Download or read book The Science and Regulations of Naturally Derived Complex Drugs written by Ram Sasisekharan and published by Springer. This book was released on 2019-04-23 with total page 331 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume in the AAPS Advances series covers various quality, safety and clinical aspects of drug development that are relevant to new and/or generic drugs containing a complex mixture of molecules. Specific topics discussed include: raw materials sourcing; manufacturing controls; characterization; identification of critical product quality components and attributes; identification of impurities, particularly as they bear on toxicity and immunogenicity; clinical trial study design considerations, and the regulatory science applications to development of such complex mixtures. Complex mixtures are challenging to characterize and analyze using standard methods. Further challenges extend throughout the product development cycle from raw material control to clinical study design. The regulatory landscape is rapidly changing as new types of complex mixtures are introduced into clinical trials and to the market (e.g., traditional Chinese medicines and medical marijuana products), while older products are facing generic competition for the first time (e.g., enoxaparin). The future outlook for complex generic drug products, as opposed to the more commonly developed targeted single agent drug products is not clear. The risks pertaining to lack of a full understanding of raw material control, process and controls in manufacture, as well as characterization of a complex mixture were seen vividly during the heparin crisis of 2008. As such powerful lessons have been learned about the regulatory science specific to complex products. The Science and Regulations of Naturally Derived Complex Drugs addresses the interests among industry, academics, and government on the issues surrounding the future development of mixtures for medicinal use.
Download or read book Non Biological Complex Drugs written by Daan J.A. Crommelin and published by Springer. This book was released on 2015-06-24 with total page 390 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rise of bio- and nano-technology in the last decades has led to the emergence of a new and unique type of medicine known as non-biological complex drugs (NBCDs). This book illustrates the challenges associated with NBCD development, as well as the complexity of assessing the effects of manufacturing changes on innovator and follow-on batches of NBCDs. It also touches upon proven marketing authorization requirements for biosimilars that could be effective in evaluating follow-on NBCDs, including a demonstration of control over the manufacturing process and a need for detailed physico-chemical characterization and (pre)clinical tests. This book is meant to be used for years to come as a standard reference work for the development of NBCDs. Moreover, this book aims to stimulate discussions and further our thinking to ensure that decisions regarding the approval of complex drugs are made with relevant scientific data on the table.
Download or read book Traditional Medicines in Drug Discovery and Development written by Varughese George and published by Cambridge Scholars Publishing. This book was released on 2024-07-18 with total page 693 pages. Available in PDF, EPUB and Kindle. Book excerpt: This comprehensive book, comprising 20 chapters contributed by respected academics in their respective fields, highlights the immense contribution of traditional medicine to the discovery and development of modern drugs. Each chapter provides in-depth details, stimulating experts to further explore the flora used in traditional medicines and inspiring younger investigators to delve into the mysterious world of secondary metabolites in their quest for novel molecules. This book is of immense value to scientists, academicians, researchers, and students alike, making it a valuable addition to personal collections and libraries.
Download or read book Herbal Medicine written by Iris F. F. Benzie and published by CRC Press. This book was released on 2011-03-28 with total page 500 pages. Available in PDF, EPUB and Kindle. Book excerpt: The global popularity of herbal supplements and the promise they hold in treating various disease states has caused an unprecedented interest in understanding the molecular basis of the biological activity of traditional remedies. Herbal Medicine: Biomolecular and Clinical Aspects focuses on presenting current scientific evidence of biomolecular ef
Download or read book Nutrition Biophysics written by Thomas A. Vilgis and published by Springer Nature. This book was released on 2023-09-07 with total page 471 pages. Available in PDF, EPUB and Kindle. Book excerpt: Do you no longer understand the countless, contradictory dietary recommendations? Do you find it difficult to distinguish between good and bad when it comes to cholesterol? Are you torn between the various dietary rules and nutritional forms that come your way every day and despair of the term "healthy diet"? Or are you confronted professionally, e.g. as a consultant or fitness coach, with questions on the subject of nutrition and would like to learn the scientific basics? The author Thomas Vilgis advises you to remain calm and to think objectively about all assumptions, presumptions, promises and suggestions for orientation. This book leads you off the beaten track and with a scientific, sober view to fundamental questions of nutrition. Starting with the nutritional history of Homo sapiens, the author guides you into the fundamental interplay between proteins, fats, and carbohydrates, what they do in the body, how they are digested, and what role they really play. Supporting you will find in the second edition various retrievable videos in which complex relationships are clearly explained. This quickly shows how little is hidden behind some dubious statements. With the claim of a scientific and molecular view of nutrition, it is possible to put into perspective and classify many a questionable recommendation on nutrition in an understandable and entertaining way.
Download or read book Marijuana As Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 2000-12-30 with total page 216 pages. Available in PDF, EPUB and Kindle. Book excerpt: Some people suffer from chronic, debilitating disorders for which no conventional treatment brings relief. Can marijuana ease their symptoms? Would it be breaking the law to turn to marijuana as a medication? There are few sources of objective, scientifically sound advice for people in this situation. Most books about marijuana and medicine attempt to promote the views of advocates or opponents. To fill the gap between these extremes, authors Alison Mack and Janet Joy have extracted critical findings from a recent Institute of Medicine study on this important issue, interpreting them for a general audience. Marijuana As Medicine? provides patientsâ€"as well as the people who care for themâ€"with a foundation for making decisions about their own health care. This empowering volume examines several key points, including: Whether marijuana can relieve a variety of symptoms, including pain, muscle spasticity, nausea, and appetite loss. The dangers of smoking marijuana, as well as the effects of its active chemical components on the immune system and on psychological health. The potential use of marijuana-based medications on symptoms of AIDS, cancer, multiple sclerosis, and several other specific disorders, in comparison with existing treatments. Marijuana As Medicine? introduces readers to the active compounds in marijuana. These include the principal ingredient in Marinol, a legal medication. The authors also discuss the prospects for developing other drugs derived from marijuana's active ingredients. In addition to providing an up-to-date review of the science behind the medical marijuana debate, Mack and Joy also answer common questions about the legal status of marijuana, explaining the conflict between state and federal law regarding its medical use. Intended primarily as an aid to patients and caregivers, this book objectively presents critical information so that it can be used to make responsible health care decisions. Marijuana As Medicine? will also be a valuable resource for policymakers, health care providers, patient counselors, medical faculty and studentsâ€"in short, anyone who wants to learn more about this important issue.
Download or read book Modern Methods of Clinical Investigation written by Institute of Medicine and published by National Academies Press. This book was released on 1990-02-01 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: The very rapid pace of advances in biomedical research promises us a wide range of new drugs, medical devices, and clinical procedures. The extent to which these discoveries will benefit the public, however, depends in large part on the methods we choose for developing and testing them. Modern Methods of Clinical Investigation focuses on strategies for clinical evaluation and their role in uncovering the actual benefits and risks of medical innovation. Essays explore differences in our current systems for evaluating drugs, medical devices, and clinical procedures; health insurance databases as a tool for assessing treatment outcomes; the role of the medical profession, the Food and Drug Administration, and industry in stimulating the use of evaluative methods; and more. This book will be of special interest to policymakers, regulators, executives in the medical industry, clinical researchers, and physicians.
Download or read book Marijuana and Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-10 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: The medical use of marijuana is surrounded by a cloud of social, political, and religious controversy, which obscures the facts that should be considered in the debate. This book summarizes what we know about marijuana from evidence-based medicineâ€"the harm it may do and the relief it may bring to patients. The book helps the reader understand not only what science has to say about medical marijuana but also the logic behind the scientific conclusions. Marijuana and Medicine addresses the science base and the therapeutic effects of marijuana use for medical conditions such as glaucoma and multiple sclerosis. It covers marijuana's mechanism of action, acute and chronic effects on health and behavior, potential adverse effects, efficacy of different delivery systems, analysis of the data about marijuana as a gateway drug, and the prospects for developing cannabinoid drugs. The book evaluates how well marijuana meets accepted standards for medicine and considers the conclusions of other blue-ribbon panels. Full of useful facts, this volume will be important to anyone interested in informed debate about the medical use of marijuana: advocates and opponents as well as policymakers, regulators, and health care providers.
Download or read book Drug Discovery and Development written by Ramarao Poduri and published by Springer Nature. This book was released on 2021-02-15 with total page 522 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes the processes that are involved in the development of new drugs. The authors discuss the history, role of natural products and concept of receptor interactions with regard to the initial stages of drug discovery. In a single, highly readable volume, it outlines the basics of pharmacological screening, drug target identification, and genetics involved in early drug discovery. The final chapters introduce readers to stem therapeutics, pharmacokinetics, pharmacovigilance, and toxicological testing. Given its scope, the book will enable research scholars, professionals and young scientists to understand the key fundamentals of drug discovery, including stereochemistry, pharmacokinetics, clinical trials, statistics and toxicology.
Download or read book Interactions Between Proteins and Biomacromolecules Tools and Applications written by Qunye Zhang and published by Frontiers Media SA. This book was released on 2021-08-02 with total page 137 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Health Effects of Cannabis and Cannabinoids written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-31 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.
Download or read book WHO Global Report on Traditional and Complementary Medicine 2019 written by World Health Organization and published by World Health Organization. This book was released on 2019-05-16 with total page 228 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report is structured in five parts: national framework for traditional and complementary medicine (T&CM); product regulation; practices and practitioners; the challenges faced by countries; and finally the country profiles. Apart from the section on practices and practitioners the report is consistent with the format of the report of the first global survey in order to provide a useful comparison. The section on practices and practitioners which covers providers education and health insurance is a new section incorporated to reflect the emerging trends in T&CM and to gather new information regarding these topics at a national level. All new information received has been incorporated into individual country profiles and data graphs. The report captures the three phases of progress made by Member States; that is before and after the first WHO Traditional Medicine Strategy (1999?2005) from the first global survey to the second global survey (2005?2012) and from the second survey to the most recent timeline (2012?2018).
Download or read book Understanding Body Shapes of Animals written by Holger Preuschoft and published by Springer Nature. This book was released on 2022-06-28 with total page 587 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses how and why animals evolved into particular shapes. The book identifies the physical laws which decide over the evolutionary (selective) value of body shape and morphological characters. Comparing the mechanical necessities with morphological details, the author attempts to understand how evolution works, and which sorts of limitations are set by selection. The book explains morphological traits in more biomechanical detail without getting lost in physics, or in methods. Most emphasis is placed on the proximate question, namely the identification of the mechanical stresses which must be sustained by the respective body parts, when they move the body or its parts against resistance. In the first part of the book the focus is on ‘primitive’ animals and later on the emphasis shifts to highly specialized mammals. Readers will learn more about living and fossil animals. A section of the book is dedicated to human evolution but not to produce another evolutionary tree, nor to refine a former one, but to contribute to answering the question: “WHY early humans have developed their particular body shape".
Download or read book Toxicokinetics written by and published by . This book was released on 1995 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Natural Polysaccharides in Drug Delivery and Biomedical Applications written by Md Saquib Hasnain and published by Academic Press. This book was released on 2019-07-23 with total page 654 pages. Available in PDF, EPUB and Kindle. Book excerpt: Natural Polysaccharides in Drug Delivery and Biomedical Applications provides a fundamental overview of natural polysaccharides, their sources, extraction methodologies, and characterizations. It covers specific natural polysaccharides and their effective application in drug delivery and biomedical use. Additionally, chapters in the book discuss key topics including the sources and extraction methodologies of natural polysaccharides, their role in tissue engineering applications, polysaccharide-based nanoparticles in biomedical applications, and their role in the delivery of anticancer drugs. Written by industry leaders and edited by experts, this book emphasizes recent advances made in the field. Natural Polysaccharides in Drug Delivery and Biomedical Applications provides academics, researchers, and pharmaceutical health care professionals with a comprehensive book on polysaccharides in pharmaceutical delivery process. Provides fundamental concepts of natural polysaccharides as it applies to the pharmaceutical, biomedical, and biotechnology industries Includes contributions from global leaders and experts from academia, industry, and regulatory agencies in the application of natural polysaccharides in pharmaceutical products and biomedical utilization Offers practical examples, illustrations, chemical structures, and research case studies to help explain natural polysaccharides concepts in drug delivery and biomedical applications
Download or read book Natural Small Molecule Drugs from Plants written by Guan-Hua Du and published by Springer. This book was released on 2018-11-19 with total page 741 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book discusses 120 types of natural, small-molecule drugs derived from plants. They are grouped into 7 parts according their clinical uses, such as drugs for cardiovascular diseases, for metabolic diseases, for neuropsychiatric diseases, for immune-mediated inflammatory diseases, anti-tumor drugs, and drugs for parasites and bacterial infection. Each chapter systematically summarizes one drug, including its physicochemical properties, sources, pharmacological effects and clinical applications. To help readers understand the drug better, the research and pharmacological activity for each drug is also described, which serves as a salutary lesson for future drug development. Written by frontline researchers, teachers and clinicians working in field of pharmacy and pharmacology it provides an overview of natural, small-molecule drugs derived from plants for researchers in the field.
Download or read book Biodiversity written by National Academy of Sciences/Smithsonian Institution and published by National Academies Press. This book was released on 1988-01-01 with total page 535 pages. Available in PDF, EPUB and Kindle. Book excerpt: This important book for scientists and nonscientists alike calls attention to a most urgent global problem: the rapidly accelerating loss of plant and animal species to increasing human population pressure and the demands of economic development. Based on a major conference sponsored by the National Academy of Sciences and the Smithsonian Institution, Biodiversity creates a systematic framework for analyzing the problem and searching for possible solutions.
