Clinical Trial Project Management provides a detailed overview of how to conduct clinical trials in an international context. The process of conducting clinical studies across nations is based on a set of regulatory regimes developed by respective regulatory agencies. The book focuses on clinical study protocol approval processes, Ethics Committee approval processes, clinical study feasibilities, site selection, site initiation, site monitoring, database lock, sit close-out, clinical data processing and management, SAE reporting and compensation, randomization procedure, pharmacovigilance, statistical tools, BA/BE studies, and clinical study report writing. The book comprehensively covers the entire clinical trial process of conductance. In addition, the author also incorporates the clinical trial approval processes of USFDA, EMA, and JAPAN for conducting clinical trials.
Alexander S. Shalin, Adrià Canós Valero and Andrey Miroshnichenko
November 9, 2023
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All-Dielectric Nanophotonics aims to review the underlying principles, advances and future directions of research in the field. The book reviews progress in all-dielectric metasurfaces and nanoantennas, new types of excitations, such as magnetic and toroidal modes and associated anapole states. Ultrahigh-Q resonant modes such as bound states in the continuum are covered and the promise of replacing conventional bulky optical elements with nanometer-scale structures with enhanced functionality is discussed. This book is suitable for new entrants to the field as an overview of this research area. Experienced researchers and professionals in the field may also find this book suitable as a reference.
Harish Dureja, Raimar Loebenberg, Sachin Kumar Singh + 2 more
November 4, 2023
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Advanced Drug Delivery Systems for Colonic Disorders presents state-of-the-art methods for targeted drug delivery to the colon. These methods can prolong drug half-lives, improve bioavailability, optimize pharmacokinetics, and reduce medication dosing frequency. Chapters allow readers to not only become familiar with advancements, but also understand concepts by providing illustrations, figures, and informative tables. Contents cover an overview of colonic diseases, the cellular and molecular mechanisms involved, current and traditional therapeutic approaches, biomaterials, oral drug delivery methods, targeted drug delivery, nutraceuticals and herbal medicine approaches, prebiotics, probiotics and symbiotics, nanomedicine approaches, and the status of clinical trials.This book is the perfect resources for researchers in pharma, biomaterials, and nutrition to help familiarize them with new and upcoming therapeutic methods. Research physicians in GI can also benefit from reading this book for its clinical applications.
Side Effects of Drugs Annual: A Worldwide Yearly Survey of New Data in Adverse Drug Reactions, Volume 45, first published in 1977, presents clinicians and medical investigators with a critical survey of new data and trends in adverse drug reactions and interactions. Topics covered include ADRs, ADEs and SEDs: A Bird’s Eye View, Lithium, Drugs of abuse, Side effects of drugs used in the treatment of Alzheimer's disease, Sedatives and hypnotics, Antipsychotic agents, Anti-epileptic Medications, Side effects of opioid analgesics and narcotic antagonists, Anti-inflammatory and antipyretic analgesics and drugs used in gout, Side effects of local anesthetics and therapeutic gases, and more. Other sections covered include Antihistamines (H1 receptor antagonists), Drugs that act on the respiratory tract, Positive inotropic drugs and drugs used in dysrhythmias, Beta adrenergic antagonists and antianginal drugs, Drugs acting on the cerebral and peripheral circulations, Antihypertensive drugs, and much much more.
Molecular Pharmaceutics and Nano Drug Delivery: Fundamentals and Challenges provides a thorough resource for both beginners and established scientists, bringing fundamental knowledge about key challenges of these carriers down to the molecular level. The book satisfies the need of availability of literature at single platform with the detailed knowledge to understand crucial aspects, such as regulatory, clinical, toxicological and the formulation requirements of these carriers. This is a valuable resource for graduates, pharmaceutical researchers and anyone working on aspects of pharmaceutics, molecular pharmaceutics and nano-drug/gene delivery. So called ‘novel drug delivery systems’ are numerous, with each having different approaches to their production, characterization and evaluation. The proper understanding of these dosage forms, as well as their critical attributes such as toxicity and regulatory requirements are aspects which researchers should know before they begin working on these carriers. This book provides this critical information.
Pharmacognosy: Fundamentals, Applications and Strategies, Second Edition represents a comprehensive compilation of the philosophical, scientific and technological aspects of contemporary pharmacognosy. The book examines the impact of the advanced techniques of pharmacognosy on improving the quality, safety and effectiveness of traditional medicines, and how pharmacokinetics and pharmacodynamics have a crucial role to play in discerning the relationships of active metabolites to bioavailability and function at the active sites, as well as the metabolism of plant constituents. Structured in seven parts, the book covers the foundational aspects of Pharmacognosy, the chemistry of plant metabolites, their effects, other sources of metabolites, crude drugs from animals, basic animal anatomy and physiology, technological applications and biotechnology, and the current trends in research. New to this edition is a chapter on plant metabolites and SARS-Cov-2, extensive updates on existing chapters and the development of a Laboratory Guide to support instructors execute practical activities on the laboratory setting.
Pharmaceutics: Basic Principles and Application to Pharmacy Practice, Second Edition is a valuable textbook covering the role and application of pharmaceutics within pharmacy practice. This updated resource is geared toward meeting and incorporating the current curricular guidelines on pharmaceutics and laboratory skills mandated by the American Council for Pharmacy Education. It includes a number of student-friendly features, including chapter objectives and summaries, practical examples, case studies, numerous images and key-concept text boxes. Two new chapters are included, as well as a new end of chapter section covering "critical reflections and practice applications". Divided into three sections – Physical Principles and Properties of Pharmaceutics; Practical Aspects of Pharmaceutics; and Biological Applications of Pharmaceutics – this new edition covers all aspects of pharmaceutics and providing a single and compelling source for students.
Computer-Aided Applications in Pharmaceutical Technology: Delivery Systems, Dosage Forms, and Pharmaceutical Unit Operations, Second Edition covers the fundamentals of experimental design application and interpretation in pharmaceutical technology, chemometric methods with an emphasis on their applications in process control, neural computing, data science, computer-aided biopharmaceutical characterization, as well as the application of computational fluid dynamics in pharmaceutical technology. Completely updated, the book introduces the theory and practice of computational tools through new case studies. Chapters cover Quality by Design in pharmaceutical development, overview data mining methodologies, present computer-aided formulation development, cover experimental design applications, and much more.
Nanostructured Materials: Physicochemical Chemistry Fundamentals for Energy and Environmental Applications summarizes research knowledge and helps advanced students, researchers and industrial technicians understand specific applications of nanomaterials in energy and the environment. Sections bring a strong foundational focus on the physicochemical basis of nanomaterials for these applications, the basic theory and physicochemical basis of nanomaterials, an energy and environment applications examination of typical cases, and progress. This book will appeal to researchers in the chemical sciences (inorganic and physical chemistry, coordination chemistry, molecular dynamics, electrochemistry, photocatalysis, thermocatalysis, thermodynamics, etc.), nanoscience (graphene, carbon nanotubes, nanocrystals, nano catalysis, energy, and environment-nano science), and more. Efficient use of energy, eco-friendly environmental systems, and technologies play an important role in global sustainable development. Multifunctional nanocomposites have excellent properties and can meet the practical needs of energy development and environmental treatment. They have been gradually applied in chemical materials, energy preparation, pollution control and other fields and have achieved impressive development.
Nucleic Acids: A Natural Target for Newly Designed Metal Chelate Based Drugs discusses how human diseases are becoming more costly to treat, along with updates on the resistance offered by disease-causing agents. The abundance of drugs in the market has provided great relief to patients, but side effects can destroy the immune system of the body. Patients need to boost their immune system, and at the same time cover expenses incurred to cure disease. Thus, a paradigm shift is needed to design a drug molecule with low cost and easy availability. Metal complexes can be a great example of such a shift, as metal ions are components of biological molecules and can achieve good binding capability to specific targets while not allowing them to damage healthy cell system. Therefore, in this book, a comprehensive compilation of recent data is provided, including the structural elucidation of metal complexes by advanced techniques and the binding pattern of metal complexes with specific targets.