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出版者:John Wiley & Sons Inc

作者:Ette, Ene I. (EDT)/ Williams, Paul J. (EDT)

出品人:

页数:1216

译者:

出版时间:2007-4

价格:1582.00 元

装帧:HRD

isbn号码:9780471677833

丛书系列:

图书标签:

• 药代动力学
• 药效动力学
• 药物代谢
• 药物研发
• 建模与仿真
• 临床药理学
• 生物统计学
• 非线性混合效应模型
• 药物剂量优化
• PK/PD建模

药效计量学：精准释放药物潜能的艺术与科学 在这本深入探讨药效计量学的专著中，我们 embarked on a profound journey into the intricate world of drug development and optimization. This book is not merely a collection of facts and figures; it is a rigorous exploration of the principles and methodologies that underpin our ability to understand, predict, and ultimately control how medicines behave within the human body and exert their therapeutic effects. Our aim is to equip readers with a comprehensive toolkit, not only for analyzing existing drug data but also for strategically designing and evaluating new therapeutic interventions. The field of pharmacometrics, at its core, is the science of quantifying drug effects. It bridges the gap between pharmacology, physiology, and statistics, providing a robust framework for understanding the complex interplay between drug concentration and response. This book delves deep into the foundational concepts, starting with the pharmacokinetic-pharmacodynamic (PK/PD) models that form the bedrock of modern drug evaluation. We meticulously dissect the components of these models, exploring how they capture the absorption, distribution, metabolism, and excretion (ADME) of a drug – the ADME profile that dictates its journey through the body. Understanding these processes is paramount to designing dosing regimens that achieve the desired therapeutic effect while minimizing the risk of adverse events. We dedicate significant attention to the statistical underpinnings of pharmacometric analysis. Bayesian methods, a cornerstone of modern pharmacometrics, are explored in detail. Readers will gain a deep appreciation for how Bayesian approaches allow for the incorporation of prior knowledge, the estimation of uncertainty, and the flexible modeling of complex biological systems. The book covers various statistical techniques, including non-linear mixed-effects modeling (NLME), which is indispensable for analyzing population data and identifying factors that influence drug response, such as age, weight, organ function, and genetic variations. We illustrate these concepts with illustrative examples, demonstrating how to build, validate, and interpret complex statistical models. A substantial portion of the book is dedicated to the practical application of pharmacometric principles in drug development. We guide readers through the drug development pipeline, from preclinical studies to post-market surveillance. For each stage, we highlight the critical role of pharmacometrics in informed decision-making. In early development, pharmacometric models help in selecting optimal doses for first-in-human studies and in designing efficient clinical trials. As development progresses, these models are refined to predict drug behavior in specific patient populations, guiding the design of pivotal clinical trials. The book emphasizes the importance of model-based meta-analysis and population PK/PD modeling for synthesizing evidence from multiple studies and identifying sources of variability in drug response. Furthermore, this book provides in-depth coverage of specific modeling approaches and their applications. We explore the nuances of modeling therapeutic effects, including efficacy endpoints and toxicity outcomes. The challenges and strategies for modeling complex pharmacological phenomena, such as drug-drug interactions, disease progression, and the development of resistance, are meticulously examined. Special attention is given to the modeling of specific drug classes, including antibiotics, anticancer agents, and drugs for chronic diseases, showcasing the versatility and adaptability of pharmacometric methodologies across diverse therapeutic areas. The book also addresses the critical aspect of quantitative systems pharmacology (QSP). QSP represents an evolution of traditional PK/PD modeling, aiming to integrate biological pathway information with drug disposition and effect. We delve into the principles of QSP, exploring how it can be used to gain a mechanistic understanding of drug action and to predict the impact of drug interventions on complex biological networks. This advanced perspective is crucial for tackling complex diseases and for developing novel therapeutic strategies. A significant emphasis is placed on the role of pharmacometrics in personalized medicine. We explore how pharmacometric models can be used to tailor drug therapy to individual patients, optimizing dosing regimens based on their unique characteristics and clinical status. This includes the application of therapeutic drug monitoring (TDM) and the development of model-informed precision dosing strategies. The book highlights how pharmacometrics can contribute to achieving optimal treatment outcomes, minimizing side effects, and improving patient adherence. Beyond the technical aspects, this book underscores the collaborative nature of pharmacometrics. We emphasize the importance of effective communication and collaboration between pharmacometricians, clinicians, statisticians, and other stakeholders in the drug development process. The book provides insights into how to effectively communicate complex model-based findings to non-experts, fostering informed decision-making and facilitating the translation of scientific knowledge into clinical practice. Throughout the book, we integrate real-world case studies and examples to illustrate the practical application of pharmacometric principles. These case studies are carefully selected to demonstrate the diverse applications of pharmacometrics in addressing critical challenges in drug development and clinical practice. They showcase how pharmacometric approaches have led to significant advancements in optimizing drug therapy, improving patient outcomes, and enhancing the efficiency of drug development. In conclusion, this book is designed to be an indispensable resource for researchers, clinicians, and students interested in the quantitative evaluation of drug effects. By delving into the fundamental principles, advanced methodologies, and practical applications of pharmacometrics, readers will gain a profound understanding of how this discipline empowers us to make more informed, precise, and effective therapeutic decisions, ultimately contributing to the advancement of human health.

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