Design And Analysis Of Animal Studies In Pharmaceutical Development
Design And Analysis Of Animal Studies In Pharmaceutical Development Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Design And Analysis Of Animal Studies In Pharmaceutical Development book. This book definitely worth reading, it is an incredibly well-written.
Design and Analysis of Animal Studies in Pharmaceutical Development by Shein-Chung Chow,Jen-pei Liu Pdf
"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "
National Research Council,Institute of Medicine,Institute for Laboratory Animal Research,Commission on Life Sciences,Committee on the Use of Laboratory Animals in Biomedical and Behavioral Research
Author : National Research Council,Institute of Medicine,Institute for Laboratory Animal Research,Commission on Life Sciences,Committee on the Use of Laboratory Animals in Biomedical and Behavioral Research Publisher : National Academies Press Page : 113 pages File Size : 55,5 Mb Release : 1988-02-01 Category : Science ISBN : 9780309038393
Use of Laboratory Animals in Biomedical and Behavioral Research by National Research Council,Institute of Medicine,Institute for Laboratory Animal Research,Commission on Life Sciences,Committee on the Use of Laboratory Animals in Biomedical and Behavioral Research Pdf
Scientific experiments using animals have contributed significantly to the improvement of human health. Animal experiments were crucial to the conquest of polio, for example, and they will undoubtedly be one of the keystones in AIDS research. However, some persons believe that the cost to the animals is often high. Authored by a committee of experts from various fields, this book discusses the benefits that have resulted from animal research, the scope of animal research today, the concerns of advocates of animal welfare, and the prospects for finding alternatives to animal use. The authors conclude with specific recommendations for more consistent government action.
Design and Analysis of Animal Studies in Pharmaceutical Development by Shein-Chung Chow,Jen-pei Liu Pdf
"Provides well-integrated, comprehensive coverage of all the major statistical designs and methods used for animal studies in pharmaceutical research and development. Demonstrates the correct way to interpret the results of animal studies in the risk assessment of biopharmaceutical products and clarifies detailed presentations with real-world examples. "
Author : Simon T. Bate,Robin A. Clark Publisher : Cambridge University Press Page : 327 pages File Size : 51,9 Mb Release : 2014-03-13 Category : Computers ISBN : 9781107030787
Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Author : Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Publisher : National Academies Press Page : 107 pages File Size : 43,5 Mb Release : 2014-02-06 Category : Medical ISBN : 9780309292498
Improving and Accelerating Therapeutic Development for Nervous System Disorders by Institute of Medicine,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf
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.
Experimental Design and Reproducibility in Preclinical Animal Studies by José M. Sánchez Morgado,Aurora Brønstad Pdf
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.
Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy
Author : Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy Publisher : John Wiley & Sons Page : 598 pages File Size : 43,5 Mb Release : 2016-04-18 Category : Medical ISBN : 9781119053330
Drug Discovery Toxicology by Yvonne Will,J. Eric McDuffie,Andrew J. Olaharski,Brandon D. Jeffy Pdf
As a guide for pharmaceutical professionals to the issues and practices of drug discovery toxicology, this book integrates and reviews the strategy and application of tools and methods at each step of the drug discovery process. • Guides researchers as to what drug safety experiments are both practical and useful • Covers a variety of key topics – safety lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal models, biomarkers, and –omics tools • Describes what experiments are possible and useful and offers a view into the future, indicating key areas to watch for new predictive methods • Features contributions from firsthand industry experience, giving readers insight into the strategy and execution of predictive toxicology practices
Animal Models for Human Cancer by Marianne I. Martic-Kehl,Pius August Schubiger Pdf
Based on results from the past ten years, this ready reference systematically describes how to prepare, carry out, and evaluate animal studies for cancer therapies, addressing the widely recognized lack of reliable and reproducible results. Following a short historical introduction and a discussion of the ethics surrounding animal experiments, the book describes correct study design as well as the handling and housing of animals. It then goes on to describe the animal models available for different cancer types, from natural cancer models in mice and dogs to humanized animals. An evaluation of previously unpublished long-term data from the Swiss canine and feline cancer registry is also included. The final part of the book reviews the lessons learned over the last decade on how to interpret data from animal studies for improving human therapy and gives recommendations for future drug development.
Design and Analysis of Bioavailability and Bioequivalence Studies by Shein-Chung Chow,Jen-pei Liu Pdf
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
National Research Council,Institute of Medicine,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Policy and Global Affairs,Committee on Science, Technology, and Law,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders
Author : National Research Council,Institute of Medicine,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Policy and Global Affairs,Committee on Science, Technology, and Law,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Publisher : National Academies Press Page : 102 pages File Size : 49,8 Mb Release : 2012-06-26 Category : Science ISBN : 9780309252119
International Animal Research Regulations by National Research Council,Institute of Medicine,Division on Earth and Life Studies,Institute for Laboratory Animal Research,Policy and Global Affairs,Committee on Science, Technology, and Law,Board on Health Sciences Policy,Forum on Neuroscience and Nervous System Disorders Pdf
Animals are widely used in neuroscience research to explore biological mechanisms of nervous system function, to identify the genetic basis of disease states, and to provide models of human disorders and diseases for the development of new treatments. To ensure the humane care and use of animals, numerous laws, policies, and regulations are in place governing the use of animals in research, and certain animal regulations have implications specific to neuroscience research. To consider animal research regulations from a global perspective, the IOM Forum on Neuroscience and Nervous System Disorders, in collaboration with the National Research Council and the Institute for Laboratory Animal Research, held a workshop in Buckinghamshire, UK, July 26-27, 2011. The workshop brought together neuroscientists, legal scholars, administrators, and other key stakeholders to discuss current and emerging trends in animal regulations as they apply to the neurosciences. This document summarizes the workshop.
Animal Experimentation: Working Towards a Paradigm Change by Kathrin Herrmann,Kimberley Jayne Pdf
Animal experimentation has been one of the most controversial areas of animal use, mainly due to the intentional harms inflicted upon animals for the sake of hoped-for benefits in humans. Despite this rationale for continued animal experimentation, shortcomings of this practice have become increasingly more apparent and well-documented. However, these limitations are not yet widely known or appreciated, and there is a danger that they may simply be ignored. The 51 experts who have contributed to Animal Experimentation: Working Towards a Paradigm Change critically review current animal use in science, present new and innovative non-animal approaches to address urgent scientific questions, and offer a roadmap towards an animal-free world of science.
Quantitative Methods for Traditional Chinese Medicine Development by Shein-Chung Chow Pdf
A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world’s most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency. It also contains an entire chapter of case studies and addresses critical issues in TCM development and FAQs from a regulatory perspective.
Statistical Design and Analysis of Stability Studies by Shein-Chung Chow Pdf
The US Food and Drug Administration's Report to the Nation in 2004 and 2005 indicated that one of the top reasons for drug recall was that stability data did not support existing expiration dates. Pharmaceutical companies conduct stability studies to characterize the degradation of drug products and to estimate drug shelf life. Illustrating how sta
Multiregional Clinical Trials for Simultaneous Global New Drug Development by Joshua Chen,Hui Quan Pdf
In a global clinical development strategy, multiregional clinical trials (MRCTs) are vital in the development of innovative medicines. Multiregional Clinical Trials for Simultaneous Global New Drug Development presents a comprehensive overview on the current status of conducting MRCTs in clinical development. International experts from academia, in
Animal and Translational Models for CNS Drug Discovery: Neurological Disorders by Robert A. McArthur,Franco Borsini Pdf
Neurological Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for neurological disorders such as neurofibromatosis, Alzheimer’s disease, Parkinson’s disease, Huntington disease, ALS, and the epilepsies. Neurological Disorders has introductory chapters expressing the view of the role and relevance of animal models for drug discovery and development for the treatment of psychiatric disorders from the perspective of (a) academic basic neuroscientific research, (b) applied pharmaceutical drug discovery and development, and (c) issues of clinical trial design and regulatory agencies limitations. Each volume examines the rationale, use, robustness and limitations of animal models in each therapeutic area covered and discuss the use of animal models for target identification and validation. The clinical relevance of animal models is discussed in terms of major limitations in cross-species comparisons, clinical trial design of drug candidates, and how clinical trial endpoints could be improved. The aim of this series of volumes on Animal and Translational Models for CNS Drug Discovery is to identify and provide common endpoints between species that can serve to inform both the clinic and the bench with the information needed to accelerate clinically-effective CNS drug discovery. This is the second volume in the three volume-set, Animal and Translational Models for CNS Drug Discovery 978-0-12-373861-5, which is also available for purchase individually. Clinical, academic, government and industry perspectives fostering integrated communication between principle participants at all stages of the drug discovery process Critical evaluation of animal and translational models improving transition from drug discovery and clinical development Emphasis on what results mean to the overall drug discovery process Exploration of issues in clinical trial design and conductance in each therapeutic area
