Systems Pharmacology and Pharmacodynamics


Book Description

While systems biology and pharmacodynamics have evolved in parallel, there are significant interrelationships that can enhance drug discovery and enable optimized therapy for each patient. Systems pharmacology is the relatively new discipline that is the interface between these two methods. This book is the first to cover the expertise from systems biology and pharmacodynamics researchers, describing how systems pharmacology may be developed and refined further to show practical applications in drug development. There is a growing awareness that pharmaceutical companies should reduce the high attrition in the pipeline due to insufficient efficacy or toxicity found in proof-of-concept and/or Phase II studies. Systems Pharmacology and Pharmacodynamics discusses the framework for integrating information obtained from understanding physiological/pathological pathways (normal body function system vs. perturbed system due to disease) and pharmacological targets in order to predict clinical efficacy and adverse events through iterations between mathematical modeling and experimentation.




Pharmacokinetic-Pharmacodynamic Modeling and Simulation


Book Description

This is a second edition to the original published by Springer in 2006. The comprehensive volume takes a textbook approach systematically developing the field by starting from linear models and then moving up to generalized linear and non-linear mixed effects models. Since the first edition was published the field has grown considerably in terms of maturity and technicality. The second edition of the book therefore considerably expands with the addition of three new chapters relating to Bayesian models, Generalized linear and nonlinear mixed effects models, and Principles of simulation. In addition, many of the other chapters have been expanded and updated.




Quantitative Systems Pharmacology


Book Description

Quantitative Systems Pharmacology: Models and Model-Based Systems with Applications, Volume 42, provides a quantitative approach to problem-solving that is targeted to engineers. The book gathers the contributions of doctors, pharmacists, biologists, and chemists who give key information on the elements needed to model a complex machine like the human body. It presents information on diagnoses, administration and release of therapeutics, distribution metabolism and excretion of drugs, compartmental pharmacokinetics, physiologically-based pharmacokinetics, pharmacodynamics, identifiability of models, numerical methods for models identification, design of experiments, in vitro and in vivo models, and more. As the pharma community is progressively acknowledging that a quantitative and systematic approach to drug administration, release, pharmacokinetics and pharmacodynamics is highly recommended to understand the mechanisms and effects of drugs, this book is a timely resource. - Outlines a model-based approach (based on Process Systems Engineering-OSE and Computer Aided Process Engineering-CAPE) in quantitative pharmacology - Explains how therapeutics work in the human body and how anatomy and physiology influences drug efficacy - Discusses how drugs are driven to specific targets using nanoparticles - Offers insight into how in vitro and in vivo experiments help understand the drug mechanism of action and optimize their performance - Includes case studies showing the positive outcome of these methods in personalized therapies, therapeutic drug monitoring, clinical trials analysis and drug formulation




ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins


Book Description

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




Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics


Book Description

This book presents a novel modeling approach to biopharamceutics, pharmacokinetics and pharmacodynamic phenomena. It shows how advanced physical and mathematical methods can expand classical models in order to cover heterogeneous drug-biological processes and therapeutic effects in the body. Throughout, many examples are used to illustrate the intrinsic complexity of drug administration related phenomena in the human, justifying the use of advanced modeling methods.




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


Book Description

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.




Study Guide to Accompany Drug Therapy in Nursing


Book Description

The perfect companion to Drug Therapy in Nursing, Second Edition, this invaluable study partner delivers guidance on individual patient management from a nurse-as-caregiver perspective, helping you build essential knowledge and develop sound practice skills. Knowledge-building features include Top Ten Things to Know lists, key terms, multiple-choice questions, case studies, and critical thinking challenges. A "Just the Facts" feature helps deepen your understanding of essential drugs, their actions, indications, contraindications, and cautions. A "Patients Please" feature helps you put the needs of the patient first, with facts on core patient variables.




Pharmacokinetics and Pharmacodynamics of Biotech Drugs


Book Description

This first ever coverage of the pharmacokinetic and pharmacodynamic characteristics of biopharmaceuticals meets the need for a comprehensive book in this field. It spans all topics from lead identification right up to final-stage clinical trials. Following an introduction to the role of PK and PD in the development of biotech drugs, the book goes on to cover the basics, including the pharmacokinetics of peptides, monoclonal antibodies, antisense oligonucleotides, as well as viral and non-viral gene delivery vectors. The second section discusses such challenges and opportunities as pulmonary delivery of proteins and peptides, and the delivery of oligonucleotides. The final section considers the integration of PK and PD concepts into the biotech drug development plan, taking as case studies the preclinical and clinical drug development of tasidotin, as well as the examples of cetuximab and pegfilgrastim. The result is vital reading for all pharmaceutical researchers.




Basic and Clinical Pharmacology 15e


Book Description

Master key pharmacological concepts and practices with the most comprehensive, authoritative guide available Doody's Core Titles for 2023! Presented in full-color and packed with hundreds of illustrations, Basic and Clinical Pharmacology is the wide-ranging, engaging guide students have counted on for decades. Organized to reflect the course sequence in many pharmacology courses and in integrated curricula, the guide covers the important concepts students need to know about the science of pharmacology and its application to clinical practice. This edition has been extensively updated to provide expanded coverage of transporters, pharmacogenomics, and new drugs Delivers the knowledge and insight needed to excel in every facet of pharmacology!. Encompasses all aspects of medical pharmacology, including botanicals and over-the-counter drugs Major revisions of the chapters on immunopharmacology, antiseizure, antipsychotic, antidepressant, antidiabetic, anti-inflammatory, and antiviral drugs, prostaglandins, and central nervous system neurotransmitters New chapter on the increasingly relevant topic of cannabis pharmacology Each chapter opens with a case study, covers drug groups and prototypes, and closes with summary tables and diagrams that encapsulate important information Revised full-color illustrations provide more information about drug mechanisms and effects and help clarify important concepts Trade Name/Generic Name tables are provided at end of each chapter for easy reference when writing a chart order or prescription Includes descriptions of important new drugs released through May 2019 New and updated coverage of general concepts relating to recently discovered receptors, receptor mechanisms, and drug transporters




Basic Pharmacokinetics and Pharmacodynamics


Book Description

With its clear, straightforward presentation, this text enables you to grasp all the fundamental concepts of pharmacokinetics and pharmacodynamics. This will allow you to understand the time course of drug response and dosing regimen design. Clinical models for concentration and response are described and built from the basic concepts presented in earlier chapters. Your understanding of the material will be enhanced by guided computer exercises conducted on a companion website. Simulations will allow you to visualize drug behavior, experiment with different dosing regimens, and observe the influence of patient characteristics and model parameters. This makes the book ideal for self-study. By including clinical models of agonism, indirect drug effects, tolerance, signal transduction, and disease progression, author Sara Rosenbaum has created a work that stands out among introductory-level textbooks in this area.You'll find several features throughout the text to help you better understand and apply key concepts: Three fictitious drugs are used throughout the text to progressively illustrate the development and application of pharmacokinetic and pharmacodynamic principles Exercises at the end of each chapter reinforce the concepts and provide the opportunity to perform and solve common dosing problems Detailed instructions let you create custom Excel worksheets to perform simple pharmacokinetic analyses Because this is an introductory textbook, the material is presented as simply as possible. As a result, you'll find it easy to gain an accurate, working knowledge of all the core principles, apply them to optimize dosing regimens, and evaluate the clinical pharmacokinetic and pharmacodynamic literature.