Drug metabolism comprises the identification, characterization, and quantification of the chemicals or compounds produced in an animal or human upon administration of a drug. Research practices not only require the chemical structure but also aim to determine the pharmacological activities and/or toxicity of these compounds. This is first performed in animals, as studies attempt to identify and quantify metabolites, and later in humans, with care to further characterize metabolites that are either unique to or produced disproportionately in humans compared to animals. Characterization includes the determination of enzyme systems or other biological mechanisms that produce each identified metabolite; this information is used to predict potential drug-drug interactions with other compounds that increase or decrease metabolite formation and sources of biological variability in response or toxicity with varying patient genetics, which affect CYP isoform expression. This book’s purpose is to provide some understanding of the biology and current technology applied in the field of drug metabolism.

Handbook of Lung Targeted Drug Delivery Systems: Recent Trends and Clinical Evidences covers every aspect of the drug delivery to lungs, the physiology and pharmacology of the lung, modelling for lung delivery, drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications. With the advent of nano sciences and significant development in the nano particulate drug delivery systems there has been a renewed interest in the lung as an absorption surface for various drugs. The emergence of the COVID-19 virus has brought lung and lung delivery systems into focus, this book covers new developments and research used to address the prevention and treatment of respiratory diseases. Written by well-known scientists with years of experience in the field this timely handbook is an excellent reference book for the scientists and industry professionals. Key Features: Focuses particularly on the chemistry, clinical pharmacology, and biological developments in this field of research. Presents comprehensive information on emerging nanotechnology applications in diagnosing and treating pulmonary diseases Explores drug devices focused on lung treatment, regulatory requirements, and recent trends in clinical applications Examines specific formulations targeted to pulmonary systems

First published in 2007, Lies, Damned Lies, and Drug War Statistics critically analyzed claims made by the Office of National Drug Control Policy (ONDCP), the White House agency of accountability in the nation's drug war since 1989, as found in the six editions of the annual National Drug Control Strategy between 2000 and 2005. In this revised and updated second edition of their critically acclaimed work, Matthew B. Robinson and Renee G. Scherlen examine seven more recent editions (2006–2012) to once again determine if ONDCP accurately and honestly presents information or intentionally distorts evidence to justify continuing the drug war. They uncover the many ways in which ONDCP manipulates statistics and visually presents that information to the public. Their analysis demonstrates a drug war that consistently fails to reduce drug use, drug fatalities, or illnesses associated with drug use; fails to provide treatment for drug-dependent users; and drives up the prices of drugs. They conclude with policy recommendations for reforming ONDCP's use of statistics, as well as how the nation fights the war on drugs.

The vast majority of drugs are organic molecular entities. A clear understanding of the organic chemistry of drug degradation is essential to maintaining the stability, efficacy, and safety of a drug product throughout its shelf-life. During analytical method development, stability testing, and pharmaceutical manufacturing troubleshooting activities, one of the frequently occurring and usually challenging events would be the identification of drug degradants and understanding of drug degradation mechanisms and pathways. This book is written by a veteran of the pharmaceutical industry who has first-hand experience in drug design and development, drug degradation mechanism studies, analytical development, and manufacturing process troubleshooting and improvement. The author discusses various degradation pathways with an emphasis on the mechanisms of the underlying organic chemistry, which should aid greatly in the efforts of degradant identification, formulation development, analytical development, and manufacturing process improvement. Organic reactions that are significant in drug degradation will first be reviewed and then illustrated by examples of drug degradation reported in the literature. The author brings the book to a close with a final chapter dedicated to the strategy for rapid elucidation of drug degradants with regard to the current regulatory requirements and guidelines. One chapter that should be given special attention is Chapter 3, Oxidative Degradation. Oxidative degradation is one of the most common degradation pathways but perhaps the most complex one. This chapter employs more than sixty drug degradation case studies with in-depth discussion in regard to their unique degradation pathways. With the increasing regulatory requirements on the quality and safety of pharmaceutical products, in particular with regard to drug impurities and degradants, the book will be an invaluable resource for pharmaceutical and analytical scientists who engage in formulation development, analytical development, stability studies, degradant identification, and support of manufacturing process improvement. In addition, it will also be helpful to scientists engaged in drug discovery and development as well as in drug metabolism studies.

JENTADUETO XR Drug Profile, 2023

This report focuses on JENTADUETO XR and covers the following critical aspects of this drug:

• United States patents
• Expired United States patents
• FDA Paragraph IV patent challenges
• District Court patent litigation
• Patent Trial and Appeal Board (PTAB) patent cases
• European supplementary protection certificates (SPCs)
• Clinical trials
• Drug prices
• Finished product suppliers
• Raw active pharmaceutical ingredient (API) sources

Towards a better understanding of how medicines are used in society Drug Utilization Research (DUR) is a discipline which combines aspects of pharmacotherapy, epidemiology, and health services research into an interdisciplinary set of methods for analyzing and assessing the prescribing, dispensing and consumption of medicines. It combines both qualitative and quantitative approaches to facilitate the safe and effective use of pharmaceuticals. Drug Utilization Research: Methods and Applications provides a comprehensive introduction to this discipline, prepared by an international team of authors with broad experience in numerous fields. Now reorganized and updated to reflect the latest research and global challenges, it is an indispensable resource for understanding the use of pharmaceuticals. Readers of the second edition of Drug Utilization Research will find: New chapters on methods, including more hands-on guidance on how to plan and conduct different types of drug utilization A section on specific applications in areas such as psychotropics, opioids, cancer drugs, antibacterials, and cardiovascular drugs A new section with case studies illustrating applications of DUR in different continents Detailed treatment of subjects including DUR and health policy, DUR in specific populations, and many more Drug Utilization Research is ideal for epidemiologists, pharmacists, physicians, nurses and others interested in drug use and its outcomes.

This practical reference for medicinal and pharmaceutical chemists combines the theoretical background with modern methods as well as applications from recent lead finding and optimization projects. Divided into two parts on the thermodynamics and kinetics of drug-receptor interaction, the text provides the conceptual and methodological basis for characterizing binding mechanisms for drugs and other bioactive molecules. It covers all currently used methods, from experimental approaches, such as ITC or SPR, right up to the latest computational methods. Case studies of real-life lead or drug development projects are also included so readers can apply the methods learned to their own projects. Finally, the benefits of a thorough binding mode analysis for any drug development project are summarized in an outlook chapter written by the editors.

Introducing the book "Novel Drug Delivery System" is something that fills me with an incredible amount of joy. The content of this book has been meticulously crafted to adhere to the curriculum for Bachelor of Pharmacy students that has been outlined by the Pharmacy Council of India. An effort has been made to investigate the topic using terminology that is as straightforward as possible in order to make it more simply digestible for pupils. The book has a number of illustrations, such as flowcharts and diagrams that make it simple for students to comprehend complex ideas. It is the author's honest desire that both students and academicians would take something helpful away from reading this book. The formulation development process is built upon the foundation of the pharmaceutical product development process. During the development of the product, the formulation scientist is responsible for paying attention to several parameters connected to the material (API, Excipients, and so on), the formulation process, the parameters of the formulation process, dosage forms, and so on. In this book, a variety of formulation development-related topics, including those pertaining to dosage, are broken down in a way that is clear and easy to grasp.

This text book is a guide for pharmaceutical academics (students and teachers) as well as industry professionals learning about drug delivery and formulation. Chapters presents comprehensive information about self-emulsifying formulations by providing an in-depth understanding of the basic concepts and formulation mechanisms. This information is supplemented by details about current research and development in this field. Readers will learn about the types of self-emulsifying drug delivery systems, evaluation parameters and digestion models, among other topics. Key Features: - 9 chapters organized in a reader-friendly layout - complete guide on self-emulsifying drug delivery formulations, including lipid based systems, SMEDOs, surfactants, and oral dosage forms - includes basic concepts and current developments in research and industrial applications - presents information on conventional and herbal formulations - references for further reading