Botanicals as “new” drugs: US development
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- 作者：Freddie Ann Hoffman ; fhoffman@heterogeneity-LLC.com" class="auth_mail" title="E-mail the corresponding author
- 关键词：Botanical ; Regulation ; Investigational New Drug ; IND ; New Drug Application ; NDA ; New drug approval ; Drug development ; Food and Drug Administration
- 刊名：Epilepsy & Behavior
- 出版年：2015
- 出版时间：November 2015
- 年：2015
- 卷：52
- 期：part_PB
- 页码：338-343
- 全文大小：401 K
文摘
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Future treatments for seizure disorders may include complex botanicals.
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An overview of how the United States regulates products is presented.
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Claims to “treat” or “prevent” seizures require premarket approval in the US.
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As drugs, botanicals have unique characteristics.
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The pathway to US drug approval for botanicals is discussed.