Model Informed Drug Development And Evidence Based Translational Pharmacology


Model Informed Drug Development And Evidence Based Translational Pharmacology
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Model Informed Drug Development And Evidence Based Translational Pharmacology


Model Informed Drug Development And Evidence Based Translational Pharmacology
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Author : Yu-Wei Lin
language : en
Publisher: Frontiers Media SA
Release Date : 2023-01-12

Model Informed Drug Development And Evidence Based Translational Pharmacology written by Yu-Wei Lin and has been published by Frontiers Media SA this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-12 with Science categories.




Translational Medicine And Drug Discovery


Translational Medicine And Drug Discovery
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Author : Bruce H. Littman
language : en
Publisher: Cambridge University Press
Release Date : 2011-01-31

Translational Medicine And Drug Discovery written by Bruce H. Littman and has been published by Cambridge University Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-01-31 with Medical categories.


This book focuses on the new discipline of translational medicine as it pertains to drug development within the pharmaceutical and biotechnology industry. It is essential for anyone interested in translational medicine from a variety of backgrounds: university institutes, medical schools, pharmaceutical companies and drug development researchers and decision-makers.



Pharmaceutical Medicine And Translational Clinical Research


Pharmaceutical Medicine And Translational Clinical Research
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Author : Divya Vohora
language : en
Publisher: Academic Press
Release Date : 2017-11-14

Pharmaceutical Medicine And Translational Clinical Research written by Divya Vohora and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-11-14 with Medical categories.


Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features. As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery



Real World Evidence In Drug Development And Evaluation


Real World Evidence In Drug Development And Evaluation
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Author : Harry Yang
language : en
Publisher: CRC Press
Release Date : 2021-01-11

Real World Evidence In Drug Development And Evaluation written by Harry Yang and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-01-11 with Mathematics categories.


Real-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field. Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions. Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outcomes- and value-based RWE assessments Demonstrates proper Bayesian application and causal inference for real-world data (RWD) Presents real-world use cases to illustrate the use of advanced analytics and statistical methods to generate insights Offers a balanced discussion of practical RWE issues at hand and technical solutions suitable for practitioners with limited data science expertise



Building A National Framework For The Establishment Of Regulatory Science For Drug Development


Building A National Framework For The Establishment Of Regulatory Science For Drug Development
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-03-15

Building A National Framework For The Establishment Of Regulatory Science For Drug Development written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-03-15 with Medical categories.


The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.



Breakthrough Business Models


Breakthrough Business Models
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2009-02-17

Breakthrough Business Models written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009-02-17 with Medical categories.


The process for developing new drug and biologic products is extraordinarily expensive and time-consuming. Although large pharmaceutical companies may be able to afford the cost of development because they can expect a large return on investment, organizations developing drugs to treat rare and neglected diseases are unable to rely on such returns. On June 23, 2008, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held a public workshop, "Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies," which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.



Peptide Drug Discovery And Development


Peptide Drug Discovery And Development
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Author : Miguel Castanho
language : en
Publisher: John Wiley & Sons
Release Date : 2011-10-24

Peptide Drug Discovery And Development written by Miguel Castanho and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-10-24 with Medical categories.


Filling a real knowledge gap, this handbook and ready reference is both modern and forward-looking in its emphasis on the "bench to bedside" translational approach to drug development. Clearly structured into three major parts, the book stakes out the boundaries of peptide drug development in the preclinical as well as clinical stages. The first part provides a general background and focuses on the characteristic strengths and weaknesses of peptide drugs. The second section contains five cases studies of peptides from diverse therapeutic fields, and the lessons to be learned from them, while the final part looks at new targets and opportunities, discussing several drug targets and diseases for which peptide drugs are currently being developed.



Translational Studies On Inflammation


Translational Studies On Inflammation
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Author : Ane C.F. Nunes
language : en
Publisher:
Release Date : 2020

Translational Studies On Inflammation written by Ane C.F. Nunes and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020 with categories.


Inflammation is known worldwide, from the bench to the bedside, but it is a hard theme to approach with one single point of view.In this sense, a selection of translational studies would support the medical-scientific community to better understand the complex network of the inflammatory process, its maintenance, and potential treatment targets. The eleven chapters that compose this book present interesting insights into inflammation and its mechanisms, merging classic background with innovative approaches. From the molecular basis to experimental models, the chapters selected for this book bring to readers at different academic levels updated and practical data on inflammation. Find out what drives interdisciplinary medical research on inflammation and enjoy this informative collection.



Translational Medicine In Cns Drug Development


Translational Medicine In Cns Drug Development
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Author : George G. Nomikos
language : en
Publisher: Academic Press
Release Date : 2019-06-19

Translational Medicine In Cns Drug Development written by George G. Nomikos and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-06-19 with Medical categories.


Translational Medicine in CNS Drug Development, Volume 29, is the first book of its kind to offer a comprehensive overview of the latest developments in translational medicine and biomarker techniques. With extensive coverage on all aspects of biomarkers and personalized medicine, and numerous chapters devoted to the best strategies for developing drugs that target specific disorders, this book presents an essential reference for researchers in neuroscience and pharmacology who need the most up-to-date techniques for the successful development of drugs to treat central nervous system disorders. Despite increases in the number of individuals suffering from CNS-related disorders, the development and approval of drugs for their treatment have been hampered by inefficiencies in advancing compounds from preclinical discovery to the clinic. However, in the past decades, game-changing strides have been made in our understanding of the pathophysiology of CNS disorders and the relationship of drug exposure in plasma and CNS to pharmacodynamic measures in both animals and humans.



Animal And Translational Models For Cns Drug Discovery Neurological Disorders


Animal And Translational Models For Cns Drug Discovery Neurological Disorders
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Author : Robert A. McArthur
language : en
Publisher: Academic Press
Release Date : 2008-11-18

Animal And Translational Models For Cns Drug Discovery Neurological Disorders written by Robert A. McArthur and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-11-18 with Medical categories.


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