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Good Research Practice In Non Clinical Pharmacology And Biomedicine
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Book Synopsis Good Research Practice in Non-Clinical Pharmacology and Biomedicine by : Anton Bespalov
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.
Book Synopsis Good Research Practice in Non-clinical Pharmacology and Biomedicine by :
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.
Book Synopsis Reconstructing Research Integrity by : Barbara Redman
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.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309498511 Total Pages :103 pages Book Rating :4.3/5 (94 download)
Book Synopsis The Role of NIH in Drug Development Innovation and Its Impact on Patient Access by : National Academies of Sciences, Engineering, and Medicine
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.
Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine
Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Research Ethics by : Ana Smith Iltis
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.
Book Synopsis Topics in Anti-Cancer Research: Volume 10 by : Atta-ur-Rahman
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
Book Synopsis Avoiding Questionable Research Practices in Applied Psychology by : William O'Donohue
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.
Book Synopsis Theory and Applications of Nonparenteral Nanomedicines by : Prashant Kesharwani
Download or read book Theory and Applications of Nonparenteral Nanomedicines written by Prashant Kesharwani and published by Academic Press. This book was released on 2020-09-12 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: Theory and Applications of Nonparenteral Nanomedicines presents thoroughly analysed data and results regarding the potential of nanomedicines conceived by diverse non-parenteral routes. In the context of nanotechnology-based approaches, various routes such as oral, pulmonary, transdermal, delivery and local administration of nanomedicine have been utilized for the delivery of nanomedicine. This book discusses the non-parenteral application of nanomedicine, its regulatory implications, application of mucus penetrating nanocarrier, and detailed chapters on development of nanomedicines developed for drug delivery by various route. Beginning with a brief introduction to the non-parenteral delivery of nanomedicine and the safety and regulatory implications of the nanoformulations, further chapters discuss the physiology of the biological barriers, the specificity of the nanocarriers as well as their multiple applications. Theory and Applications of Nonparenteral Nanomedicines helps clinical researchers, researchers working in pharmaceutical industries, graduate students, and anyone working in the development of non-parenteral nanomedicines to understand the recent progress in the design and development of nanoformulations compatible with non-parenteral applications. Contains a comprehensive review of non-parenteral nanomedicines Provides analysis of non-parenteral methods of nanomedicines including regulatory implications and future applications Explores a wide range of promising approaches for non-parenteral drug delivery using the latest advancement in nanomedicine written by experts in industry and academia
Book Synopsis Translational Orthopedics by : Jeffrey A. Bakal
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
Book Synopsis A Guide to Sample Size for Animal-based Studies by : Penny S. Reynolds
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.
Book Synopsis Translational Medicine by : Joy A. Cavagnaro
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.
Book Synopsis Organotypic Models in Drug Development by : Monika Schäfer-Korting
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.
Book Synopsis Translational Interventional Radiology by : Adam E.M. Eltorai
Download or read book Translational Interventional Radiology written by Adam E.M. Eltorai and published by Elsevier. This book was released on 2023-04-05 with total page 600 pages. Available in PDF, EPUB and Kindle. Book excerpt: Translational Interventional Radiology, a volume in the Handbook for Designing and Conducting Clinical and Translational Research series, covers the principles of evidence-based medicine and applies these principles to the design of translational investigations in Interventional Radiology. 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 Interventional Radiology, and know what is needed for successful collaboration. Further, this reference is an indispensable tool in grant writing and funding efforts. The practical, straightforward approach helps aspiring investigators navigate challenging considerations in study design and implementation. This book provides valuable discussions of the critical appraisal of published studies in Interventional Radiology, elucidating the evaluation of the quality with respect to measuring outcomes and making effective use of all types of evidence in patient care. In short, this practical guide will be of interest to every medical researcher and interventional radiologist 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 interventional radiology 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 interventional radiology, supporting evaluation with respect to measuring outcomes and making effective use of all types of evidence in patient care
Book Synopsis Experimental Design and Reproducibility in Preclinical Animal Studies by : José M. Sánchez Morgado
Download or read book Experimental Design and Reproducibility in Preclinical Animal Studies written by José M. Sánchez Morgado and published by Springer Nature. This book was released on 2021-08-31 with total page 277 pages. Available in PDF, EPUB and Kindle. Book excerpt: This highly-readable text provides grounds on how to plan and conduct animal experiments that can be reproduced by others. The book touches on factors that may impact the reproducibility of animal studies including: the animal genetic background, the animal microbial flora, environmental and physiological variables affecting the animal, animal welfare, statistics and experimental design, systematic reviews of animal studies, and the publishing process. The book addresses advanced undergraduates, graduate students and all scientists working with animals.
Book Synopsis Proceedings of TAKE 2021 Conference by : Carla Lobo
Download or read book Proceedings of TAKE 2021 Conference written by Carla Lobo and published by Eduardo Tomé. This book was released on 2021-07-10 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt: Foreword This volume includes papers presented at TAKE 2021 Conference The Multidisciplinary Conference on Intangibles, held online between the 7 th and the 9th July 2021 and hosted by Universidade Portucalense, from Porto, Portugal. Detailed information about the Conference is to be found in the Conference Website: https://take-conference2021.com/. A Book of Abstracts was also published. TAKE 2021 included 80 presentations, by almost 100 participants, including 8 keynote speakers, from 20 countries. Done during the Covid-19 crisis, TAKE 2021 was a show of intelligence, work, and solidarity, We thank infinitely all those involved, which contributed to the success of the event. We hope to continue the TAKE saga, next year with TAKE 2022 whose website is already online: https://take-conference2022.com/. Best wishes and kindest regards. Eduardo Tomé, on behalf of the Organizing Committee
Book Synopsis Encyclopedia of Data Science and Machine Learning by : Wang, John
Download or read book Encyclopedia of Data Science and Machine Learning written by Wang, John and published by IGI Global. This book was released on 2023-01-20 with total page 3296 pages. Available in PDF, EPUB and Kindle. Book excerpt: Big data and machine learning are driving the Fourth Industrial Revolution. With the age of big data upon us, we risk drowning in a flood of digital data. Big data has now become a critical part of both the business world and daily life, as the synthesis and synergy of machine learning and big data has enormous potential. Big data and machine learning are projected to not only maximize citizen wealth, but also promote societal health. As big data continues to evolve and the demand for professionals in the field increases, access to the most current information about the concepts, issues, trends, and technologies in this interdisciplinary area is needed. The Encyclopedia of Data Science and Machine Learning examines current, state-of-the-art research in the areas of data science, machine learning, data mining, and more. It provides an international forum for experts within these fields to advance the knowledge and practice in all facets of big data and machine learning, emphasizing emerging theories, principals, models, processes, and applications to inspire and circulate innovative findings into research, business, and communities. Covering topics such as benefit management, recommendation system analysis, and global software development, this expansive reference provides a dynamic resource for data scientists, data analysts, computer scientists, technical managers, corporate executives, students and educators of higher education, government officials, researchers, and academicians.
