Botanical drugs evidence

NDI status is granted by the BRT (Section 6.2, Botanical Drug Products) when the team does not contest the application submitted by the advocating commercial or private interest. The application must contain evidence ensuring the safety of the NDI. Typically two thirds of the applications are rejected due to unresolved safety and identity issues. The burden of proof of reasonable safety of the NDI falls directly on the applicant. Unfortunately, applicants typically provide only anecdotal safety information. Typically, it is based on folkloric or traditional uses and does not include appropriate or relevant clinical data. 

Overview of Chemistry, Manufacturing, and Control Evidence Needed to Support Clinical Trials for Botanical Drugs... 

However, the information derived from a detailed pharmacokinetic study will help to anticipate potential botanical product-drug interactions, to optimize the bioavailability, the quality, and hence the efficacy of herbal medicines, to support evidence for the synergistic nature of herbal medicines, and to better appreciate the safety and toxicity of the plant. Because pharmacokinetic studies with herbal medicines are often complicated by their chemical complexity and by the fact that the active compounds are often unknown, it could be one future issue to assess bioavailability by measuring surrogate parameters in plasma or tissue instead of directly assaying putative active compounds in the blood. In summary, to use HMPs in an evidence-based approach and to achieve the status rational phytomedicine, more experimental studies are needed to characterize the bioavailability and pharmacokinetics of botanical products. 

This chapter provides an evidence-based approach to the pharmacology and clinical efficacy of several of the commonly used and commercially available botanicals and dietary supplements. Ephedrine, the active principle in Ma-huang, is discussed in Chapter 9 Adrenoceptor-Activating Other Sympathomimetic Drugs. 

Natural medicinals are available without prescription and are considered to be nutritional supplements rather than drugs. Herbal (botanic) products are marketed without FDA review of safety and efficacy, and there are no requirements governing the purity or the chemical identities of constituents. Evidence supporting the clinical effectiveness of herbal products is commonly incomplete. 

A dietary supplement is a product that is intended to supplement the diet and contains at least one or more of certain dietary ingredients, such as a vitamin, mineral, herb or other botanical, or an amino acid. These products may not be represented as conventional foods rather, they are marketed in forms that include capsules, tablets, gelcaps, soft-gels, and powders. Although manufacturers must have evidence to support their claims of a dietary supplement s safety and efficacy, US Food and Drug Administration (FDA) approval is not required before a product is marketed. Micronutrient dietary supplements (vitamins and minerals for purposes of this discussion) are commonly pm-chased and consumed in developed cormtries, even... 

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