of Medicine,Board on Health Care Services,National Cancer Policy Forum
  • Publisher :Unknown
  • Release Date :2016-01-09
  • Total pages :82
  • ISBN : 9780309379908
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Summary : Traditional preclinical mouse models of cancer have been very useful for studying the biology of cancer, however they often lack key characteristics of human cancers. As a result, many novel drug candidates fail in human clinical trials despite evidence of drug efficacy in those preclinical models. Thus, researchers are seeking new approaches to augment preclinical knowledge before undertaking clinical trials for human patients. Recently, there has been renewed interest in comparative oncology - the study of naturally developing cancers in animals as models for human disease - as one way to improve cancer drug development and reduce attrition of investigational agents. Tumors that spontaneously develop in pet dogs and other companion animals as a result of normal aging share many characteristics with human cancers, such as histological appearance, tumor genetics, biological behavior, molecular targets, and therapeutic response. In June 2015 the Institute of Medicine hosted a workshop to examine the rationale and potential for integrating clinical trials for pet patients with naturally occurring cancers into translational cancer research and development. Participants discussed the research needs, strategies, and resources to support greater integration of clinical trials for pets with cancer into translational research pathways, and challenges and potential solutions for facilitating that integration. This report summarizes the presentations and discussions from the workshop.

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries

Nonclinical Statistics for Pharmaceutical and Biotechnology Industries
  • Author : Lanju Zhang
  • Publisher :Unknown
  • Release Date :2016-01-13
  • Total pages :698
  • ISBN : 9783319235585
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Summary : This book serves as a reference text for regulatory, industry and academic statisticians and also a handy manual for entry level Statisticians. Additionally it aims to stimulate academic interest in the field of Nonclinical Statistics and promote this as an important discipline in its own right. This text brings together for the first time in a single volume a comprehensive survey of methods important to the nonclinical science areas within the pharmaceutical and biotechnology industries. Specifically the Discovery and Translational sciences, the Safety/Toxiology sciences, and the Chemistry, Manufacturing and Controls sciences. Drug discovery and development is a long and costly process. Most decisions in the drug development process are made with incomplete information. The data is rife with uncertainties and hence risky by nature. This is therefore the purview of Statistics. As such, this book aims to introduce readers to important statistical thinking and its application in these nonclinical areas. The chapters provide as appropriate, a scientific background to the topic, relevant regulatory guidance, current statistical practice, and further research directions.

Anticancer Drug Development Guide

Anticancer Drug Development Guide
  • Author : Beverly A. Teicher,Paul A. Andrews
  • Publisher :Unknown
  • Release Date :2004-02-01
  • Total pages :451
  • ISBN : 9781592597390
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Summary : This unique volume traces the critically important pathway by which a "molecule" becomes an "anticancer agent. " The recognition following World War I that the administration of toxic chemicals such as nitrogen mustards in a controlled manner could shrink malignant tumor masses for relatively substantial periods of time gave great impetus to the search for molecules that would be lethal to specific cancer cells. Weare still actively engaged in that search today. The question is how to discover these "anticancer" molecules. Anticancer Drug Development Guide: Preclinical Screening, Clinical Trials, and Approval, Second Edition describes the evolution to the present of preclinical screening methods. The National Cancer Institute's high-throughput, in vitro disease-specific screen with 60 or more human tumor cell lines is used to search for molecules with novel mechanisms of action or activity against specific phenotypes. The Human Tumor Colony-Forming Assay (HTCA) uses fresh tumor biopsies as sources of cells that more nearly resemble the human disease. There is no doubt that the greatest successes of traditional chemotherapy have been in the leukemias and lymphomas. Since the earliest widely used in vivo drug screening models were the murine L 1210 and P388 leukemias, the community came to assume that these murine tumor models were appropriate to the discovery of "antileukemia" agents, but that other tumor models would be needed to discover drugs active against solid tumors.

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide

Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide
  • Author : Agency for Health Care Research and Quality (U.S.)
  • Publisher :Unknown
  • Release Date :2013-02-21
  • Total pages :204
  • ISBN : 9781587634239
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Summary : This User’s Guide is a resource for investigators and stakeholders who develop and review observational comparative effectiveness research protocols. It explains how to (1) identify key considerations and best practices for research design; (2) build a protocol based on these standards and best practices; and (3) judge the adequacy and completeness of a protocol. Eleven chapters cover all aspects of research design, including: developing study objectives, defining and refining study questions, addressing the heterogeneity of treatment effect, characterizing exposure, selecting a comparator, defining and measuring outcomes, and identifying optimal data sources. Checklists of guidance and key considerations for protocols are provided at the end of each chapter. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews. More more information, please consult the Agency website: www.effectivehealthcare.ahrq.gov)

WHO Guidelines on Hand Hygiene in Health Care

WHO Guidelines on Hand Hygiene in Health Care
  • Author : World Health Organization
  • Publisher :Unknown
  • Release Date :2009
  • Total pages :262
  • ISBN : 9241597909
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Summary : The WHO Guidelines on Hand Hygiene in Health Care provide health-care workers (HCWs), hospital administrators and health authorities with a thorough review of evidence on hand hygiene in health care and specific recommendations to improve practices and reduce transmission of pathogenic microorganisms to patients and HCWs. The present Guidelines are intended to be implemented in any situation in which health care is delivered either to a patient or to a specific group in a population. Therefore, this concept applies to all settings where health care is permanently or occasionally performed, such as home care by birth attendants. Definitions of health-care settings are proposed in Appendix 1. These Guidelines and the associated WHO Multimodal Hand Hygiene Improvement Strategy and an Implementation Toolkit (http://www.who.int/gpsc/en/) are designed to offer health-care facilities in Member States a conceptual framework and practical tools for the application of recommendations in practice at the bedside. While ensuring consistency with the Guidelines recommendations, individual adaptation according to local regulations, settings, needs, and resources is desirable. This extensive review includes in one document sufficient technical information to support training materials and help plan implementation strategies. The document comprises six parts.

Handbook of Organizational Design: Adapting organizations to their environments

Handbook of Organizational Design: Adapting organizations to their environments
  • Author : Professor of Business Administration Paul C Nystrom,Paul C. Nystrom,William H. Starbuck
  • Publisher :Unknown
  • Release Date :1981
  • Total pages :582
  • ISBN : STANFORD:36105004682535
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Summary : The two volumes summarize and reinterpret research and suggest applications to the design of organizations. Volume I analyses the effects of environments on organizations, and discusses the adaptive capabilities of organizations such as planning, forecasting, and innovation.

Statistical Analysis with Missing Data

Statistical Analysis with Missing Data
  • Author : Roderick J. A. Little,Donald B. Rubin
  • Publisher :Unknown
  • Release Date :2019-04-30
  • Total pages :448
  • ISBN : 9780470526798
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Summary : An up-to-date, comprehensive treatment of a classic text on missing data in statistics The topic of missing data has gained considerable attention in recent decades. This new edition by two acknowledged experts on the subject offers an up-to-date account of practical methodology for handling missing data problems. Blending theory and application, authors Roderick Little and Donald Rubin review historical approaches to the subject and describe simple methods for multivariate analysis with missing values. They then provide a coherent theory for analysis of problems based on likelihoods derived from statistical models for the data and the missing data mechanism, and then they apply the theory to a wide range of important missing data problems. Statistical Analysis with Missing Data, Third Edition starts by introducing readers to the subject and approaches toward solving it. It looks at the patterns and mechanisms that create the missing data, as well as a taxonomy of missing data. It then goes on to examine missing data in experiments, before discussing complete-case and available-case analysis, including weighting methods. The new edition expands its coverage to include recent work on topics such as nonresponse in sample surveys, causal inference, diagnostic methods, and sensitivity analysis, among a host of other topics. An updated “classic” written by renowned authorities on the subject Features over 150 exercises (including many new ones) Covers recent work on important methods like multiple imputation, robust alternatives to weighting, and Bayesian methods Revises previous topics based on past student feedback and class experience Contains an updated and expanded bibliography Statistical Analysis with Missing Data, Third Edition is an ideal textbook for upper undergraduate and/or beginning graduate level students of the subject. It is also an excellent source of information for applied statisticians and practitioners in government and industry.