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Regulatory Roadmap for Herbal Medicines (2007)
HC USISBN: 9788190078894 bzw. 8190078895, Sprache unbekannt, Business Horizons, New Delhi, gebundenes Buch, gebraucht.
Von Händler/Antiquariat, Vedams eBooks (P) Ltd [573945], New Delhi, India.
Contents Preface. 1. Caring for health naturally. 2. Nature's pharmacy. 3. Quality taking active measures. 4. Free trade test locally and trade globally. 5. Free tree and intellectual property. 6. Pharmers and farmaceuticals. Further reading. Index. From the preface Chapter 1 attempts to provide a lay of the land and strategies to navigate through the available regulatory and market landscape through innovation and standardization. Herbal supplements are the fastest growing segment of the nutraceuticals market in the United States. A brief potpourri of herbs from different streams of traditional medicine which have become main stay in many herbal therapies and the identified active compositions are covered in chapter 2. A herbal preparation is by definition chemically complex as it contains many naturally occurring compounds of the plant or plant part. In contrast classic plant derived drugs such as atropine ephedrine quinine reserpine and scopolamine are single chemical entities. Although they are extracted from plants they are isolated and purified to make modern conventional drugs and thus cannot technically be considered for equivalent use as the plant forms. Herbs are graded in commerce and there are generally anywhere from three to five distinct grades. Herbal therapeutic formulas are often based on traditional uses of the plant species in one geographical area but commercial production often sources or grows the species somewhere else and the active contents may be different. These unregulated trading practices fuelled by the growth of the market frequently obscure the origin of the plant material and facilitate adulterations. Some of these practices with adverse consequences have damaged the reputation of otherwise relatively safe plants. Science based marketing has advantages in global market place. A key trend of globalization is the growing importance of globally acceptable quality standards. Herbal healthcare segment consists of an assortment of kitchen companies. The products manufactured by these unorganized players vary in quality and purity resulting in the end consumer receiving non standard products. The primary roadblocks to this credibility the industry currently faces are lack of product standardization and quality control and absence of documentary evidence for clinical efficacy. The first set of questions faced by every manufacturer from the regulatory agencies is about the scientific evidence that the product contains all that is claimed on the label and how does it actually work. The whole process of plant based medicines from plant to pill has to go through a phase of standardization in which there are strict quality controls throughout the value chain. Standardization is the process of analyzing a herb so that one or more of its key constituents is present in a predefined standard amount. The idea behind standardization is to ensure that each dose recommended contains consistent amount of the key ingredients that give desired and reproducible therapeutic effects. This demand could be for product registration or regulatory purposes or to satisfy customer needs about product quality and efficacy. All herbal remedies rely on evidence collected from many centuries of use by native populations but may not fit with the requisite model of randomized double blind placebo controlled trials that's considered the gold standard for western medicine. Chapter 3 focuses on discussion about good agricultural practices good manufacturing practices good laboratory practices and good clinical practices and other ISO standards such as ISO 9001 2005 and ISO 17025. Codex standards are also increasingly being used as a benchmark for global trade all medicinal plant exporting countries like India and China have increased their participation in codex committees to ensure that domestic conditions are reflected in the development of international safety standards. Chapter 4 discusses about the scientific measurement framework.
Contents Preface. 1. Caring for health naturally. 2. Nature's pharmacy. 3. Quality taking active measures. 4. Free trade test locally and trade globally. 5. Free tree and intellectual property. 6. Pharmers and farmaceuticals. Further reading. Index. From the preface Chapter 1 attempts to provide a lay of the land and strategies to navigate through the available regulatory and market landscape through innovation and standardization. Herbal supplements are the fastest growing segment of the nutraceuticals market in the United States. A brief potpourri of herbs from different streams of traditional medicine which have become main stay in many herbal therapies and the identified active compositions are covered in chapter 2. A herbal preparation is by definition chemically complex as it contains many naturally occurring compounds of the plant or plant part. In contrast classic plant derived drugs such as atropine ephedrine quinine reserpine and scopolamine are single chemical entities. Although they are extracted from plants they are isolated and purified to make modern conventional drugs and thus cannot technically be considered for equivalent use as the plant forms. Herbs are graded in commerce and there are generally anywhere from three to five distinct grades. Herbal therapeutic formulas are often based on traditional uses of the plant species in one geographical area but commercial production often sources or grows the species somewhere else and the active contents may be different. These unregulated trading practices fuelled by the growth of the market frequently obscure the origin of the plant material and facilitate adulterations. Some of these practices with adverse consequences have damaged the reputation of otherwise relatively safe plants. Science based marketing has advantages in global market place. A key trend of globalization is the growing importance of globally acceptable quality standards. Herbal healthcare segment consists of an assortment of kitchen companies. The products manufactured by these unorganized players vary in quality and purity resulting in the end consumer receiving non standard products. The primary roadblocks to this credibility the industry currently faces are lack of product standardization and quality control and absence of documentary evidence for clinical efficacy. The first set of questions faced by every manufacturer from the regulatory agencies is about the scientific evidence that the product contains all that is claimed on the label and how does it actually work. The whole process of plant based medicines from plant to pill has to go through a phase of standardization in which there are strict quality controls throughout the value chain. Standardization is the process of analyzing a herb so that one or more of its key constituents is present in a predefined standard amount. The idea behind standardization is to ensure that each dose recommended contains consistent amount of the key ingredients that give desired and reproducible therapeutic effects. This demand could be for product registration or regulatory purposes or to satisfy customer needs about product quality and efficacy. All herbal remedies rely on evidence collected from many centuries of use by native populations but may not fit with the requisite model of randomized double blind placebo controlled trials that's considered the gold standard for western medicine. Chapter 3 focuses on discussion about good agricultural practices good manufacturing practices good laboratory practices and good clinical practices and other ISO standards such as ISO 9001 2005 and ISO 17025. Codex standards are also increasingly being used as a benchmark for global trade all medicinal plant exporting countries like India and China have increased their participation in codex committees to ensure that domestic conditions are reflected in the development of international safety standards. Chapter 4 discusses about the scientific measurement framework.
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Regulatory Roadmap for Herbal Medicines
HC NWISBN: 9788190078894 bzw. 8190078895, Sprache unbekannt, Business Horizons, gebundenes Buch, neu.
Lieferung aus: Vereinigte Staaten von Amerika, शिपिंग लागत के लिए: IND.
Von Händler/Antiquariat, Cold Books.
Business Horizons . hardcover. New. pp. 182 1st Edition.
Von Händler/Antiquariat, Cold Books.
Business Horizons . hardcover. New. pp. 182 1st Edition.
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