Good Research Practice In Non Clinical Pharmacology And Biomedicine

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.

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.

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.

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

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

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.

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 "right-sizing" 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.

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