Innovative Pharmacometric Approaches To Inform Drug Development And Clinical Use
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| Author | : Zinnia P. Parra-Guillen |
| Publisher | : Frontiers Media SA |
| Total Pages | : 117 |
| Release | : 2024-02-21 |
| Genre | : Science |
| ISBN | : 2832545033 |
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).
| Author | : Ene I. Ette |
| Publisher | : John Wiley & Sons |
| Total Pages | : 1236 |
| Release | : 2013-03-14 |
| Genre | : Medical |
| ISBN | : 1118679512 |
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.
| Author | : Jonathan Knights |
| Publisher | : |
| Total Pages | : 304 |
| Release | : 2013 |
| Genre | : |
| ISBN | : |
The following dissertation develops an information-theoretic computational framework, and shows applications for analysis of high-dimensional datasets such as those routinely encountered when conducting pharmacogenetic/genomic clinical trials. The successful application of information-theoretic concepts in pharmaceutical datasets provides a novel set of pharmacometric tools that may be leveraged to increase learning on genome scale datasets. A series of novel algorithms coded in the javaTM programming language with computational roots in information theory were extended and utilized as the basis for the methodology. Simulations and actual clinical datasets representing a broad range of complexity were utilized to highlight the capabilities of the computational approach on high-dimensional datasets. Additionally, the work was compared to existing methodologies on both theoretical and practical levels.^The results suggest that an information-theoretic analytical platform offers an appropriately flexible and computationally efficient basis for performing interaction analyses on high-dimensional data sets. In most cases, the proposed methods performed comparably to, or better than, existing methodologies when the size of the data set was not prohibitive for traditional approaches: These results held across all levels of complexity, and for clinical data as well simulated data. In situations where multiple types of relationships may exist and there is no specific need for a structural parameterization, the information-theoretic approach proposed here may serve as an appropriate analytical platform, capable of detecting novel interactions and informative relationships.^The algorithms that have been extended here are computationally efficient enough to allow detection of higher-order relationships in genome-scale data sets on common laboratory computers, negating the need for access to sophisticated computational facilities. Thus, the advancements realized by this work are as much theoretical as they are practical.
| Author | : Steven Piantadosi |
| Publisher | : Springer Nature |
| Total Pages | : 2573 |
| Release | : 2022-07-19 |
| Genre | : Medical |
| ISBN | : 3319526367 |
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.
| Author | : Bairong Shen |
| Publisher | : Springer |
| Total Pages | : 331 |
| Release | : 2016-10-31 |
| Genre | : Science |
| ISBN | : 9811015031 |
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.
| Author | : Andrew E. Mulberg |
| Publisher | : John Wiley & Sons |
| Total Pages | : 782 |
| Release | : 2013-05-20 |
| Genre | : Medical |
| ISBN | : 1118312058 |
Most medicines have never been adequately tested for safety and efficacy in pediatric populations and preterm, infants and children are particularly vulnerable to adverse drug reactions. Pediatric Drug Development: Concepts and Applications, Second Edition, addresses the unique challenges in conducting effective drug research and development in pediatric populations. This new edition covers the legal and ethical issues of consent and assent, the additional legal and safety protections for children, and the appropriate methods of surveillance and assessment for children of varying ages and maturity, particularly for patient reported outcomes. It includes new developments in biomarkers and surrogate endpoints, developmental pharmacology and other novel aspects of global pediatric drug development. It also encompasses the new regulatory initiatives across EU, US and ROW designed to encourage improved access to safe and effective medicines for children globally. From an international team of expert contributors Pediatric Drug Development: Concepts and Applications is the practical guide to all aspects of the research and development of safe and effective medicines for children.
| Author | : Hartmut Derendorf |
| Publisher | : Lippincott Williams & Wilkins |
| Total Pages | : 864 |
| Release | : 2019-07-11 |
| Genre | : Medical |
| ISBN | : 1496385896 |
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.
| Author | : Johan Gabrielsson |
| Publisher | : CRC Press |
| Total Pages | : 926 |
| Release | : 2001-11-30 |
| Genre | : Medical |
| ISBN | : 9789186274924 |
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.
| Author | : Stephan Schmidt |
| Publisher | : Springer |
| Total Pages | : 570 |
| Release | : 2014-12-01 |
| Genre | : Medical |
| ISBN | : 1493913042 |
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.
| Author | : Bruce H. Littman |
| Publisher | : Cambridge University Press |
| Total Pages | : 385 |
| Release | : 2011-01-31 |
| Genre | : Medical |
| ISBN | : 113949872X |
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.
