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The Art and Science of Physiologically-Based Pharmacokinetics Modeling
This state-of-the-art text describes the science behind the system and drug-dependent components of PBPK models, its applications in translational and regulatory science, e.g., guiding drug discovery and development, and supporting precision medicine initiatives. To incorporate state-of-the-art knowledge, each chapter is written by leaders in the field and illustrated by clear case studies. Connecting basic and applied science, this book explores the potential of PBPK modeling for improving therapeutics and is designed for a wide audience encompassing graduate students as well as biopharmaceutics scientists and clinical pharmacologists. Features: 1. Provides a basic understanding of the physiologically-based pharmacokinetic modeling and its applications 2. Assists the reader in understanding product performance to allow for rapid product development and establish bioequivalence 3. Well-constructed content and added value of real examples 4. Illustrates how using available resources via modeling and simulation leads to a reduction in the costs related to drug development, which directly affects the costs to patients
Biosimulation in Biomedical Research, Health Care and Drug Development
Biosimulation is an approach to biomedical research and the treatment of patients in which computer modeling goes hand in hand with experimental and clinical work. Constructed models are used to interpret experimental results and to accumulate information from experiment to experiment. This book explains the concepts used in the modeling of biological phenomena and goes on to present a series of well-documented models of the regulation of various genetic, cellular and physiological processes. The way how the use of computer models allows optimization of cancer treatment for individual patients is discussed and models of interacting nerve cells that can be used to design new treatments for patients with Parkinson's disease are explained. Furthermore this volume provides an overview on the use of models in industry, and presents the view of regulatory agencies on the topic.
Precision Medicine: Impact of Cytochromes P450 and Transporters Genetic Polymorphisms, Drug-Drug Interactions, Disease on Safety and Efficacy of Drugs
Topic Editor Professor Amin Rostami is the Senior Vice President of Research & Development and Chief Scientific Officer at Certara. All other Topic Editors declare no competing interests with regards to the Research Topic subject.
Metabolite Safety in Drug Development
A reference on drug metabolism and metabolite safety in the development phase, this book reviews the analytical techniques and experimental designs critical for metabolite studies. It features case studies of lessons learned and real world examples, along with regulatory perspectives from the US FDA and EMA. • Reviews the analytical techniques and experimental designs critical for metabolite studies • Covers methods including chirality, species differences, mass spectrometry, radiolabels, and in vitro / in vivo correlation • Discusses target pharmacology, in vitro systems aligned to toxicity tests, and drug-drug interactions • Includes perspectives from authors with firsthand involvement in industry and the study of drug metabolites, including viewpoints that have influenced regulatory guidelines
Biosimulation in Drug Development
This first comprehensive survey to cover all pharmaceutically relevant topics provides a comprehensive introduction to this novel and revolutionary tool, presenting both concepts and application examples of biosimulated cells, organs and organisms. Following an introduction to the role of biosimulation in drug development, the authors go on to discuss the simulation of cells and tissues, as well as simulating drug action and effect. A further section is devoted to simulating networks and populations, and the whole is rounded off by a look at the potential for biosimulation in industrial drug development and for regulatory decisions. Part of the authors are members of the BioSim Network of Excellence that encompasses more than 40 academic institutions, pharmaceutical companies and regulatory authorities dealing with drug development; other contributors come from industry, resulting in a cross-disciplinary expert reference.
Transporters in Drug Development
Transporters in Drug Development examines how membrane transporters can be dealt with in academic–industrial drug discovery and pharmaceutical development as well as from a regulatory perspective. The book describes methods and examples of in vitro characterization of single transporters in the intestines, liver and kidneys as well as characterization of substrate overlap between various transporters. Furthermore, probes and biomarkers are suggested for studies of the transporters’ impact on the pharmacokinetics of drug substrates/candidates interacting on transporters. The challenges of translating in vitro observed interaction of transporters into in vivo relevance are explored, and the book highlights perspectives of applying targeted proteomics and mechanistic modeling in this process.
Physiologically Based Pharmacokinetic (PBPK) Modeling and Simulations
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 ...
Oral Drug Delivery for Modified Release Formulations
ORAL DRUG DELIVERY FOR MODIFIED RELEASE FORMULATIONS Provides pharmaceutical development scientists with a detailed reference guide for the development of MR formulations Oral Drug Delivery for Modified Release Formulations is an up-to-date review of the key aspects of oral absorption from modified-release (MR) dosage forms. This edited volume provides in-depth coverage of the physiological factors that influence drug release and of the design and evaluation of MR formulations. Divided into three sections, the book begins by describing the gastrointestinal tract (GIT) and detailing the conditions and absorption processes occurring in the GIT that determine a formulation’s oral bioavailabil...
Handbook of Personalized Medicine
This book compiles multidisciplinary efforts to conceptualize the environment in research and clinical setting that creates the fertile ground for the practical utility of personalized medicine decisions and also enables clinical pharmacogenomics for establishing pharmacotyping in drug prescription. Its covers innovative drug formulations and nanot
The Emerging Discipline of Quantitative Systems Pharmacology
In 2011, the National Institutes of Health (NIH), in collaboration with leaders from the pharmaceutical industry and the academic community, published a white paper describing the emerging discipline of Quantitative Systems Pharmacology (QSP), and recommended the establishment of NIH-supported interdisciplinary research and training programs for QSP. QSP is still in its infancy, but has tremendous potential to change the way we approach biomedical research. QSP is really the integration of two disciplines that have been increasingly useful in biomedical research; “Systems Biology” and “Quantitative Pharmacology”. Systems Biology is the field of biomedical research that seeks to under...
