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Assessment of the safety and toxicity of botanical drugs in clinical trials, and in ensuring their quality once the drug is on the market, is complicated by the nature of the raw ingredients; problems arise in identifying the correct plants to harvest, in the quality of plants harvested, in their
336:
had expressed strong interest in developing botanical drugs, with more than 500 applications pending at the FDA. Part of the interest stems from a desire to address the
Chinese market, where herbal medicines remain widely used and had $ 13 billion in sales in 2011.
703:
Grady, Deborah; Sawaya, George F.; Johnson, Karen C.; Koltun, William; Hess, Rachel; Vittinghoff, Eric; Kristof, Margaret; Tagliaferri, Mary; et al. (2009). "MF101, a selective estrogen receptor β modulator for the treatment of menopausal hot flushes".
432:
Jordan SA, Cunningham DG, Marles RJ (Mar 2010). "Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment".
523:
467:
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96:; a botanical product in turn, is a finished, labeled product that contains vegetable matter as ingredients. Chemicals that are purified from plants, like
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Stovall, DW; Pinkerton, JV (2009). "MF-101, an estrogen receptor beta agonist for the treatment of vasomotor symptoms in peri- and postmenopausal women".
193:. However, toxicity testing is required before beginning larger clinical trials and trials that will be used to get approval to sell a botanical drug.
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The FDA relies on a combination of tests and controls to ensure the identity and quality of botanical drugs. The tests include "fingerprinting" using
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486:"Current regulatory toxicology perspectives on the development of herbal medicines to prescription drug products in the United States"
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U.S. Department of Health and Human
Services Food and Drug Administration, Center for Drug Evaluation and Research (CDER). June 2004.
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on raw material collection and processing. The standards are higher for botanical drugs than for extracts or plant matter used in
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must be created by the company that wants to market the drug and then approved by the FDA, after which it is published in the
315:'s chemical manufacturing and controls and Menerba was in a Phase III clinical trial as a potential treatment to relieve
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589:""Phytoestrogens in postmenopause " the state of the art from a chemical, pharmacological and regulatory perspective"
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539:"Current regulatory perspectives on genotoxicity testing for botanical drug product development in the U.S.A."
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155:(NDA) must be filed with and approved by the FDA; clinical data included in the NDA is gathered under an
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92:(FD&C) as a botanical drug that is marketed as diagnosing, mitigating, treating, or curing a
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Sinecatechins, the first botanical drug approved by the US FDA, is an extract from the leaves of
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and sell them over the counter; the US regulatory pathway is similar to that established by the
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FDA Policy And
Procedures: Office Of Pharmaceutical Science. Review Of Botanical Drug Products
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processing, and in the stability of the active components, which are often poorly understood.
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FDA Approves
Manufacturing Plan for Menerba, Bionovo's Menopausal Hot Flash Drug Candidate
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is a botanical drug candidate consisting of 22 herbs that have been used historically in
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as a botanical product that is marketed as diagnosing, mitigating, treating, or curing a
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approved as a botanical drug in the United
Kingdom as a mouth spray for people with
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The FD&C act separately regulates uses of botanical products as food (including
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If the substance being developed as a botanical drug has been used in
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The next phase:Opportunities in China's pharmaceuticals market
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A botanical drug product is defined in the United States
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approved the first botanical drug in the United States:
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Ancient
Chinese Cures Seen Helping Drugmaker Pipelines
252:(Mytesi), approved by the FDA in 2012, an extract of "
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Plant ingredients marketed for treatment of a disease
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211:The European regulatory pathway is also similar.
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200:is made up mostly of companies that make herbal
143:(OTC) or by prescription only. For OTC drugs, a
49:. Chemicals that are purified from plants, like
272:, trade name Sativex) is a specific extract of
112:, are not considered to be botanical products.
61:, are not considered to be botanical products.
421:Guidance for Industry: Botanical Drug Products
359:"Commentary: New therapies from old medicines"
139:Like other drugs, botanical drugs may be sold
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522:: CS1 maint: multiple names: authors list (
484:Wu KM, Ghantous H, Birnkrant DB (Aug 2008).
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262:plant, for diarrhea in people with HIV/AIDS
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746:Bionovo press release, September 23, 2010
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678:Current Opinion in Investigational Drugs
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796:Botanical Review Team (BRT) at the FDA
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309:selective estrogen receptor modulator
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90:Federal Food, Drug, and Cosmetic Act
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653:Statement on a nonproprietary name
311:. As of 2015 the FDA had approved
206:China Food and Drug Administration
104:, and highly purified products of
53:, and highly purified products of
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357:Chen ST; et al. (Oct 2008).
665:Sativex (nabiximols) - factsheet
37:is defined in the United States
587:Poluzzi E; et al. (2014).
537:Wu KM; et al. (Feb 2010).
198:Chinese pharmaceutical industry
282:, who can use it to alleviate
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202:traditional chinese medicines
718:10.1097/gme.0b013e31818e64dd
605:10.2174/09298673113206660297
305:traditional Chinese medicine
151:. For prescription drugs, a
66:Food and Drug Administration
554:10.1016/j.yrtph.2009.09.012
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446:10.1016/j.taap.2009.12.005
762:Page accessed May 2, 2015
640:What is a Botanical Drug?
502:10.1016/j.fct.2008.05.029
228:bark with a few drops of
157:Investigational New Drug
816:Pharmaceutical industry
760:Menerba page at Bionovo
542:Regul Toxicol Pharmacol
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106:industrial fermentation
55:industrial fermentation
434:Toxicol Appl Pharmacol
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378:10.1038/nbt1008-1077
187:traditional medicine
153:New Drug Application
180:dietary supplements
117:dietary supplements
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292:overactive bladder
280:multiple sclerosis
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191:toxicology testing
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59:biopharmaceuticals
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64:In 2006 the
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317:hot flashes
102:artemisinin
805:Categories
548:(1): 1–3.
341:References
288:spasticity
266:Nabiximols
250:Crofelemer
135:Regulation
98:paclitaxel
84:Definition
51:paclitaxel
758:Bionovo.
706:Menopause
394:205271440
321:menopause
145:monograph
129:cosmetics
734:31985236
726:19182698
690:19337958
623:24164197
562:19782117
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275:Cannabis
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313:Bionovo
301:Menerba
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722:PMID
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558:PMID
524:link
506:PMID
468:link
450:PMID
382:PMID
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