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Botanical Drug Products
Botanicals, which have been part of human food and medicine for thousands of years, are perceived as being safer than synthetic pharmaceuticals. The global botanical drug market was expected to reach $26.6 billion by 2017. In terms of FDA regulations, botanical drugs are no different from non-botanical products, having to meet the safety and effectiveness standards of a new drug in accordance. This book comprises a complete start-to-end process from drug-idea conception, to drug development process. Key Features: Provides a complete compendium for botanical drug products Describes what BDP is and how it differs from Pharma, Biopharma, and Nutraceuticals Compiles all critical regulatory steps in a variety of countries Discusses clinical trial management for BDP development and how it differs from conventional chemical-based drugs and biopharmaceutics
Botanical Drugs
Herbal medicines have a long history of practice and hold great promise for treating human diseases. However, the traditional formula suffers many limitations that impede the fulfillment of their potential. There is, thus, a great need to transform traditional herbal medicines into Food and Drug Administration (FDA) approved modern botanical drugs. The current regulation of herbal medicines in the United States fails to provide sufficient incentives for the American drug industry to develop botanical drugs from herbal medicines. To provide such an incentive, this paper argues that the FDA should take into account the unique history and characteristics of herbal medicines, and adopt a special approval guideline for botanical drugs developed from these medicines. Such a guideline will facilitate the mainstreaming of herbal medicines in the United States, and at the same time alleviate the production crisis facing the American pharmaceutical industry. The paper then evaluates the recent FDA's Draft Guidance for Botanical Drug Products for its incentive effects on the industry and makes specific recommendations for the final version of the Guidance.
Botanical Leads for Drug Discovery
Active botanical ingredients are a prime requirement for herbal formulations and discovering a drug is all about integration of science disciplines. In recent decades there has been a growing interest in treating wounds and diseases using traditional remedies based on local herbs, combined with chemical advances. Although this has led to the development of new bioactive ingredients from plants, there has been little success in terms of clinical trials and post-marketing studies to comply with FDA guidelines. Plants have been used as a source of medicine throughout history and continue to serve as the basis for many pharmaceuticals used today. However, despite the modern pharmaceutical indust...
Drug Discovery and Traditional Chinese Medicine
The "First International Conference on Traditional Chinese Medicine: Science, Regulation and Globalization" was held from August 30 to September 2, 2000 at the University of Maryland at College Park, Maryland. There were approximately 250 participants from the Peoples Republic of China, Taiwan, Hong Kong and the United States. This objective of this conference was to promote international collaboration for the modernization of Traditional Chinese herbal medicines (TCM) and their introduction into the global health care system. It was mainly sponsored by the Ministry of Science and Technology of the People's Republic of China and the NllI National Center for Complementary and Alternative Medi...
Modern Medicines from Plants
The full colour, beautifully illustrated Modern Medicines from Plants: Botanical histories of some of modern medicine’s most important drugs features information on plants from which we obtain modern prescription medicines. It outlines their historical uses as herbal medicines in the past two millennia, using primary sources, and describes how extracts from them, and their semisynthetic and synthetic derivatives, were developed to be today’s therapeutic drugs and diagnostic chemicals. This book describes medicinal plants and their habitats, the diseases that their medicines treat, and the science of how they work. This amazing and unique book is a wonderful read for those with an interes...
Drug Discovery & Development
While biotechnological advances, genomics and high throughput screenings or combinatorial and asymmetric syntheses are opening new opportunities in drug discovery, the industry is facing serious innovation deficit. The total number of new molecules registered per year has dropped in contrast to expected increase. Post marketing failures of blockbuster drugs have become major concerns of industries. On the other side, globally there is a major shift to sue of traditional medicine involving complementary and alternative therapies. Ethnopharmacology and traditional medicines have contributed in past significantly in the process of natural product drug discovery. There are two clear tracks where...
Ethnobotany and the Search for New Drugs
A compilation of articles by prominent experts in their respective fields on compensation for and collaboration with indigenous people in regard to their knowledge and provision of rare plants which are used for some of the most potent drugs in Western medicine.
