Download or read book Good Research Practice in Non Clinical Pharmacology and Biomedicine written by Anton Bespalov and published by Springer Nature. This book was released on 2020-01-01 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Download or read book Good Research Practice in Non clinical Pharmacology and Biomedicine written by and published by . This book was released on 2020 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
Download or read book The Role of the Study Director in Nonclinical Studies written by William J. Brock and published by John Wiley & Sons. This book was released on 2014-06-03 with total page 568 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.
Download or read book Research Ethics written by Ana Smith Iltis and published by Routledge. This book was released on 2006-01-16 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Medicine in the twenty-first century is increasingly reliant on research to guarantee the safety and efficacy of medical interventions. As a result, the need to understand the ethical issues that research generates is becoming essential. This volume introduces the principal areas of concern in research on human subjects, offering a framework for understanding research ethics, and the relationship between ethics and compliance. Research Ethics brings together leading scholars in bioethics and the topics covered include the unique concerns that arise in specific areas of research such as gene therapy and stem cell research. Individual chapters also address the ethical issues that occur when conducting research with specific populations such as infants or adolescents, and the volume looks at important emerging questions in human subjects research, namely financial conflicts of interest and the interpretation of scientific data.
Download or read book Reconstructing Research Integrity written by Barbara Redman and published by Springer Nature. This book was released on 2023-03-23 with total page 212 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book exposes significant threats to research integrity and identifies policies and practices that can reverse these trends. It is focused on human research and US policy. Recent assessments have shown inadequacies in institutions, policies, and practices that seriously compromise ethics. The presumed self-regulatory nature of the scientific endeavor has been exposed to have allowed unabated areas of poor-quality science, an incomplete and inaccessible scientific record, conflicts of interest, differing notions of accountability, virtually no evidence base to direct research integrity policy, and a growing sense of alienation, moral injury and even revolt among scientists. Reconstructing Research Integrity aims to capture ways of vigorously moving toward scientific and ethical rigor, including self-correction and emerging or already-successful initiatives. The book begins with analysis of the full system of institutions, policies, and practices involved in production, dissemination, and application of research, including an examination of the blind spots in research ethics ideology, policy, and practice. The book then identifies policies and practices that can reverse harmful ethical trends, such as strengthening Responsible Conduct of Research (RCR) training and improving self-regulation in the scientific community. Finally, the book discusses the constant evolution of research ethics and integrity, which is illustrated by emerging research fields like gene editing and data science. This book will be of interest to all research administrators in academic, commercial and government positions; to policy advisors at the National Science Foundation and at the National Academies of Science, Engineering, and Medicine; to graduate students in research ethics; to advanced bioethics education programs across the globe; and to researchers and consultants in ELSI (ethical, legal, and social implications) programs.
Download or read book Sample Size Calculations in Clinical Research written by Shein-Chung Chow and published by CRC Press. This book was released on 2017-08-15 with total page 954 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Oxford Handbook of Medical Sciences written by Robert Wilkins and published by OUP Oxford. This book was released on 2011-09-22 with total page 990 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by biomedical scientists and clinicians, with the purpose of disseminating the fundamental scientific principles that underpin medicine, this new edition of the Oxford Handbook of Medical Sciences provides a clear, easily digestible account of basic cell physiology and biochemistry. It also includes an investigation of the traditional pillars of medicine (anatomy, physiology, biochemistry, pathology and pharmacology) integrated in the context of each of the major systems relevant to the human body. Cross-referenced to the Oxford Handbook of Clinical Medicine, and thoroughly illustrated, it is the ideal introduction to the medical sciences for medical students and biomedical scientists, as well as a valuable refresher for junior doctors.
Download or read book Topics in Anti Cancer Research Volume 10 written by Atta-ur-Rahman and published by Bentham Science Publishers. This book was released on 2021-12-13 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: Topics in Anti-Cancer Research covers new developments in the field of cancer diagnosis and drug therapy. Novel drugs as anticancer agents include natural and synthetic phenazirines and other anti-cancer compounds. The series also covers information on the current understanding of the pathology and molecular biology of specific neoplasms. The diversity of research topics published in this book series give broad and valuable perspectives for cancer researchers, clinicians, cancer professionals aiming to develop novel anti-cancer targets and patents for the treatment of various cancers. The topics covered in this volume are: - Peptides can play a major role in combating cancer diseases - Studying of the CLL after treatment using fractal parameter of neoplastic lymphocytes detection (ΛNLD) - Mechanistic insight of rhenium-based compounds as anti- cancer agents - Targeting cancer-specific inflammatory components in cancer therapeutics - Marine natural products as a source of novel anticancer agents: a treasure from the ocean - PDX clinical trial design in anti-cancer research
Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Avoiding Questionable Research Practices in Applied Psychology written by William O'Donohue and published by Springer Nature. This book was released on 2022-08-23 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: This authoritative volume presents a detailed analysis of the replication crisis and the use of questionable research practices (QRPs) in psychology, as well as recommended practices for combatting these problems. Ultimately, the book aims to provide a comprehensive, current, and accessible account of the adverse effects of QRPs. The replication crisis in psychology and allied fields has exposed critical flaws in the standard views of research methods, which allow for extensive flexibility in data analysis by investigators and permit the widespread use of QRPs. Chapters examine the intentional use of QRPs such as data fabrication and falsification, along with subtler, unintentional practices such as p-hacking and HARKING (hypothesizing after results are known). Drawing on the growing awareness of these problems, contributors also highlight potential strategies to detect QRPs and minimize their negative impact through open data practices, preregistration of hypotheses and analyses, and adversarial collaborations, in which investigators holding opposing positions on a scientific issue agree to work together on a study in an effort to counteract their respective biases. Among the topics covered: History of controversies in statistics and replication Embracing intellectual humility while designing research Confirmatory vs. exploratory analyses Publication bias and negative results Promoting honest and transparent report writing Avoiding Questionable Research Practices in Applied Psychology provides a deeper understanding of how QRPs impede the reliability and trustworthiness of findings in psychology and the social sciences. It will be a practical, useful resource for students and instructors in graduate and advanced undergraduate level research methods classes, along with psychological researchers interested in improving their own research.
Download or read book Children and Clinical Research written by and published by . This book was released on 2015 with total page 221 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Rethinking Health Care Ethics written by Stephen Scher and published by Springer. This book was released on 2018-08-02 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: The goal of this open access book is to develop an approach to clinical health care ethics that is more accessible to, and usable by, health professionals than the now-dominant approaches that focus, for example, on the application of ethical principles. The book elaborates the view that health professionals have the emotional and intellectual resources to discuss and address ethical issues in clinical health care without needing to rely on the expertise of bioethicists. The early chapters review the history of bioethics and explain how academics from outside health care came to dominate the field of health care ethics, both in professional schools and in clinical health care. The middle chapters elaborate a series of concepts, drawn from philosophy and the social sciences, that set the stage for developing a framework that builds upon the individual moral experience of health professionals, that explains the discontinuities between the demands of bioethics and the experience and perceptions of health professionals, and that enables the articulation of a full theory of clinical ethics with clinicians themselves as the foundation. Against that background, the first of three chapters on professional education presents a general framework for teaching clinical ethics; the second discusses how to integrate ethics into formal health care curricula; and the third addresses the opportunities for teaching available in clinical settings. The final chapter, "Empowering Clinicians", brings together the various dimensions of the argument and anticipates potential questions about the framework developed in earlier chapters.
Download or read book Translational Orthopedics written by Jeffrey A. Bakal and published by Elsevier. This book was released on 2024-04-26 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Orthopedics: Designing and Conducting Translational Research covers the principles of evidence-based medicine and applies these principles to the design of translational investigations. The reader will come to fully understand important concepts including case-control study, prospective cohort study, randomized trial, and reliability study. Medical researchers will benefit from greater confidence in their ability to initiate and execute their own investigations, avoid common pitfalls in translational orthopedics, and know what is needed in collaboration. Further, this title is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps the aspiring investigator navigate challenging considerations in study design and implementation. The book provides valuable discussions of the critical appraisal of published studies in translational orthopedics, allowing the reader to learn how to evaluate the quality of such studies with respect to measuring outcomes and to make effective use of all types of evidence in patient care. In short, this practical guidebook will be of interest to every Medical Researcher or Orthopedist who has ever had a good clinical idea but not the knowledge of how to test it. Focuses on the principles of evidence-based medicine and applies these principles to the design of translational investigations within orthopedics Provides a practical, straightforward approach that helps investigators navigate challenging considerations in study design and implementation Details discussions of the critical appraisal of published studies in translational orthopedics, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care
Download or read book A Guide to Sample Size for Animal based Studies written by Penny S. Reynolds and published by John Wiley & Sons. This book was released on 2023-08-29 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Guide to Sample Size for Animal-based Studies Understand a foundational area of experimental design with this innovative reference Animal-based research is an essential part of basic and preclinical research, but poses a unique set of experimental design challenges. The most important of these are the 3Rs − Replacement, Reduction and Refinement − the principles comprising the ethical framework for humane animal-based studies. However, many researchers have difficulty navigating the design trade-offs necessary to simultaneously minimize animal use, and produce scientific information that is both rigorous and reliable. A Guide to Sample Size for Animal-based Studies meets this need with a thorough, accessible reference work to the subject. This book provides a straightforward systematic approach to “rightsizing” animal-based experiments, with sample size estimates based on the fundamentals of statistical thinking: structured research questions, variation control and appropriate design of experiments. The result is a much-needed guide to planning animal-based experiments to ensure scientifically valid and reliable results. This book offers: Step-by-step guidance in diverse methods for approximating and refining sample size Detailed treatment of research topics specific to animal-based research, including pilot, feasibility and proof-of-concept studies Sample size approximation methods for different types of data − binary, continuous, ordinal, time to event − and different study types − description, comparison, nested designs, reference interval construction and dose-response studies Numerous worked examples, using real data from published papers, together with SAS and R code A Guide to Sample Size for Animal-based Studies is a must-have reference for preclinical and veterinary researchers, as well as ethical oversight committees and policymakers.
Download or read book Translational Medicine written by Joy A. Cavagnaro and published by CRC Press. This book was released on 2021-11-26 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Medicine: Optimizing Preclinical Safety Evaluation of Biopharmaceuticals provides scientists responsible for the translation of novel biopharmaceuticals into clinical trials with a better understanding of how to navigate the obstacles that keep innovative medical research discoveries from becoming new therapies or even making it to clinical trials. The book includes sections on protein-based therapeutics, modified proteins, oligonucleotide-based therapies, monoclonal antibodies, antibody–drug conjugates, gene and cell-based therapies, gene-modified cell-based therapies, combination products, and therapeutic vaccines. Best practices are defined for efficient discovery research to facilitate a science-based, efficient, and predictive preclinical development program to ensure clinical efficacy and safety. Key Features: Defines best practices for leveraging of discovery research to facilitate a development program Includes general principles, animal models, biomarkers, preclinical toxicology testing paradigms, and practical applications Discusses rare diseases Discusses "What-Why-When-How" highlighting different considerations based upon product attributes. Includes special considerations for rare diseases About the Editors Joy A. Cavagnaro is an internationally recognized expert in preclinical development and regulatory strategy with an emphasis on genetic medicines.. Her 40-year career spans academia, government (FDA), and the CRO and biotech industries. She was awarded the 2019 Arnold J Lehman Award from the Society of Toxicology for introducing the concept of science-based, case-by-case approach to preclinical safety evaluation, which became the foundation of ICH S6. She currently serves on scientific advisory boards for advocacy groups and companies and consults and lectures in the area of preclinical development of novel therapies. Mary Ellen Cosenza is a regulatory toxicology consultant with over 30 years of senior leadership experience in the biopharmaceutical industry in the U.S., Europe, and emerging markets. She has held leadership position in both the American College of Toxicology (ACT) and the International Union of Toxicology (IUTOX) and is also an adjunct assistant professor at the University of Southern California where she teaches graduate-level courses in toxicology and regulation of biologics.
Download or read book Organotypic Models in Drug Development written by Monika Schäfer-Korting and published by Springer Nature. This book was released on 2021-03-25 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides latest findings in organotypic models in drug development and provides the scientific resonance needed in an emerging field of research in disciplines, such as molecular medicine, physiology, and pathophysiology. Today the research on human-based test systems has gained major interest and funding in the EU and the US has increased over the last years. Moreover, so-called 3R (reduce, replace, refine animal experiments) centres have been established worldwide.
