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Innovative Pharmacometric Approaches To Inform Drug Development And Clinical Use
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Book Synopsis Innovative Pharmacometric Approaches to Inform Drug Development and Clinical Use by : Zinnia P. Parra-Guillen
Download or read book Innovative Pharmacometric Approaches to Inform Drug Development and Clinical Use written by Zinnia P. Parra-Guillen and published by Frontiers Media SA. This book was released on 2024-02-21 with total page 117 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacometrics represents a strategy to optimize and rationalize decision-making process integrating information on drug behavior, pharmacological response, and disease progression both in the drug development phases and in their clinical use. Pharmacometrics focuses on characterizing the pharmacokinetic and pharmacodynamic behavior of one or several active ingredients through the development of mathematical and statistical models that allow characterizing both the average behavior in the population and the different sources of variability. Currently, pharmacometrics has transformed drug development and therapeutic use paradigm, which yield to the recognition by the main regulatory agencies (FDA, EMA, and PMDA).
Book Synopsis Translational Biomedical Informatics by : Bairong Shen
Download or read book Translational Biomedical Informatics written by Bairong Shen and published by Springer. This book was released on 2016-10-31 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces readers to essential methods and applications in translational biomedical informatics, which include biomedical big data, cloud computing and algorithms for understanding omics data, imaging data, electronic health records and public health data. The storage, retrieval, mining and knowledge discovery of biomedical big data will be among the key challenges for future translational research. The paradigm for precision medicine and healthcare needs to integratively analyze not only the data at the same level – e.g. different omics data at the molecular level – but also data from different levels – the molecular, cellular, tissue, clinical and public health level. This book discusses the following major aspects: the structure of cross-level data; clinical patient information and its shareability; and standardization and privacy. It offers a valuable guide for all biologists, biomedical informaticians and clinicians with an interest in Precision Medicine Informatics.
Book Synopsis Principles and Practice of Clinical Trials by : Steven Piantadosi
Download or read book Principles and Practice of Clinical Trials written by Steven Piantadosi and published by Springer Nature. This book was released on 2022-07-19 with total page 2573 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time. Principles in Practice of Clinical Trials is truly an interdisciplinary that will be divided into the following areas: 1) Clinical Trials Basic Perspectives 2) Regulation and Oversight 3) Basic Trial Designs 4) Advanced Trial Designs 5) Analysis 6) Trial Publication 7) Topics Related Specific Populations and Legal Aspects of Clinical Trials The Work is designed to be comprised of 175 chapters and approximately 2500 pages. The Work will be oriented like many of our SpringerReference Handbooks, presenting detailed and comprehensive expository chapters on broad subjects. The Editors are major figures in the field of clinical trials, and both have written textbooks on the topic. There will also be a slate of 7-8 renowned associate editors that will edit individual sections of the Reference.
Download or read book Pharmacometrics written by Ene I. Ette and published by John Wiley & Sons. This book was released on 2013-03-14 with total page 1236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmacometrics is the science of interpreting and describing pharmacology in a quantitative fashion. The pharmaceutical industry is integrating pharmacometrics into its drug development program, but there is a lack of and need for experienced pharmacometricians since fewer and fewer academic programs exist to train them. Pharmacometrics: The Science of Quantitative Pharmacology lays out the science of pharmacometrics and its application to drug development, evaluation, and patient pharmacotherapy, providing a comprehensive set of tools for the training and development of pharmacometricians. Edited and written by key leaders in the field, this flagship text on pharmacometrics: Integrates theory and practice to let the reader apply principles and concepts. Provides a comprehensive set of tools for training and developing expertise in the pharmacometric field. Is unique in including computer code information with the examples. This volume is an invaluable resource for all pharmacometricians, statisticians, teachers, graduate and undergraduate students in academia, industry, and regulatory agencies.
Book Synopsis Translational Medicine and Drug Discovery by : Bruce H. Littman
Download or read book Translational Medicine and Drug Discovery written by Bruce H. Littman and published by Cambridge University Press. This book was released on 2011-01-31 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition by : Johan Gabrielsson
Download or read book Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition written by Johan Gabrielsson and published by CRC Press. This book was released on 2001-11-30 with total page 926 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a revised and very expanded version of the previous second edition of the book. "Pharmacokinetic and Pharmacodynamic Data Analysis" provides an introduction into pharmacokinetic and pharmacodynamic concepts using simple illustrations and reasoning. It describes ways in which pharmacodynamic and pharmacodynamic theory may be used to give insight into modeling questions and how these questions can in turn lead to new knowledge. This book differentiates itself from other texts in this area in that it bridges the gap between relevant theory and the actual application of the theory to real life situations. The book is divided into two parts; the first introduces fundamental principles of PK and PD concepts, and principles of mathematical modeling, while the second provides case studies obtained from drug industry and academia. Topics included in the first part include a discussion of the statistical principles of model fitting, including how to assess the adequacy of the fit of a model, as well as strategies for selection of time points to be included in the design of a study. The first part also introduces basic pharmacokinetic and pharmacodynamic concepts, including an excellent discussion of effect compartment (link) models as well as indirect response models. The second part of the text includes over 70 modeling case studies. These include a discussion of the selection of the model, derivation of initial parameter estimates and interpretation of the corresponding output. Finally, the authors discuss a number of pharmacodynamic modeling situations including receptor binding models, synergy, and tolerance models (feedback and precursor models). This book will be of interest to researchers, to graduate students and advanced undergraduate students in the PK/PD area who wish to learn how to analyze biological data and build models and to become familiar with new areas of application. In addition, the text will be of interest to toxicologists interested in learning about determinants of exposure and performing toxicokinetic modeling. The inclusion of the numerous exercises and models makes it an excellent primary or adjutant text for traditional PK courses taught in pharmacy and medical schools. A diskette is included with the text that includes all of the exercises and solutions using WinNonlin.
Download or read book It's Alive written by Chris Meyer and published by Crown Currency. This book was released on 2003-05-13 with total page 275 pages. Available in PDF, EPUB and Kindle. Book excerpt: Why we are on the cusp of a new economic era that will make the changes and challenges of the Information Era seem like child’s play From the bestselling authors of Blur—a defining book of the Information Age—comes a startling glimpse into the near future and the emerging economy that awaits us. It’s Alive foretells the jolt the world is about to receive as the science of molecular evolution races out of the laboratories and into the business world. Think back to the early 1970s. Imagine the opportunities for your business, career choice, and investments had you received an advance report on the ways in which computer and information technology would revolutionize the world. It’s Alive provides that opportunity today: a realistic and persuasive look into the future—the molecular economy—and how it is starting to overtake and reshape the Information Age. Today’s gene mapping and molecular engineering are equivalent to the introduction of transistor radios at the advent of the information economy. Solid-state technology moved from the labs into the business arena, providing in turn the transistor, the microprocessor, and the modem—and the information business. During the next ten years, molecular technology will follow the same pattern, moving from the lab and into the basic operation of the corporation itself. Chris Meyer and Stan Davis are our guides in understanding this new future. They show that not only biological systems evolve. The rules of evolution help explain the process of change in biology, business, and the economy, thereby providing a management guide to the business world around the corner. It’s Alive is not science fiction or futurism. It bases its insights and predictions on the impact the molecular economy is already having in such diverse business environments as manufacturing, financial services, and energy. Through in-depth case studies of Capital One Financial, the U.S. Marine Corps, British Petroleum, and the biotech firm Maxygen, Meyer and Davis show how adaptive behavior works in the real world. As the rules of evolution combine with the connected economy, our business world will become unpredictable, volatile, and continually adaptive—in other words, alive. Also available as an eBook.
Book Synopsis Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications by : Hartmut Derendorf
Download or read book Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications written by Hartmut Derendorf and published by Lippincott Williams & Wilkins. This book was released on 2019-07-11 with total page 1334 pages. Available in PDF, EPUB and Kindle. Book excerpt: Updated with the latest clinical advances, Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics, Fifth Edition , explains the relationship between drug administration and drug response, taking a conceptual approach that emphasizes clinical application rather than science and mathematics. Bringing a real-life perspective to the topic, the book simplifies concepts and gives readers the knowledge they need to better evaluate drug applications.
Book Synopsis Applied Pharmacometrics by : Stephan Schmidt
Download or read book Applied Pharmacometrics written by Stephan Schmidt and published by Springer. This book was released on 2014-12-01 with total page 570 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive volume provides an update on the current state of pharmacometrics in drug development. It consists of nineteen chapters all written by leading scientists from the pharmaceutical industry, regulatory agencies and academia. After an introduction of the basic pharmacokinetic and pharmacodynamic concepts of pharmacometrics in drug development, the book presents numerous examples of specific applications that utilize pharmacometrics with modeling and simulations over a variety of therapeutic areas, including pediatrics, diabetes, obesity, infections, psychiatrics, Alzheimer’s disease, and dermatology, among others. The examples illustrate how results from all phases of drug development can be integrated in a more timely and cost-effective process. Applying pharmacometric decision tools during drug development can allow objective, data-based decision making. At the same time, the process can identify redundant or unnecessary experiments as well as some costly clinical trials that can be avoided. In addition to cost saving by expedited development of successful drug candidates, pharmacometrics has an important economic impact in drug product selection. Unsuccessful drug candidates can be identified early and discontinued without expending efforts required for additional studies and allocating limited resources. Hence, pharmacometric modeling and simulation has become a powerful tool to bring new and better medications to the patient at a faster pace and with greater probability of success.
Book Synopsis Mixed Effects Models for the Population Approach by : Marc Lavielle
Download or read book Mixed Effects Models for the Population Approach written by Marc Lavielle and published by CRC Press. This book was released on 2014-07-14 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt: Wide-Ranging Coverage of Parametric Modeling in Linear and Nonlinear Mixed Effects ModelsMixed Effects Models for the Population Approach: Models, Tasks, Methods and Tools presents a rigorous framework for describing, implementing, and using mixed effects models. With these models, readers can perform parameter estimation and modeling across a whol
Book Synopsis The Learning Healthcare System by : Institute of Medicine
Download or read book The Learning Healthcare System written by Institute of Medicine and published by National Academies Press. This book was released on 2007-06-01 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: As our nation enters a new era of medical science that offers the real prospect of personalized health care, we will be confronted by an increasingly complex array of health care options and decisions. The Learning Healthcare System considers how health care is structured to develop and to apply evidence-from health profession training and infrastructure development to advances in research methodology, patient engagement, payment schemes, and measurement-and highlights opportunities for the creation of a sustainable learning health care system that gets the right care to people when they need it and then captures the results for improvement. This book will be of primary interest to hospital and insurance industry administrators, health care providers, those who train and educate health workers, researchers, and policymakers. The Learning Healthcare System is the first in a series that will focus on issues important to improving the development and application of evidence in health care decision making. The Roundtable on Evidence-Based Medicine serves as a neutral venue for cooperative work among key stakeholders on several dimensions: to help transform the availability and use of the best evidence for the collaborative health care choices of each patient and provider; to drive the process of discovery as a natural outgrowth of patient care; and, ultimately, to ensure innovation, quality, safety, and value in health care.
Book Synopsis Developing Drug Products in an Aging Society by : Sven Stegemann
Download or read book Developing Drug Products in an Aging Society written by Sven Stegemann and published by Springer. This book was released on 2016-10-20 with total page 764 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book aims to address the major aspects of future drug product development and therapy for older adults, giving practical guidance for the rational product and clinical development and prescribing of drug products to this ever growing segment of the population. With authors coming from key “aging” markets such as Europe, the USA, China and Japan, the book will provide valuable information for students, scientists, regulators, practitioners, and other healthcare professionals from academia, industry and regulatory bodies.
Book Synopsis Translational Medicine in CNS Drug Development by : George G. Nomikos
Download or read book Translational Medicine in CNS Drug Development written by George G. Nomikos and published by Academic Press. This book was released on 2019-06-18 with total page 460 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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. - Includes comprehensive coverage of biomarker tools and the role of personalized medicine in CNS drug development - Discusses strategies for drug development for a full range of CNS indications, with particular attention to neuropsychiatric and neurocognitive disorders - Includes chapters written by international experts from industry and academia
Book Synopsis Basic Pharmacokinetics by : Mohsen A. Hedaya
Download or read book Basic Pharmacokinetics written by Mohsen A. Hedaya and published by Taylor & Francis. This book was released on 2023-09-13 with total page 464 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces basic pharmacokinetic concepts to beginner learners to help them understand the absorption, distribution, metabolism, and excretion of drugs. After a basic introduction to pharmacokinetics and its related fields, the book provides a clear introduction to quantitative pharmacokinetic relations and the interplay between pharmacokinetic parameters after different routes of drug administration. Emphasizing the application and importance of pharmacokinetic concepts in clinical practice throughout, the book features: A clear, simple, and concise style with the use of graphs and simulations to aid learning. Bullet point summaries of each concept to demonstrate applications in clinical practice. Practice problems and solved examples to help the reader understand the best approach for calculating pharmacokinetic parameters. A glossary of key words and acronyms. This book is an essential read for undergraduate and graduate pharmacokinetic students in pharmacy, pharmacology, and pharmaceutical science programs worldwide. Accompanying the book is a website with self-instructional tutorials and pharmacokinetic simulations, allowing visualization of concepts for enhanced comprehension. This learning tool received an award from the American Association of Colleges of Pharmacy for innovation in teaching, making it a valuable supplement to this textbook.
Book Synopsis Dose Finding in Drug Development by : Naitee Ting
Download or read book Dose Finding in Drug Development written by Naitee Ting and published by Springer Science & Business Media. This book was released on 2006-12-29 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: If you have ever wondered when visiting the pharmacy how the dosage of your prescription is determined this book will answer your questions. Dosing information on drug labels is based on discussion between the pharmaceutical manufacturer and the drug regulatory agency, and the label is a summary of results obtained from many scientific experiments. The book introduces the drug development process, the design and the analysis of clinical trials. Many of the discussions are based on applications of statistical methods in the design and analysis of dose response studies. Important procedural steps from a pharmaceutical industry perspective are also examined.
Book Synopsis Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations by : Sheila Annie Peters
Download or read book Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations written by Sheila Annie Peters and published by John Wiley & Sons. This book was released on 2021-09-30 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt: Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations The first book dedicated to the emerging field of physiologically based pharmacokinetic modeling (PBPK) Now in its second edition, Physiologically Based Pharmacokinetic (PBPK) Modelling and Simulations: Principles, Methods, and Applications in the Pharma Industry remains the premier reference book throughout the rapidly growing PBPK user community. Using clear and concise language, author Sheila Annie Peters connects theory with practice as she explores the vast potential of PBPK modeling for improving drug discovery and development. This fully updated new edition covers key developments in the field of PBPK modelling and simulations that have emerged in recent years. A brand-new section provides case studies in different application areas of PBPK modelling, including drug-drug interaction, genetic polymorphism, renal impairment, and pediatric extrapolation. Additional chapters address topics such as model-informed drug development (MIDD) and expose readers to a wide range of current applications in the field. Throughout the book, substantially revised chapters simplify complex topics and offer a balanced view of both the opportunities and challenges of PBPK modelling. Providing timely and comprehensive coverage of one of the most exciting new areas of pharmaceutical science, this book: Describes the principles behind physiological modeling of pharmacokinetic processes, inter-individual variability, and drug interactions for small molecule drugs and biologics Features a wealth of new figures and case studies of the applications of PBPK modelling along the value chain in drug discovery and development Reflects the latest regulatory guidelines on the reporting of PBPK modelling analysis Includes access to a new companion website containing code, datasets, explanations of case examples in the text, and discussion of key developments in the field Contains a brief overview of the field, end-of-chapter keywords for easy reference, and an extensive bibliography Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry, Second Edition is an indispensable single-volume resource for beginning and intermediate practitioners across the pharmaceutical sciences in both industry and academia.
Book Synopsis Imaging for Clinical Oncology by : Peter Hoskin
Download or read book Imaging for Clinical Oncology written by Peter Hoskin and published by Oxford University Press. This book was released on 2021 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: Imaging is a critical component of the management of patients having radiotherapy. This book covers the basic principles of the main imaging modalities; site specific chapters give best practice for individual tumour sites, and it also contains information on radioprotection and regulatory issues.
