Pharmaceutical Medicine And Translational Clinical Research

✏Book Title : Pharmaceutical Medicine and Translational Clinical Research
✏Author : Divya Vohora
✏Publisher : Academic Press
✏Release Date : 2017-11-14
✏Pages : 526
✏ISBN : 9780128020982
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Pharmaceutical Medicine and Translational Clinical Research Book Summary : 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

✏Book Title : Pharmaceutical Drug Product Development and Process Optimization
✏Author : Sarwar Beg
✏Publisher : CRC Press
✏Release Date : 2020-05-01
✏Pages : 354
✏ISBN : 9781000731583
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Pharmaceutical Drug Product Development and Process Optimization Book Summary : Pharmaceutical manufacturers are constantly facing quality crises of drug products, leading to an escalating number of product recalls and rejects. Due to the involvement of multiple factors, the goal of achieving consistent product quality is always a great challenge for pharmaceutical scientists. This volume addresses this challenge by using the Quality by Design (QbD) concept, which was instituted to focus on the systematic development of drug products with predefined objectives to provide enhanced product and process understanding. This volume presents and discusses the vital precepts underlying the efficient, effective, and cost effective development of pharmaceutical drug products. It focuses on the adoption of systematic quality principles of pharmaceutical development, which is imperative in achieving continuous improvement in end-product quality and also leads to reducing cost, time, and effort, while meeting regulatory requirements. The volume covers the important new advances in the development of solid oral dosage forms, modified release oral dosage forms, parenteral dosage forms, semisolid dosage forms, transdermal drug, delivery systems, inhalational dosage forms, ocular drug delivery systems, nanopharmaceutical products, and nanoparticles for oral delivery.

✏Book Title : Translational and Experimental Clinical Research
✏Author : Daniel P. Schuster
✏Publisher : Lippincott Williams & Wilkins
✏Release Date : 2005
✏Pages : 490
✏ISBN : 0781755654
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational and Experimental Clinical Research Book Summary : This volume is a comprehensive textbook for investigators entering the rapidly growing field of translational and experimental clinical research. The book offers detailed guidelines for designing and conducting a study and analyzing and reporting results and discusses key ethical and regulatory issues. Chapters address specific types of studies such as clinical experiments in small numbers of patients, pharmacokinetics and pharmacodynamics, and gene therapy and pharmacogenomic studies. A major section describes modern techniques of translational clinical research, including gene expression, identifying mutations and polymorphisms, cloning, transcriptional profiling, proteomics, cell and tissue imaging, tissue banking, evaluating substrate metabolism, and in vivo imaging.

✏Book Title : Drug Discovery and Development
✏Author : Vishwanath Gaitonde
✏Publisher : BoD – Books on Demand
✏Release Date : 2020-03-11
✏Pages : 164
✏ISBN : 9781789239751
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Drug Discovery and Development Book Summary : The process of drug discovery and development is a complex multistage logistics project spanned over 10-15 years with an average budget exceeding 1 billion USD. Starting with target identification and synthesizing anywhere between 10k to 15k synthetic compounds to potentially obtain the final drug that reaches the market involves a complicated maze with multiple inter- and intra-operative fields. Topics described in this book emphasize the progresses in computational applications, pharmacokinetics advances, and molecular modeling developments. In addition the book also contains special topics describing target deorphaning in Mycobacterium tuberculosis, therapy treatment of some rare diseases, and developments in the pediatric drug discovery process.

✏Book Title : Global Innovation Index 2019 Creating Healthy Lives The Future of Medical Innovation
✏Author : World Intellectual Property Organization
✏Publisher : WIPO
✏Release Date : 2019-07-24
✏Pages : 450
✏ISBN : 9791095870142
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Global Innovation Index 2019 Creating Healthy Lives The Future of Medical Innovation Book Summary : The Global Innovation Index 2019 provides detailed metrics about the innovation performance of 129 countries and economies around the world. Its 80 indicators explore a broad vision of innovation, including political environment, education, infrastructure and business sophistication. The GII 2019 analyzes the medical innovation landscape of the next decade, looking at how technological and non-technological medical innovation will transform the delivery of healthcare worldwide. It also explores the role and dynamics of medical innovation as it shapes the future of healthcare, and the potential influence this may have on economic growth. Chapters of the report provide more details on this year’s theme from academic, business, and particular country perspectives from leading experts and decision makers.

✏Book Title : Proceedings of 12th International Conference and Exhibition on Pharmacovigilance Drug Safety 2018
✏Author : ConferenceSeries
✏Publisher : ConferenceSeries
✏Release Date :
✏Pages : 83
✏ISBN :
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Proceedings of 12th International Conference and Exhibition on Pharmacovigilance Drug Safety 2018 Book Summary : June 21-22, 2018 Rome, Italy Key Topics : Pre-Clinical and Clinical Trials, Adverse Drug Reactions, Pharmacovigilance and Risk Management, Good Pharmacovigilance Practice, Pharmacy Practices and its Challenges, Biopharmaceutical Sciences, Clinical Trials on Various Disorders, Data Quality Management and Analysis, Pharmacovigilance Significance & Scope, Diversity in Industrial Clinical Trials and Clinical Research, Clinical Research and Statistics, Case Report in Clinical Trials, Drug Safety, Clinical Data Base Management, PV Consultings and Business Opportunity, Regulatory Affairs, Entrepreneurs Investment Meet,

✏Book Title : Transforming Clinical Research in the United States
✏Author : Institute of Medicine
✏Publisher : National Academies Press
✏Release Date : 2010-10-22
✏Pages : 150
✏ISBN : 0309163358
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Transforming Clinical Research in the United States Book Summary : An ideal health care system relies on efficiently generating timely, accurate evidence to deliver on its promise of diminishing the divide between clinical practice and research. There are growing indications, however, that the current health care system and the clinical research that guides medical decisions in the United States falls far short of this vision. The process of generating medical evidence through clinical trials in the United States is expensive and lengthy, includes a number of regulatory hurdles, and is based on a limited infrastructure. The link between clinical research and medical progress is also frequently misunderstood or unsupported by both patients and providers. The focus of clinical research changes as diseases emerge and new treatments create cures for old conditions. As diseases evolve, the ultimate goal remains to speed new and improved medical treatments to patients throughout the world. To keep pace with rapidly changing health care demands, clinical research resources need to be organized and on hand to address the numerous health care questions that continually emerge. Improving the overall capacity of the clinical research enterprise will depend on ensuring that there is an adequate infrastructure in place to support the investigators who conduct research, the patients with real diseases who volunteer to participate in experimental research, and the institutions that organize and carry out the trials. To address these issues and better understand the current state of clinical research in the United States, the Institute of Medicine's (IOM) Forum on Drug Discovery, Development, and Translation held a 2-day workshop entitled Transforming Clinical Research in the United States. The workshop, summarized in this volume, laid the foundation for a broader initiative of the Forum addressing different aspects of clinical research. Future Forum plans include further examining regulatory, administrative, and structural barriers to the effective conduct of clinical research; developing a vision for a stable, continuously funded clinical research infrastructure in the United States; and considering strategies and collaborative activities to facilitate more robust public engagement in the clinical research enterprise.

✏Book Title : Animal and Translational Models for CNS Drug Discovery Reward Deficit Disorders
✏Author : Robert A. McArthur
✏Publisher : Academic Press
✏Release Date : 2009-02-24
✏Pages : 432
✏ISBN : 9780080920405
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Animal and Translational Models for CNS Drug Discovery Reward Deficit Disorders Book Summary : Reward Deficit Disorders is written for researchers in both academia and the pharmaceutical industry who use animal models in research and development of drugs for reward deficit disorders such as alcohol dependence, nicotine dependence, heroin and cocaine addiction, obesity, and gambling and impulse control disorders. Reward Deficit 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. Reward Deficit Disorders also has a section dedicated to the specifics of the regulatory aspects to abuse liability testing. 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 third 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. Provides 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 Emphasizes what results mean to the overall drug discovery process Explores issues in clinical trial design and conductance in each therapeutic area Neurological Disorders is available for purchase individually.

✏Book Title : Translational Medicine
✏Author : Robert A. Meyers
✏Publisher : John Wiley & Sons
✏Release Date : 2018-07-16
✏Pages : 1064
✏ISBN : 9783527336593
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational Medicine Book Summary : This reference work gives a compete overview of the different stages of drug development using a translational approach. The book is structured in different parts, following the different stages in drug development. Almost half of the work is dedicated to core of drug discovery using a translational approach, the identification of appropriate targets and screening methods for the identification of compounds interacting with these targets. The rest of book covers the whole downstream pipeline after the identification of lead compounds, such as bioavailability issues, identification of appropriate drug delivery venues, production and scaling issues and preclinical trials. As has been the case with other works in the encyclopedia, the book is made up of long, comprehensive and authoritative chapters, written by outstanding researchers in the field.

✏Book Title : Design and Analysis of Clinical Trials
✏Author : Shein-Chung Chow
✏Publisher : John Wiley & Sons
✏Release Date : 2013-09-30
✏Pages : 892
✏ISBN : 9781118458143
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Design and Analysis of Clinical Trials Book Summary : Praise for the Second Edition: “...a grand feast for biostatisticians. It stands readyto satisfy the appetite of any pharmaceutical scientist with arespectable statistical appetite.” —Journal of ClinicalResearch Best Practices The Third Edition of Design and Analysis of ClinicalTrials provides complete, comprehensive, and expanded coverageof recent health treatments and interventions. Featuring a unifiedpresentation, the book provides a well-balanced summary of currentregulatory requirements and recently developed statistical methodsas well as an overview of the various designs and analyses that areutilized at different stages of clinical research and development.Additional features of this Third Edition include: • New chapters on biomarker development and targetclinical trials, adaptive design, trials for evaluating diagnosticdevices, statistical methods for translational medicine, andtraditional Chinese medicine • A balanced overview of current and emerging clinicalissues as well as newly developed statistical methodologies • Practical examples of clinical trials that demonstrateeveryday applicability, with illustrations and examples to explainkey concepts • New sections on bridging studies and global trials, QTstudies, multinational trials, comparative effectiveness trials,and the analysis of QT/QTc prolongation • A complete and balanced presentation of clinical andscientific issues, statistical concepts, and methodologies forbridging clinical and statistical disciplines • An update of each chapter that reflects changes inregulatory requirements for the drug review and approval processand recent developments in statistical design and methodology forclinical research and development Design and Analysis of Clinical Trials, Third Editioncontinues to be an ideal clinical research reference for academic,pharmaceutical, medical, and regulatory scientists/researchers,statisticians, and graduate-level students.

✏Book Title : Translational Medicine
✏Author : Dennis Cosmatos
✏Publisher : CRC Press
✏Release Date : 2008-12-17
✏Pages : 224
✏ISBN : 1584888733
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational Medicine Book Summary : Examines Critical Decisions for Transitioning Lab Science to a Clinical Setting The development of therapeutic pharmaceutical compounds is becoming more expensive, and the success rates for getting such treatments approved for marketing and to the patients is decreasing. As a result, translational medicine (TM) is becoming increasingly important in the healthcare industry – a means of maximizing the consideration and use of information collected as compounds transition from initial lab discovery, through pre-clinical testing, early clinical trials, and late confirmatory studies that lead to regulatory approval of drug release to patients. Translational Medicine: Strategies and Statistical Methods suggests a process for transitioning from the initial lab discovery to the patient’s bedside with minimal disconnect and offers a comprehensive review of statistical design and methodology commonly employed in this bench-to-bedside research. Documents Alternative Research Approaches for Faster and More Accurate Data Judgment Calls Elaborating on how to introduce TM into clinical studies, this authoritative work presents a keen approach to building, executing, and validating statistical models that consider data from various phases of development. It also delineates a truly translational example to help bolster understanding of discussed concepts. This comprehensive guide effectively demonstrates how to overcome obstacles related to successful TM practice. It contains invaluable information for pharmaceutical scientists, research executives, clinicians, and biostatisticians looking to expedite successful implementation of this important process.

✏Book Title : Sharing Clinical Research Data
✏Author : Institute of Medicine
✏Publisher : National Academies Press
✏Release Date : 2013-06-07
✏Pages : 156
✏ISBN : 9780309268745
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Sharing Clinical Research Data Book Summary : Pharmaceutical companies, academic researchers, and government agencies such as the Food and Drug Administration and the National Institutes of Health all possess large quantities of clinical research data. If these data were shared more widely within and across sectors, the resulting research advances derived from data pooling and analysis could improve public health, enhance patient safety, and spur drug development. Data sharing can also increase public trust in clinical trials and conclusions derived from them by lending transparency to the clinical research process. Much of this information, however, is never shared. Retention of clinical research data by investigators and within organizations may represent lost opportunities in biomedical research. Despite the potential benefits that could be accrued from pooling and analysis of shared data, barriers to data sharing faced by researchers in industry include concerns about data mining, erroneous secondary analyses of data, and unwarranted litigation, as well as a desire to protect confidential commercial information. Academic partners face significant cultural barriers to sharing data and participating in longer term collaborative efforts that stem from a desire to protect intellectual autonomy and a career advancement system built on priority of publication and citation requirements. Some barriers, like the need to protect patient privacy, pre- sent challenges for both sectors. Looking ahead, there are also a number of technical challenges to be faced in analyzing potentially large and heterogeneous datasets. This public workshop focused on strategies to facilitate sharing of clinical research data in order to advance scientific knowledge and public health. While the workshop focused on sharing of data from preplanned interventional studies of human subjects, models and projects involving sharing of other clinical data types were considered to the extent that they provided lessons learned and best practices. The workshop objectives were to examine the benefits of sharing of clinical research data from all sectors and among these sectors, including, for example: benefits to the research and development enterprise and benefits to the analysis of safety and efficacy. Sharing Clinical Research Data: Workshop Summary identifies barriers and challenges to sharing clinical research data, explores strategies to address these barriers and challenges, including identifying priority actions and "low-hanging fruit" opportunities, and discusses strategies for using these potentially large datasets to facilitate scientific and public health advances.

✏Book Title : Virtual Clinical Trials
✏Author : National Academies of Sciences, Engineering, and Medicine
✏Publisher : National Academies Press
✏Release Date : 2019-11-16
✏Pages : 126
✏ISBN : 9780309494885
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Virtual Clinical Trials Book Summary : Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice. On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

✏Book Title : Clinical and Translational Science
✏Author : David Robertson
✏Publisher : Academic Press
✏Release Date : 2016-11-25
✏Pages : 808
✏ISBN : 9780128021118
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Clinical and Translational Science Book Summary : Clinical and Translational Science: Principles of Human Research, Second Edition, is the most authoritative and timely resource for the broad range of investigators taking on the challenge of clinical and translational science, a field that is devoted to investigating human health and disease, interventions, and outcomes for the purposes of developing new treatment approaches, devices, and modalities to improve health. This updated second edition has been prepared with an international perspective, beginning with fundamental principles, experimental design, epidemiology, traditional and new biostatistical approaches, and investigative tools. It presents complete instruction and guidance from fundamental principles, approaches, and infrastructure, especially for human genetics and genomics, human pharmacology, research in special populations, the societal context of human research, and the future of human research. The book moves on to discuss legal, social, and ethical issues, and concludes with a discussion of future prospects, providing readers with a comprehensive view of this rapidly developing area of science. Introduces novel physiological and therapeutic strategies for engaging the fastest growing scientific field in both the private sector and academic medicine Brings insights from international leaders into the discipline of clinical and translational science Addresses drug discovery, drug repurposing and development, innovative and improved approaches to go/no-go decisions in drug development, and traditional and innovative clinical trial designs

✏Book Title : Clinical Research
✏Author : Robert D. Toto
✏Publisher : Lippincott Williams & Wilkins
✏Release Date : 2012-03-28
✏Pages : 256
✏ISBN : 9781451153354
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Clinical Research Book Summary : This book will serve as a road map for students and junior researchers seeking to successfully design, implement, and publish clinical research. It covers the basic elements of research proposals and implementation including regulatory approvals, continuing regulatory oversight, investigational new drug and device applications, monitoring patient safety, recruitment, clinical assessments, laboratory assessments, provision of treatment, and on-going quality control. The authors provide instruction on how to integrate research resources to successfully conduct a clinical research project, and offer guidelines on collection, quality control, and analysis of data. A companion website will include the fully searchable text and links to Journal of Investigative Medicine's "Research Tools and Issues" feature.

✏Book Title : Clinical Trial Methodology
✏Author : Karl E. Peace
✏Publisher : CRC Press
✏Release Date : 2010-07-20
✏Pages : 420
✏ISBN : 1584889187
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Clinical Trial Methodology Book Summary : Now viewed as its own scientific discipline, clinical trial methodology encompasses the methods required for the protection of participants in a clinical trial and the methods necessary to provide a valid inference about the objective of the trial. Drawing from the authors’ courses on the subject as well as the first author’s more than 30 years working in the pharmaceutical industry, Clinical Trial Methodology emphasizes the importance of statistical thinking in clinical research and presents the methodology as a key component of clinical research. From ethical issues and sample size considerations to adaptive design procedures and statistical analysis, the book first covers the methodology that spans every clinical trial regardless of the area of application. Crucial to the generic drug industry, bioequivalence clinical trials are then discussed. The authors describe a parallel bioequivalence clinical trial of six formulations incorporating group sequential procedures that permit sample size re-estimation. The final chapters incorporate real-world case studies of clinical trials from the authors’ own experiences. These examples include a landmark Phase III clinical trial involving the treatment of duodenal ulcers and Phase III clinical trials that contributed to the first drug approved for the treatment of Alzheimer’s disease. Aided by the U.S. FDA, the U.S. National Institutes of Health, the pharmaceutical industry, and academia, the area of clinical trial methodology has evolved over the last six decades into a scientific discipline. This guide explores the processes essential for developing and conducting a quality clinical trial protocol and providing quality data collection, biostatistical analyses, and a clinical study report, all while maintaining the highest standards of ethics and excellence.

✏Book Title : Flow Cytometry in Drug Discovery and Development
✏Author : Virginia Litwin
✏Publisher : John Wiley & Sons
✏Release Date : 2011-04-20
✏Pages : 360
✏ISBN : 9780470922781
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Flow Cytometry in Drug Discovery and Development Book Summary : This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.

✏Book Title : Biotechnology and Biopharmaceuticals
✏Author :
✏Publisher : John Wiley & Sons
✏Release Date : 2013-09-19
✏Pages : 744
✏ISBN : 9781118659984
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Biotechnology and Biopharmaceuticals Book Summary : Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

✏Book Title : Principles and Practice of Clinical Research
✏Author : John I. Gallin
✏Publisher : Academic Press
✏Release Date : 2012
✏Pages : 780
✏ISBN : 9780123821676
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Principles and Practice of Clinical Research Book Summary : This expanded third edition provides an introduction to the conduct of clinical research as well as more comprehensive and expansive content about the infrastructure necessary for a successful clinical research organization or enterprise. With authors who are experts in clinical research in both the public and private sectors, this publication provides essential information to clinical investigators who wish to develop and conduct well designed patient-based research protocols that comply with rigorous study design, ethical, and regulatory requirements.

✏Book Title : Translational Stroke Research
✏Author : Paul A. Lapchak
✏Publisher : Springer Science & Business Media
✏Release Date : 2012-03-22
✏Pages : 923
✏ISBN : 9781441995308
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational Stroke Research Book Summary : This volume sets a basis for effective translational research. Authored by experts in the field of translational stroke research, each chapter specifically addresses one or more components of preclinical stroke research. The emphasis is placed on target identification and drug development using state-of-the-art in vitro and in vivo assays, in combination with in vitro toxicology assays, AMDE and clinical design.

✏Book Title : Translational Medicine What Why and How
✏Author : Barbara Alving
✏Publisher : Karger Medical and Scientific Publishers
✏Release Date : 2012-12-01
✏Pages : 126
✏ISBN : 9783318022841
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational Medicine What Why and How Book Summary : This book is the first to provide an aerial view, as well as detailed information, on 'how' activities in translational medicine are under development in countries such as the USA, China, the UK, and Taiwan. Institutions in each country are training investigators to work as sophisticated interdisciplinary teams. Investigators from 11 US academic health centers explain how they are incentivizing collaborations through pilot project programs, forming partnerships with business schools to promote efficient management of basic and clinical research, creating ethical, high- value public-private (industry) partnerships, improving efficiency with utilization of informatics, and engaging the community in research. The essential role of evaluation is explained in a clear and concise manner. The readers will also learn about the role of private funding in Taiwan and the vision of the government in China in developing multiple translational research centers. The UK is developing methodical approaches to patient needs across their lifespans; ongoing innovation is encouraged through incubator programs. With the emphasis on open innovation and sharing, the concepts and practice of translational medicine are spreading rapidly on an international scale.

✏Book Title : Value Creation in the Pharmaceutical Industry
✏Author : Alexander Schuhmacher
✏Publisher : John Wiley & Sons
✏Release Date : 2016-04-11
✏Pages : 508
✏ISBN : 9783527339136
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Value Creation in the Pharmaceutical Industry Book Summary : This practical guide for advanced students and decision-makers in the pharma and biotech industry presents key success factors in R&D along with value creators in pharmaceutical innovation. A team of editors and authors with extensive experience in academia and industry and at some of the most prestigious business schools in Europe discusses in detail the innovation process in pharma as well as common and new research and innovation strategies. In doing so, they cover collaboration and partnerships, open innovation, biopharmaceuticals, translational medicine, good manufacturing practice, regulatory affairs, and portfolio management. Each chapter covers controversial aspects of recent developments in the pharmaceutical industry, with the aim of stimulating productive debates on the most effective and efficient innovation processes. A must-have for young professionals and MBA students preparing to enter R&D in pharma or biotech as well as for students on a combined BA/biomedical and natural sciences program.

✏Book Title : The SAGE Handbook of Healthcare
✏Author : Decision Resources Inc
✏Publisher : SAGE
✏Release Date : 2008-05-22
✏Pages : 752
✏ISBN : 9781847877000
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏The SAGE Handbook of Healthcare Book Summary : With escalating healthcare costs, changes to the regulatory control on pharmaceutical industries and the inevitable adjustments made in policies and investment in healthcare there is enormous interest in the commercial as well as the scientific aspects of today's healthcare industry. The SAGE Handbook of Healthcare provides an authoritative analysis of the current (and anticipated) developments in the global healthcare industries. Providing a unique perspective that interfaces between the science and business aspects, it combines information on the latest scientific developments with applied, commercial business data from the global marketplace. The Handbook focuses on the aspects of paramount importance in the healthcare sector: - Pharmacoeconomics - Pharmacogenomics - Therapeutics - Diagnostics Areas covered include: - The role of nanotechnology, genomics and cell therapy in medicine - Diagnostics; Biomarkers and technological advances - Case studies in oncology and cardiovascular and CNS therapeutics

✏Book Title : Translational Research Methods for Diabetes Obesity and Cardiometabolic Drug Development
✏Author : Andrew J. Krentz
✏Publisher : Springer
✏Release Date : 2014-11-29
✏Pages : 312
✏ISBN : 9781447149200
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational Research Methods for Diabetes Obesity and Cardiometabolic Drug Development Book Summary : The world is beset by a pandemic of obesity and type 2 diabetes and the need for new drugs is startlingly clear; recent years have seen a huge increase in research activity to fill this gap. The development of new drugs for diabetes and obesity must be founded upon a sound appreciation of the pathophysiology of these common disorders. The dual defects of insulin resistance and impaired insulin secretion are fundamental to the pathogenesis and progression of obesity-associated type 2 diabetes. There is a need to explain how new drugs can counter insulin resistance and insulin deficiency to a broad range of professionals, from clinical scientists active in early (and later) phase drug development to specialist physicians and increasingly primary care doctors who must tailor drug regimens to the individual patient. Clinical research methods for measuring insulin action and insulin secretion have become well-established in proof-of-mechanism studies; however, selection of the best techniques is by no means straightforward. The purpose of the book is to aid the selection of the most appropriate techniques for assessing insulin action, insulin secretion and body composition in humans (with particular reference to new drugs) in phase 1 and 2 studies and aid the understanding of drug effects and non-drug treatment strategies on key biochemical-hormonal defects of obesity and type 2 diabetes. The book will assume a working knowledge of human physiology relating to glucose metabolism and will be of interest to biomedical scientists, pharmacologists, academics involved in metabolic research and clinicians practicing in these specialties.

✏Book Title : Sequential Experimentation in Clinical Trials
✏Author : Jay Bartroff
✏Publisher : Springer Science & Business Media
✏Release Date : 2012-12-12
✏Pages : 240
✏ISBN : 9781461461142
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Sequential Experimentation in Clinical Trials Book Summary : Sequential Experimentation in Clinical Trials: Design and Analysis is developed from decades of work in research groups, statistical pedagogy, and workshop participation. Different parts of the book can be used for short courses on clinical trials, translational medical research, and sequential experimentation. The authors have successfully used the book to teach innovative clinical trial designs and statistical methods for Statistics Ph.D. students at Stanford University. There are additional online supplements for the book that include chapter-specific exercises and information. Sequential Experimentation in Clinical Trials: Design and Analysis covers the much broader subject of sequential experimentation that includes group sequential and adaptive designs of Phase II and III clinical trials, which have attracted much attention in the past three decades. In particular, the broad scope of design and analysis problems in sequential experimentation clearly requires a wide range of statistical methods and models from nonlinear regression analysis, experimental design, dynamic programming, survival analysis, resampling, and likelihood and Bayesian inference. The background material in these building blocks is summarized in Chapter 2 and Chapter 3 and certain sections in Chapter 6 and Chapter 7. Besides group sequential tests and adaptive designs, the book also introduces sequential change-point detection methods in Chapter 5 in connection with pharmacovigilance and public health surveillance. Together with dynamic programming and approximate dynamic programming in Chapter 3, the book therefore covers all basic topics for a graduate course in sequential analysis designs.

✏Book Title : Imaging in Drug Discovery and Early Clinical Trials
✏Author : Markus Rudin
✏Publisher : Springer Science & Business Media
✏Release Date : 2006-07-11
✏Pages : 392
✏ISBN : 3764377801
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Imaging in Drug Discovery and Early Clinical Trials Book Summary : This monograph examines the contribution of imaging modalities to the stages of drug discovery and development, from early target validation to their use in clinical development programs. Chapters are devoted to the description of the drug discovery process, to the various imaging modalities preclinically and clinically, to applications of imaging during the optimization of a lead compound, addressing issues such as bioavailability and efficacy, and during drug safety evaluation.

✏Book Title : Guide to Paediatric Drug Development and Clinical Research
✏Author : K. Rose
✏Publisher : Karger Medical and Scientific Publishers
✏Release Date : 2010-05-21
✏Pages : 242
✏ISBN : 9783805593632
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Guide to Paediatric Drug Development and Clinical Research Book Summary : Children in the developed world have never enjoyed better medical care: mortality has decreased and many fatal diseases of the past can today be prevented or even cured. However, the current practice of pharmacotherapy in children does not reflect existing scientific knowledge and has come under scrutiny by paediatricians, pharmacists and regulatory authorities. In order to advance the development of medicines tailored to paediatric needs, US and EU legislators have taken action, and the WHO has initiated a global paediatric campaign. This book gives an overview over the worldwide activities that increasingly include children in the development of new medicines. Triggered by both a better understanding of how the child’s body develops as well as recent legislation in the USA and in Europe, this comprises dosing, ethics, age-appropriate pharmaceutical forms and clinical trials, to name just a few aspects. A wide spectrum of readers will profit from this book, including paediatricians, pharmacists, general practitioners and health care professionals involved in child care and paediatric research, clinical trial personnel, patient advocacy groups, ethics committees, politicians, parents and interested lay persons.

✏Book Title : Public Engagement and Clinical Trials New Models and Disruptive Technologies
✏Author : Forum on Drug Discovery, Development, and Translation
✏Publisher : National Academies Press
✏Release Date : 2012-03-02
✏Pages : 121
✏ISBN : 9780309219303
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Public Engagement and Clinical Trials New Models and Disruptive Technologies Book Summary : Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.

✏Book Title : Translational Neuroscience
✏Author : James E. Barrett
✏Publisher : Cambridge University Press
✏Release Date : 2012-06-28
✏Pages :
✏ISBN : 9781139510301
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Translational Neuroscience Book Summary : Translational neuroscience is at the heart of clinical advancement in the fields of psychiatry, neurology and neurodevelopmental disorders. Written and edited by leading scientists and clinicians, this is a comprehensive and authoritative analysis of this emerging strategy for developing more effective treatments for brain disorders. Introductory chapters bring together perspectives from both academia and industry, while subsequent sections focus on disease groups, including bipolar disorder and depression, attention deficit hyperactivity disorder, substance abuse, autism, Alzheimer's disease, pain, epilepsy, Parkinson's disease and multiple sclerosis. Each section includes topical introductory and summary chapters, providing an overview and synthesis of the field. Translational Neuroscience: Applications in Psychiatry, Neurology, and Neurodevelopmental Disorders is an important text for clinicians, scientists and students in academic settings, government agencies and industry, as well as those working in the fields of public health and the behavioural sciences.

✏Book Title : Envisioning a Transformed Clinical Trials Enterprise in the United States
✏Author : Institute of Medicine
✏Publisher : National Academies Press
✏Release Date : 2012-10-13
✏Pages : 248
✏ISBN : 9780309253154
✏Available Language : English, Spanish, And French

---

Click Here To Get Book

✏Envisioning a Transformed Clinical Trials Enterprise in the United States Book Summary : There is growing recognition that the United States' clinical trials enterprise (CTE) faces great challenges. There is a gap between what is desired - where medical care is provided solely based on high quality evidence - and the reality - where there is limited capacity to generate timely and practical evidence for drug development and to support medical treatment decisions. With the need for transforming the CTE in the U.S. becoming more pressing, the IOM Forum on Drug Discovery, Development, and Translation held a two-day workshop in November 2011, bringing together leaders in research and health care. The workshop focused on how to transform the CTE and discussed a vision to make the enterprise more efficient, effective, and fully integrated into the health care system. Key issue areas addressed at the workshop included: the development of a robust clinical trials workforce, the alignment of cultural and financial incentives for clinical trials, and the creation of a sustainable infrastructure to support a transformed CTE. This document summarizes the workshop.