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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
Bioequivalence Requirements in Various Global Jurisdictions
Although the Bioequivalence (BE) requirements in many global jurisdictions have much in common, differences in certain approaches and requirements such as definitions and terms, choice of comparator (reference) product, acceptance criteria, fasted and fed studies, single and multi-dose studies, biowaivers and products not intended for absorption into the systemic circulation (locally acting medicines and dosage forms), amongst others, provide food for thought that standardisation should be a high priority objective in order to result in a harmonized international process for the market approval of products using BE. An important objective of Bioequivalence Requirements in Various Global Juri...
The ADME Encyclopedia
The ADME Encyclopedia covers pharmacokinetic phenomena (Absorption, Distribution, Metabolism and Excretion processes) and their relationship with the design of pharmaceutical carriers and the success of drug therapies. It covers both basic and advanced knowledge, serving as introductory material for students of biomedical careers and also as reference, updated material for graduates and professionals working in any field related to pharmaceutical sciences (medicine, pharmaceutical technology, materials science, medicinal chemistry). Structured as alphabetically ordered entries with cross-references, the Encyclopedia not only provides basic knowledge on ADME processes, but also detailed entries on some advanced subjects such as drug transporters, last generation pharmaceutical carriers, pharmacogenomics, personalized medicine, bioequivalence studies, biowaivers, biopharmaceuticals, gene delivery, pharmacometrics, pharmacokinetic drug interactions or in silico and in vitro assessment of ADME properties
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. In order to incorporate the 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, the 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 modelling 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
Generic Drug Product Development
In this era of increased pharmaceutical industry competition, success for generic drug companies is dependent on their ability to manufacture therapeutic-equivalent drug products in an economical and timely manner, while also being cognizant of patent infringement and other legal and regulatory concerns.Generic Drug Product Development: Solid Oral
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World Heritage Patinas
This book presents studies on the management of the Brazilian world heritage and its international counterparts, relating its preservationist practices to the risks and alerts that run its maintenance in the face of so many challenges in the contemporary world. The book has encouraged scholars from a wide variety of disciplines to contribute their valuable knowledge to research on the management and risks of Brazil's world heritage. It is a bold initiative that brings together contemporary studies on management, alerts and risks of the Brazilian world heritage and some international examples. It stands out not only for its interdisciplinary approach, but above all for compiling a wide range of approaches that analyze various dimensions of world heritage management. Unique experience in the management of world heritage allocated to Brazilian territory, this book was written by prominent academics and heritage management professionals and includes national and international case studies. It is a comprehensive academic book in Brazilian world heritage management literature and can therefore be used as an authoritative reference source as well as a significant teaching tool.
Crime and Art
This volume brings together work by authors who draw upon sociological and criminological methods, theory, and frameworks, to produce research that pushes boundaries, considers new questions, and reshape the existing understanding of "art crimes", with a strong emphasis on methodological innovation and novel theory application. Criminologists and sociologists are poorly represented in academic discourse on art and culture related crimes. However, to understand topics like theft, security, trafficking, forgery, vandalism, offender motivation, the efficacy of and results of policy interventions, and the effects art crimes have on communities, we must develop the theoretical and methodological models we use for analyses. The readership of this book is expected to include academics, researchers, and practitioners in the fields of criminology, sociology, law, and heritage studies who have an interest in art and heritage crime.
