The Science And Regulations Of Naturally Derived Complex Drugs

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The Science and Regulations of Naturally Derived Complex Drugs

Author : Ram Sasisekharan
Publisher : Springer
ISBN 13 : 3030117510
Total Pages : 331 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis The Science and Regulations of Naturally Derived Complex Drugs by : Ram Sasisekharan

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.

Non-Biological Complex Drugs

Author : Daan J.A. Crommelin
Publisher : Springer
ISBN 13 : 3319162411
Total Pages : 390 pages
Book Rating : 4.3/5 (191 download)

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Book Synopsis Non-Biological Complex Drugs by : Daan J.A. Crommelin

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.

Non-Biological Complex Drugs

Author : Daan J.A. Crommelin
Publisher : Springer
ISBN 13 : 9783319162409
Total Pages : 0 pages
Book Rating : 4.1/5 (624 download)

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Book Synopsis Non-Biological Complex Drugs by : Daan J.A. Crommelin

Download or read book Non-Biological Complex Drugs written by Daan J.A. Crommelin and published by Springer. This book was released on 2015-07-09 with total page 0 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.

Herbal Medicine

Author : Iris F. F. Benzie
Publisher : CRC Press
ISBN 13 : 1439807167
Total Pages : 500 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Herbal Medicine by : Iris F. F. Benzie

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

Nutrition Biophysics

Author : Thomas A. Vilgis
Publisher : Springer Nature
ISBN 13 : 3662675978
Total Pages : 471 pages
Book Rating : 4.6/5 (626 download)

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Book Synopsis Nutrition Biophysics by : Thomas A. Vilgis

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.

Modern Methods of Clinical Investigation

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309042860
Total Pages : 241 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Modern Methods of Clinical Investigation by : Institute of Medicine

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.

Official Gazette of the United States Patent and Trademark Office

Author :
Publisher :
ISBN 13 :
Total Pages : 380 pages
Book Rating : 4.0/5 ( download)

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Book Synopsis Official Gazette of the United States Patent and Trademark Office by :

Download or read book Official Gazette of the United States Patent and Trademark Office written by and published by . This book was released on 1993 with total page 380 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Health Effects of Cannabis and Cannabinoids

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309453070
Total Pages : 487 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Health Effects of Cannabis and Cannabinoids by : National Academies of Sciences, Engineering, and Medicine

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.

Organic Chemistry of Drug Degradation

Author : Min Li
Publisher : Royal Society of Chemistry
ISBN 13 : 1849734216
Total Pages : 311 pages
Book Rating : 4.8/5 (497 download)

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Book Synopsis Organic Chemistry of Drug Degradation by : Min Li

Download or read book Organic Chemistry of Drug Degradation written by Min Li and published by Royal Society of Chemistry. This book was released on 2012 with total page 311 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book examines drug degradation pathways with an emphasis on the underlying chemical mechanisms.

Interactions Between Proteins and Biomacromolecules: Tools and Applications

Author : Qunye Zhang
Publisher : Frontiers Media SA
ISBN 13 : 2889711218
Total Pages : 137 pages
Book Rating : 4.8/5 (897 download)

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Book Synopsis Interactions Between Proteins and Biomacromolecules: Tools and Applications by : Qunye Zhang

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:

Plants Go to War

Author : Judith Sumner
Publisher : McFarland
ISBN 13 : 1476676127
Total Pages : 367 pages
Book Rating : 4.4/5 (766 download)

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Book Synopsis Plants Go to War by : Judith Sumner

Download or read book Plants Go to War written by Judith Sumner and published by McFarland. This book was released on 2019-06-03 with total page 367 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the first botanical history of World War II, Plants Go to War examines military history from the perspective of plant science. From victory gardens to drugs, timber, rubber, and fibers, plants supplied materials with key roles in victory. Vegetables provided the wartime diet both in North America and Europe, where vitamin-rich carrots, cabbages, and potatoes nourished millions. Chicle and cacao provided the chewing gum and chocolate bars in military rations. In England and Germany, herbs replaced pharmaceutical drugs; feverbark was in demand to treat malaria, and penicillin culture used a growth medium made from corn. Rubber was needed for gas masks and barrage balloons, while cotton and hemp provided clothing, canvas, and rope. Timber was used to manufacture Mosquito bombers, and wood gasification and coal replaced petroleum in European vehicles. Lebensraum, the Nazi desire for agricultural land, drove Germans eastward; troops weaponized conifers with shell bursts that caused splintering. Ironically, the Nazis condemned non-native plants, but adopted useful Asian soybeans and Mediterranean herbs. Jungle warfare and camouflage required botanical knowledge, and survival manuals detailed edible plants on Pacific islands. Botanical gardens relocated valuable specimens to safe areas, and while remote locations provided opportunities for field botany, Trees surviving in Hiroshima and Nagasaki live as a symbol of rebirth after vast destruction.

The Role of Natural Products in Drug Discovery

Author : J. Mulzer
Publisher : Springer Science & Business Media
ISBN 13 : 3662040425
Total Pages : 363 pages
Book Rating : 4.6/5 (62 download)

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Book Synopsis The Role of Natural Products in Drug Discovery by : J. Mulzer

Download or read book The Role of Natural Products in Drug Discovery written by J. Mulzer and published by Springer Science & Business Media. This book was released on 2013-04-17 with total page 363 pages. Available in PDF, EPUB and Kindle. Book excerpt: Natural Products have been important sources of useful drugs from prehistoric times to the present. This book gives an overview about this field and provides important recent contributions to the discovery of new drugs generated by research on natural products. Total synthesis of natural products with interesting biological activities is paving the way for the preparation of new and improved analogs. The methods of combinatorial chemistry permit the selection of the best drug from a large number of candidates. Beyond synthesis and evaluation of organic molecules a number of new bioorganic methods are coming to the fore and will be discucced in this isue of the ERnst schering Research Foundation workshop proceedings.

Network Pharmacology

Author : Shao Li
Publisher : Springer Nature
ISBN 13 : 9811607532
Total Pages : 480 pages
Book Rating : 4.8/5 (116 download)

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Book Synopsis Network Pharmacology by : Shao Li

Download or read book Network Pharmacology written by Shao Li and published by Springer Nature. This book was released on 2021-09-29 with total page 480 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book introduces “network pharmacology” as an emerging frontier subject of systematic drug research in the era of artificial intelligence and big data. Network Pharmacology is an original subject of fusion system biology, bioinformatics, network science and other related disciplines. It emphasizes on starting from the overall perspective of the system level and biological networks, the analysis of the laws of molecular association between drugs and their treatment objects, reveals the systematic pharmacological mechanisms of drugs, and guides the research and development of new drugs and clinical diagnosis and treatment. After it was proposed, network pharmacology has been paid attention by researchers, and it has been rapidly developed and widely used. In order to systematically reveal the biological basis of diagnosis and treatment in traditional Chinese medicine and modern medicine, we proposed a new concept of "network target" for the first time, which has become the core theory of "network pharmacology". The core principle of a network target is to construct a biological network that can be used to decipher complex diseases. The network is then used as the therapeutic target, to which multicomponent remedies are applied. This book mainly includes four parts: 1) The concept and theory of network pharmacology; 2) Common analysis methods, databases and software in network pharmacological research; 3) Typical cases of traditional Chinese medicine modernization and modern drug research based on network pharmacology; 4) Network pharmacology practice process based on drugs and diseases.

Natural Polysaccharides in Drug Delivery and Biomedical Applications

Author : Md Saquib Hasnain
Publisher : Academic Press
ISBN 13 : 0128170565
Total Pages : 654 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis Natural Polysaccharides in Drug Delivery and Biomedical Applications by : Md Saquib Hasnain

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

Biodiversity

Author : National Academy of Sciences/Smithsonian Institution
Publisher : National Academies Press
ISBN 13 : 0309037395
Total Pages : 535 pages
Book Rating : 4.3/5 (9 download)

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Book Synopsis Biodiversity by : National Academy of Sciences/Smithsonian Institution

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.

Understanding Body Shapes of Animals

Author : Holger Preuschoft
Publisher : Springer Nature
ISBN 13 : 3030276686
Total Pages : 587 pages
Book Rating : 4.0/5 (32 download)

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Book Synopsis Understanding Body Shapes of Animals by : Holger Preuschoft

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".

Alkaloids

Author : Joanna Kurek
Publisher : BoD – Books on Demand
ISBN 13 : 1789845769
Total Pages : 102 pages
Book Rating : 4.7/5 (898 download)

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Book Synopsis Alkaloids by : Joanna Kurek

Download or read book Alkaloids written by Joanna Kurek and published by BoD – Books on Demand. This book was released on 2019-11-13 with total page 102 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Alkaloids" is intended for by chemistry, biochemistry, pharmacy, and other medical students, biologists, chemists, biochemists, and other professionals involved in the field of alkaloids. All chapters in this book are written by professionals in the areas of alkaloid chemistry, biology, pharmacy, and other interesting applications. The chapters cover interesting and less obvious information about different groups of alkaloids.