hands on approach for the conduct of nonclinical studies

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Targeted Therapy in Translational Cancer Research
Author : Apostolia-Maria Tsimberidou,Razelle Kurzrock,Kenneth C. Anderson
Publisher : John Wiley & Sons
Release Date : 2015-10-08
ISBN 10 : 1118468686
Pages : 320 pages
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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

Global Approach in Safety Testing
Author : Jan Willem van der Laan,Joseph J DeGeorge
Publisher : Springer Science & Business Media
Release Date : 2013-02-11
ISBN 10 : 1461459508
Pages : 315 pages
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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”.

Nonhuman Primates in Biomedical Research
Author : Christian R. Abee,Keith Mansfield,Suzette D. Tardif,Timothy Morris
Publisher : Academic Press
Release Date : 2012-05-09
ISBN 10 : 0123978378
Pages : 536 pages
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The 2e of the gold standard text in the field, Nonhuman Primates in Biomedical Research provides a comprehensive, up-to-date review of the use of nonhuman primates in biomedical research. The Biology and Management volume provides basic information on the natural biology of nonhuman primates and the current state of knowledge regarding captive management. Each chapter contains an extensive list of bibliographic references, photographs, and graphic illustrations to provide the reader with a thorough review of the subject. Now in four color throughout, making the book more visually stimulating to enhance learning and ease of use Fully revised and updated, providing researchers with the most comprehensive review of the use of nonhuman primates in biomedical research Addresses commonly used nonhuman primate biomedical models, providing researchers with species-specific information

The Role of the Study Director in Nonclinical Studies
Author : William J. Brock,Barbara Mounho,Lijie Fu
Publisher : John Wiley & Sons
Release Date : 2014-05-02
ISBN 10 : 1118874080
Pages : 560 pages
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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

Handbook
Author : World Health Organization
Publisher : World Health Organization
Release Date : 2010-02-02
ISBN 10 : 9241547553
Pages : 309 pages
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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.

Advances in Clinical Child Psychology
Author : Benjamin Lahey
Publisher : Springer Science & Business Media
Release Date : 2012-12-06
ISBN 10 : 1461398207
Pages : 326 pages
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A decade ago, Advances in Clinical Child Psychology was conceived to provide approximately annual updates on the forward edge of research and practice in this rapidly growing field. A look back at the 56 chapters published in previous volumes provides a broad overview of the direc tion of advancement in clinical child psychology, at least as viewed by one collection of editors, consulting editors, and authors. The trends are clear: There have been decreasing numbers of advances in modes and methods of therapy, an increasing emphasis on the family, a renewed interest in experimental psychopathology (studies of classification, etiol ogy, and prognosis), a growing rapprochement between biological and psychological perspectives, and continued strong interest in cognition and social relationships. The current volume clearly shows these directions in the growth of the field. One chapter discusses etiology, four are concerned with the psychopathology of specific diagnostic categories, one takes an ex panded cognitive approach to social competence, and two look at the family system by examining the effects of male parents and children on other members of the family. A final chapter opens discussion on the important topic of the nature of excellence in the training of clinical child psychologists. It is hoped that this chapter will initiate a national di alogue on this multifaceted and often neglected topic.

Oncology Clinical Trials
Author : Susan Halabi, PhD,Wm. Kevin Kelly, DO
Publisher : Demos Medical Publishing
Release Date : 2009-12-22
ISBN 10 : 9781935281764
Pages : 168 pages
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Clinical trials are the engine of progress in the development of new drugs and devices for the detection, monitoring, prevention and treatment of cancer. A well conceived, carefully designed and efficiently conducted clinical trial can produce results that change clinical practice overnight, deliver new oncology drugs and diagnostics to the marketplace, and expand the horizon of contemporary thinking about cancer biology. A poorly done trial does little to advance the field or guide clinical practice, consumes precious clinical and financial resources and challenges the validity of the ethical contract between investigators and the volunteers who willingly give their time and effort to benefit future patients. With chapters written by oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives, Oncology Clinical Trials, provides a comprehensive guide for both early-career and senior oncology investigators into the successful design, conduct and analysis of an oncology clinical trial. Oncology Clinical Trials covers how to formulate a study question, selecting a study population, study design of Phase I, II, and III trials, toxicity monitoring, data analysis and reporting, use of genomics, cost-effectiveness analysis, systemic review and meta-analysis, and many other issues. Many examples of real-life flaws in clinical trials that have been reported in the literature are included throughout. The book discusses clinical trials from start to finish focusing on real-life examples in the development, design and analysis of clinical trials. Oncology Clinical Trials features: A systematic guide to all aspects of the design, conduct, analysis, and reporting of clinical trials in oncology Contributions from oncologists, researchers, biostatisticians, clinical research administrators, and industry and FDA representatives Hot topics in oncology trials including multi-arm trials, meta-analysis and adaptive design, use of genomics, and cost-effectiveness analysis Real-life examples from reported clinical trials included throughout

Valuation in Life Sciences
Author : Boris Bogdan,Ralph Villiger
Publisher : Springer Science & Business Media
Release Date : 2008-03-29
ISBN 10 : 9783540782483
Pages : 334 pages
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This is the first complete guide to valuation in life sciences for industry professionals, investors, and academics. Boris Bogdan and Ralph Villiger introduce the characteristics of drug and medical device development, explain how to translate these into the valuation, and provide valuable industry data. Special emphasis is put on the practicability of the proposed methods by including many hands-on examples, without compromising on realistic results.

Cancer Gene Therapy
Author : David T. Curiel,Joanne T. Douglas
Publisher : Springer Science & Business Media
Release Date : 2007-11-03
ISBN 10 : 1592597858
Pages : 490 pages
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A complete introduction and guide to the latest developments in cancer gene therapy-from bench to bedside. The authors comprehensively review the anticancer genes and gene delivery methods currently available for cancer gene therapy, including the transfer of genetic material into the cancer cells, stimulation of the immune system to recognize and eliminate cancer cells, and the targeting of the nonmalignant stromal cells that support their growth. They also thoroughly examine the advantages and limitations of the different therapies and detail strategies to overcome obstacles to their clinical implementation. Topics of special interest include vector-targeting techniques, the lessons learned to date from clinical trials of cancer gene therapy, and the regulatory guidelines for future trials. Noninvasive techniques to monitor the extent of gene transfer and disease regression during the course of treatment are also discussed.

Psychological Abstracts
Author : American psychological association
Publisher : N.A
Release Date : 2003
ISBN 10 :
Pages : 329 pages
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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 : National Academies Press
Release Date : 2017-07-26
ISBN 10 : 0309457769
Pages : 342 pages
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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.

Pharmaceutical Toxicology in Practice
Author : Alberto Lodola,Jeanne Stadler
Publisher : John Wiley & Sons
Release Date : 2011-03-31
ISBN 10 : 0470922729
Pages : 280 pages
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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.

OECD Guidelines for Testing of Chemicals
Author : Organisation for Economic Co-operation and Development
Publisher : Organisation for Economic Co-operation and Development ; [Montréal : Renouf]
Release Date : 1981
ISBN 10 : 9789264122215
Pages : 329 pages
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Small Clinical Trials
Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Strategies for Small-Number-Participant Clinical Research Trials
Publisher : National Academies Press
Release Date : 2001-01-01
ISBN 10 : 9780309171144
Pages : 222 pages
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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
Author : Ronald D. Hood,Ronald D Hood
Publisher : CRC Press
Release Date : 2005-08-30
ISBN 10 : 1420040545
Pages : 1168 pages
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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.

Science, Medicine, and Animals
Author : National Research Council,Division on Earth and Life Studies,Institute for Laboratory Animal Research
Publisher : National Academies Press
Release Date : 2006-01-19
ISBN 10 : 9780309181990
Pages : 23 pages
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Science, Medicine, and Animals explains the role that animals play in biomedical research and the ways in which scientists, governments, and citizens have tried to balance the experimental use of animals with a concern for all living creatures. An accompanying Teacher’s Guide is available to help teachers of middle and high school students use Science, Medicine, and Animals in the classroom. As students examine the issues in Science, Medicine, and Animals, they will gain a greater understanding of the goals of biomedical research and the real-world practice of the scientific method in general. Science, Medicine, and Animals and the Teacher’s Guide were written by the Institute for Laboratory Animal Research and published by the National Research Council of the National Academies. The report was reviewed by a committee made up of experts and scholars with diverse perspectives, including members of the U.S. Department of Agriculture, National Institutes of Health, the Humane Society of the United States, and the American Society for the Prevention of Cruelty to Animals. The Teacher’s Guide was reviewed by members of the National Academies’ Teacher Associates Network. Science, Medicine, and Animals is recommended by the National Science Teacher’s Association NSTA Recommends.

Handbook for Good Clinical Research Practice (GCP)
Author : World Health Organization
Publisher : N.A
Release Date : 2005
ISBN 10 : 9789241593922
Pages : 125 pages
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Improving and Accelerating Therapeutic Development for Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Publisher : National Academies Press
Release Date : 2014-02-06
ISBN 10 : 0309292492
Pages : 118 pages
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Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

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 : National Academies Press
Release Date : 2016-01-09
ISBN 10 : 0309379903
Pages : 82 pages
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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.

Biotechnology, Recombinant Proteins, Monoclonal Antibodies, and Therapeutic Genes
Author : A. Mountain,U. M. Ney,Dietmar Schomburg
Publisher : Wiley-Blackwell
Release Date : 1999-03-19
ISBN 10 : 9783527283156
Pages : 580 pages
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In the field of medicinal biotechnology three major developments have caused a revolution in research that has a lot of innovative effects on clinical medicine and future applications on humans. With the availability of tailored recombinant proteins and the opportunity to produce high amounts of monoclonal antibodies new diagnostic applications have emerged and many therapeutic perspectives, e.g. in the treatment of multiple sclerosis and of cancer, are being discussed today. The aim of somatic gene therapy is to re-establish normal cell function by supplying the cells with the respective intact gene. This is a very difficult task and different diseases, e.g. AIDS and several metabolic disorders, are under investigation now. So far first promising approaches exist in cancer therapy. Moreover the book informs about regulatory and economic aspects of these new methods and their applications.