Innovative Pharmacometric Approaches To Inform Drug Development And Clinical Use

Innovative Pharmacometric Approaches To Inform Drug Development And Clinical Use Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Innovative Pharmacometric Approaches To Inform Drug Development And Clinical Use book. This book definitely worth reading, it is an incredibly well-written.

Innovative Pharmacometric Approaches to Inform Drug Development and Clinical Use

Zinnia P. Parra-Guillen,Victor Mangas Sanjuan,Maria Garcia-Cremades,Hugo Geerts
Innovative Pharmacometric Approaches to Inform Drug Development and Clinical Use Book PDF

Author : Zinnia P. Parra-Guillen,Victor Mangas Sanjuan,Maria Garcia-Cremades,Hugo Geerts
Publisher : Frontiers Media SA
Page : 117 pages
File Size : 52,9 Mb
Release : 2024-02-21
Category : Science
ISBN : 9782832545034

Get Book

Innovative Pharmacometric Approaches to Inform Drug Development and Clinical Use by Zinnia P. Parra-Guillen,Victor Mangas Sanjuan,Maria Garcia-Cremades,Hugo Geerts Pdf

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).

Translational Biomedical Informatics

Bairong Shen,Haixu Tang,Xiaoqian Jiang
Translational Biomedical Informatics Book PDF

Author : Bairong Shen,Haixu Tang,Xiaoqian Jiang
Publisher : Springer
Page : 332 pages
File Size : 42,6 Mb
Release : 2016-10-31
Category : Science
ISBN : 9789811015038

Get Book

Translational Biomedical Informatics by Bairong Shen,Haixu Tang,Xiaoqian Jiang Pdf

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.

Pharmacometrics

Ene I. Ette,Paul J. Williams
Pharmacometrics Book PDF

Author : Ene I. Ette,Paul J. Williams
Publisher : John Wiley & Sons
Page : 1236 pages
File Size : 48,5 Mb
Release : 2013-03-14
Category : Medical
ISBN : 9781118679517

Get Book

Pharmacometrics by Ene I. Ette,Paul J. Williams Pdf

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.

Pediatric Drug Development

Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Pediatric Drug Development Book PDF

Author : Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis
Publisher : John Wiley & Sons
Page : 782 pages
File Size : 43,9 Mb
Release : 2013-05-20
Category : Medical
ISBN : 9781118312056

Get Book

Pediatric Drug Development by Andrew E. Mulberg,Dianne Murphy,Julia Dunne,Lisa L. Mathis Pdf

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.

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications

Hartmut Derendorf,Stephan Schmidt
Rowland and Tozer s Clinical Pharmacokinetics and Pharmacodynamics Concepts and Applications Book PDF

Author : Hartmut Derendorf,Stephan Schmidt
Publisher : Lippincott Williams & Wilkins
Page : 864 pages
File Size : 50,6 Mb
Release : 2019-07-11
Category : Medical
ISBN : 9781496385895

Get Book

Rowland and Tozer's Clinical Pharmacokinetics and Pharmacodynamics: Concepts and Applications by Hartmut Derendorf,Stephan Schmidt Pdf

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.

Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition

Johan Gabrielsson,Daniel Weiner
Pharmacokinetic and Pharmacodynamic Data Analysis Concepts and Applications Third Edition Book PDF

Author : Johan Gabrielsson,Daniel Weiner
Publisher : CRC Press
Page : 926 pages
File Size : 46,5 Mb
Release : 2001-11-30
Category : Medical
ISBN : 9186274929

Get Book

Pharmacokinetic and Pharmacodynamic Data Analysis: Concepts and Applications, Third Edition by Johan Gabrielsson,Daniel Weiner Pdf

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.

Applied Pharmacometrics

Stephan Schmidt,Hartmut Derendorf
Applied Pharmacometrics Book PDF

Author : Stephan Schmidt,Hartmut Derendorf
Publisher : Springer
Page : 565 pages
File Size : 48,7 Mb
Release : 2014-12-01
Category : Medical
ISBN : 9781493913046

Get Book

Applied Pharmacometrics by Stephan Schmidt,Hartmut Derendorf Pdf

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.

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

Honghui Zhou,Frank-Peter Theil
ADME and Translational Pharmacokinetics Pharmacodynamics of Therapeutic Proteins Book PDF

Author : Honghui Zhou,Frank-Peter Theil
Publisher : John Wiley & Sons
Page : 472 pages
File Size : 53,9 Mb
Release : 2015-10-26
Category : Medical
ISBN : 9781118898802

Get Book

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins by Honghui Zhou,Frank-Peter Theil Pdf

With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve biologics drug development for monoclonal antibodies, fusion proteins, pegylated proteins, ADCs, bispecifics, and vaccines • Presents regulatory expectations and industry perspectives for developing biologic drugs in USA, EU, and Japan • Provides mechanistic insight into biodistribution and target-driven pharmacokinetics in important sites of action such as tumors and the brain

Translational Medicine and Drug Discovery

Bruce H. Littman,Rajesh Krishna
Translational Medicine and Drug Discovery Book PDF

Author : Bruce H. Littman,Rajesh Krishna
Publisher : Cambridge University Press
Page : 385 pages
File Size : 52,6 Mb
Release : 2011-01-31
Category : Medical
ISBN : 9781139498722

Get Book

Translational Medicine and Drug Discovery by Bruce H. Littman,Rajesh Krishna Pdf

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.

Encyclopedia of Pharmacy Practice and Clinical Pharmacy

Anonim
Encyclopedia of Pharmacy Practice and Clinical Pharmacy Book PDF

Author : Anonim
Publisher : Academic Press
Page : 2370 pages
File Size : 43,9 Mb
Release : 2019-06-28
Category : Medical
ISBN : 9780128127360

Get Book

Encyclopedia of Pharmacy Practice and Clinical Pharmacy by Anonim Pdf

Encyclopedia of Pharmacy Practice and Clinical Pharmacy, Three Volume Set covers definitions, concepts, methods, theories and applications of clinical pharmacy and pharmacy practice. It highlights why and how this field has a significant impact on healthcare. The work brings baseline knowledge, along with the latest, most cutting-edge research. In addition, new treatments, algorithms, standard treatment guidelines, and pharmacotherapies regarding diseases and disorders are also covered. The book's main focus lies on the pharmacy practice side, covering pharmacy practice research, pharmacovigilance, pharmacoeconomics, social and administrative pharmacy, public health pharmacy, pharmaceutical systems research, the future of pharmacy, and new interventional models of pharmaceutical care. By providing concise expositions on a broad range of topics, this book is an excellent resource for those seeking information beyond their specific areas of expertise. This outstanding reference is essential for anyone involved in the study of pharmacy practice. Provides a ‘one-stop’ resource for access to information written by world-leading scholars in the field Meticulously organized, with articles split into three clear sections, it is the ideal resource for students, researchers and professionals to find relevant information Contains concise and accessible chapters that are ideal as an authoritative introduction for non-specialists and readers from the undergraduate level upwards Includes multimedia options, such as hyperlinked references and further readings, cross-references and videos

The Prevention and Treatment of Missing Data in Clinical Trials

National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
The Prevention and Treatment of Missing Data in Clinical Trials Book PDF

Author : National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials
Publisher : National Academies Press
Page : 163 pages
File Size : 46,7 Mb
Release : 2010-12-21
Category : Medical
ISBN : 9780309186513

Get Book

The Prevention and Treatment of Missing Data in Clinical Trials by National Research Council,Division of Behavioral and Social Sciences and Education,Committee on National Statistics,Panel on Handling Missing Data in Clinical Trials Pdf

Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Translational Medicine in CNS Drug Development

George G. Nomikos,Douglas E. Feltner
Translational Medicine in CNS Drug Development Book PDF

Author : George G. Nomikos,Douglas E. Feltner
Publisher : Academic Press
Page : 458 pages
File Size : 53,6 Mb
Release : 2019-06-18
Category : Medical
ISBN : 9780128031643

Get Book

Translational Medicine in CNS Drug Development by George G. Nomikos,Douglas E. Feltner Pdf

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

Clinical Trial Simulations

Holly H. C. Kimko,Carl C. Peck
Clinical Trial Simulations Book PDF

Author : Holly H. C. Kimko,Carl C. Peck
Publisher : Springer Science & Business Media
Page : 540 pages
File Size : 53,9 Mb
Release : 2010-12-09
Category : Medical
ISBN : 9781441974150

Get Book

Clinical Trial Simulations by Holly H. C. Kimko,Carl C. Peck Pdf

This edition includes both updates and new uses and issues concerning CTS, along with case studies of how clinical trial simulations are being applied in various therapeutic and application areas. Importantly, the book expands on the utility of CTS for informing decisions during drug development and regulatory review. Each chapter author was selected on the basis of demonstrated expertise in state-of-the-art application of CTS. The target audience for this volume includes researchers and scientists who wish to consider use of simulations in the design, analysis, or regulatory review and guidance of clinical trials. This book does not embrace all aspects of trial design, nor is it intended as a complete recipe for using computers to design trials. Rather, it is an information source that enables the reader to gain understanding of essential background and knowledge for practical applications of simulation for clinical trial design and analysis. It is assumed that the reader has a working understanding of pharmacokinetics and pharmacodynamics, modeling, pharmacometric analyses, and/or the drug development and regulatory processes.

Basic Pharmacokinetics

Mohsen A. Hedaya
Basic Pharmacokinetics Book PDF

Author : Mohsen A. Hedaya
Publisher : Taylor & Francis
Page : 464 pages
File Size : 54,6 Mb
Release : 2023-09-13
Category : Medical
ISBN : 9781000921984

Get Book

Basic Pharmacokinetics by Mohsen A. Hedaya Pdf

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.

Imaging for Clinical Oncology

Peter Hoskin,Thankamma Ajithkumar,Vicky Goh
Imaging for Clinical Oncology Book PDF

Author : Peter Hoskin,Thankamma Ajithkumar,Vicky Goh
Publisher : Oxford University Press
Page : 401 pages
File Size : 40,9 Mb
Release : 2021
Category : Medical
ISBN : 9780198818502

Get Book

Imaging for Clinical Oncology by Peter Hoskin,Thankamma Ajithkumar,Vicky Goh Pdf

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.