Physiologically-Based Pharmacokinetic (PBPK) Modeling and Simulations: Principles, Methods, and Applications in the Pharmaceutical Industry ist das einzige Buch seiner Art, das sich an die schnell wachsende Gemeinschaft der PBPK-Anwender richtet und in klaren, pragnanten Worten die Grundlagen darstellt. Durch die Verbindung von Theorie und Praxis wird in diesem Werk das unglaubliche Potenzial der PBPK-Modellierung fur die Verbesserung der Entdeckung und Entwicklung von Arzneimitteln betrachtet. In der neuen Ausgabe wird der Schwerpunkt starker auf Anwendungen und relevante Fallstudien gelegt. Ausserdem gibt es eine begleitende Website mit Datensatzen, die viele der wichtigsten Entwicklungen im Bereich der PBPK-Modellierung und -Simulation seit der Veroeffentlichung der ersten Ausgabe im Jahr 2012 abbilden.

Overcoming Obstacles in Drug Discovery and Development uses real-world case studies to illustrate how critical thinking and problem solving skills are applied in the discovery and development of drugs. It also shows how developing critical thinking to overcome issues plays an essential role in the process. Modern drug discovery and development is a highly complex undertaking that requires scientific and professional expertise to be successful. After the identification of a molecular entity for treating a medical condition, challenges inevitably arise during the subsequent development to understand and characterize the biological profile; feedback from scientists is used to fine-tune the molecular entity to obtain an effective and safe product. In this process, the discovery team may identify unexpected safety issues and new medical disorders for treatment by the molecular entity. Invariably inherent in this complex undertaking are miscues, mistakes, and unexpected problems that can derail development and throw timetables into disarray, potentially leading to failure in the development of a medically useful drug. Addressing critical unexpected problems during development often requires scientists to utilize critical thinking and imaginative problem-solving skills. Overcoming Obstacles in Drug Discovery and Development will be essential to young scientists to help learn the skills to successfully face challenges, learn from mistakes, and further develop critical thinking skills. It will also be beneficial to experienced researchers who can learn from the case studies of successful and unsuccessful drug development.

Brain Targeted Drug Delivery Systems: A Focus on Nanotechnology and Nanoparticulates provides a guide on nanoparticulates to both academic and industry researchers. The book discusses key points in the development of brain targeted drug delivery, summarizes available strategies, and considers the main problems and pitfalls evidenced in current studies on brain targeted drug delivery systems. As the brain is the most important organ in the human body, and disorders of the central nervous system (CNS) are the most serious threat to human life, this book highlights advances and new research in drug delivery methods to the brain.

New Developments for Nanosensors in Pharmaceutical Analysis presents an overview of developments in nanosensor usage in pharmaceutical analysis, thereby helping pharmaceutical companies attain reliable, precise, and accurate analysis of pharmaceuticals. This book presents very simple, precise, sensitive, selective, fast, and relatively inexpensive methods for pre-treatment, prior to analysis. These methods may be considered for further application in clinical studies and assays. The book includes the manufacturing of sensors for pharmaceutical analysis at nano- or smaller scales, and gives simple and relatable designs for the fabrication of sensors. Twelve chapters cover an introduction to the topic, immobilization techniques, mechanism effect of nanomaterials on structure, optical nanosensors for pharmaceutical detection, chemical nanosensors in pharmaceutical analysis, noble metal nanoparticles in electrochemical analysis of drugs, photo-electrochemical nanosensors for drug analysis, molecularly imprinted polymer based nanosensors for pharmaceutical analysis, nanomaterials for drug delivery systems, nanomaterials enriched nucleic acid-based biosensors, nanosensors in biomarker detection, and nanomaterials-based enzyme biosensors for electrochemical applications.

Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 40, first published in 1977, and continually published as a yearly update to the voluminous encyclopedia Meyler's Side Effects of Drugs, presents clinicians and medical investigators with a reliable and critical survey of new data and trends in the area of adverse drug reactions and interactions, with an international team of specialists contributing each year. Topics covered in this release include Central Nervous System Stimulants and Drugs that Suppress Appetite, Antidepressant drugs, Lithium, Drugs of abuse, Hypnotics and sedatives, Antipsychotic Drugs, and much more.

Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. It also covers the industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases, and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences.

Medicinal Chemistry of Chemotherapeutic Agents: A Comprehensive Resource of Anti-infective and Anti-cancer Drugs focuses on the basics and fundamentals of chemistry involved in chemotherapeutic agents. Each chapter comprises distinct chemical classifications that include structure and IUPAC nomenclature, synthetic schemes and routes for each drug, mechanism of the drug action, metabolic pathway and structure-activity relationship (SAR) studies. The book covers current research focused on drug resistance and methods to overcome it, the development of newer drugs belonging to each category of the chemotherapeutic agents, molecules currently under clinical trials, and newly approved drugs, if any. This book will be a valuable resource for academics and researchers, helping them to understand the fundamentals of the medicinal chemistry of the chemotherapeutic agents.

Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into ‘building blocks’ that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry.