Good Research Practice in Non-Clinical Pharmacology and Biomedicine PDF Download

Author: Anton Bespalov
Publisher: Springer Nature
ISBN: 3030336565
Category : Cardiology
Languages : en
Pages : 424

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Book Description
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.

Author:
Publisher:
ISBN: 9783030336578
Category : Drugs
Languages : en
Pages : 424

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Book Description
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.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309292492
Category : Medical
Languages : en
Pages : 118

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Book Description
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.

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498511
Category : Medical
Languages : en
Pages : 103

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Book Description
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.

Author: Barbara Redman
Publisher: Springer Nature
ISBN: 3031271114
Category : Study Aids
Languages : en
Pages : 212

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Book Description
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: Prashant Kesharwani
Publisher: Academic Press
ISBN: 0128204672
Category : Medical
Languages : en
Pages : 542

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Book Description
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

Author: Atta-ur-Rahman
Publisher: Bentham Science Publishers
ISBN: 981503930X
Category : Medical
Languages : en
Pages : 169

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Book Description
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

Author: William O'Donohue
Publisher: Springer Nature
ISBN: 3031049683
Category : Psychology
Languages : en
Pages : 439

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Book Description
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.

Author: Alexandru Mihai Grumezescu
Publisher: William Andrew
ISBN: 0128172614
Category : Medical
Languages : en
Pages : 720

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Book Description
Nanoarchitectonics in Biomedicine describes this new area of nanoscience that has emerged as a major branch of nanoscience. The book brings together recent applications and discusses the advantages and disadvantages of each process, offering international perspectives on the technologies based on these findings. It offers new insights for nanoarchitectonics, starting with the currently used methods of synthesis and characterization of such materials, along with their biomedical applications. Authored by a wide range of international scientists, this volume shows how nanoarchitectonics is being used to create more efficient medical treatment solutions. Users will find this to be an important research resource for those wanting to learn more on the emerging topic of nanoarchitectonics in biomedical science. Explores how design aspects, smart materials and personalized materials are used in biomedicine today Offers global perspectives on how nanoarchitectonics is used in different regions Presents an important research resource for those wanting to learn more on the emerging topic of nanoarchitectonics in biomedical science

Author: Jeffrey A. Bakal
Publisher: Elsevier
ISBN: 0323885624
Category : Science
Languages : en
Pages : 580

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Book Description
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