Regulation of research: Is it a drug trial or a supplement trial?

Chen, Shaw T.

doi:10.1016/j.fitote.2010.11.011

Cited by 5 publications

(2 citation statements)

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“…For traditional Chinese medicines, the latter requirement would be extremely problematic. The FDA is considering revising its regulations to allow for the exemption of botanical drugs, such as PHY906, under certain circumstances (Chen et al, 2008;Chen, 2011).…”

Section: Fda Regulatory Requirementsmentioning

confidence: 99%

Old formula, new Rx: The journey of PHY906 as cancer adjuvant therapy

Liu

Cheng

2012

Journal of Ethnopharmacology

136

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Section: Fda Regulatory Requirementsmentioning

confidence: 99%

Old formula, new Rx: The journey of PHY906 as cancer adjuvant therapy

Liu

Cheng

2012

Journal of Ethnopharmacology

136

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“…Dietary supplements include vitamins, minerals, herbs, amino acids, and enzymes. Dietary supplements are not intended for the treatment, diagnosis, prevention or cure of diseases ( 42 ). Unlike pharmaceutical products, which must be proven safe and effective by regulatory authorities before marketing, manufacturers, and distributors of dietary supplements are solely responsible for ensuring that their products are safe before entering the market.…”

Section: Introductionmentioning

confidence: 99%

Glaucoma Clinical Research: Trends in Treatment Strategies and Drug Development

et al. 2021

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Purpose: To investigate the trends and progresses in glaucoma research by searching two major clinical trial registries; clinicaltrials.gov, and Australianclinicaltrials.gov.au.Methods: All clinical trials with glaucoma covered by Clinicaltrials.gov, and Australianclinicaltrials.gov.au starting the study before 1 January 2021 were included. Trials evaluating glaucoma treatment were separated from non-treatment trials and divided into three major categories: “laser treatment,” “surgical treatment,” and “medical treatment.” In the category of “medical treatment,” new compounds and their individual targets were identified and subcategorized according to treatment strategy; intraocular pressure (IOP)-lowering, neuroprotective or vascular. The phase transition success rates were calculated.Results: One-thousand five hundred and thirty-seven trials were identified. Sixty-three percent (n = 971) evaluated glaucoma treatment, of which medical treatment accounted for the largest proportion (53%). The majority of medical trials evaluated IOP-lowering compounds, while trials with neuroprotective or vascular compounds accounted for only 5 and 3%, respectively. Eighty-eight new compounds were identified. Phase I, II, and III transition success rates were 63, 26, and 47%, respectively.Conclusion: The number of clinical trials in glaucoma research has increased significantly over the last 30 years. Among the most recently evaluated compounds, all three main treatment strategies were represented, but clinical trials in neuroprotection and vascular modalities are still sparse. In addition to traditional medicines, dietary supplements and growth factors are assessed for a potential anti-glaucomatous effect. Phase II and III success rates were below previously reported success rates for all diseases and ophthalmology in general. A stricter phenotyping of patients can improve the success rates in glaucoma and ophthalmological research and gain a better understanding of responders and non-responders.

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Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations

Dou¹,

Beitz²

2019

The Science and Regulations of Naturally Derived Complex Drugs

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Regulation of research: Is it a drug trial or a supplement trial?

Cited by 5 publications

References 0 publications

Old formula, new Rx: The journey of PHY906 as cancer adjuvant therapy

Old formula, new Rx: The journey of PHY906 as cancer adjuvant therapy

Glaucoma Clinical Research: Trends in Treatment Strategies and Drug Development

Development of Plant-Derived Mixtures as Botanical Drugs: Clinical Considerations

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