A Tiered Approach for the Evaluation of the Safety of Botanicals Used as Dietary Supplements: An Industry Strategy.
Clin Pharmacol Ther
; 104(3): 446-457, 2018 09.
Article
em En
| MEDLINE
| ID: mdl-29882956
ABSTRACT
Exposure to botanicals in dietary supplements is increasing across many geographies; with increased expectations from consumers, regulators, and industry stewards centered on quality and safety of these products. We present a tiered approach to assess the safety of botanicals, and an in silico decision tree to address toxicity data gaps. Tier 1 describes a Threshold of Toxicologic Concern (TTC) approach that can be used to assess the safety of conceptual levels of botanicals. Tier 2 is an approach to document a history of safe human use for botanical exposures higher than the TTC. An assessment of botanical-drug interaction (BDI) may also be necessary at this stage. Tier 3 involves botanical chemical constituent identification and safety assessment and the in silico approach as needed. Our novel approaches to identify potential hazards and establish safe human use levels for botanicals is cost and time efficient and minimizes reliance on animal testing.
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Plantas Medicinais
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Testes de Toxicidade
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Qualidade de Produtos para o Consumidor
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Suplementos Nutricionais
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Preparações de Plantas
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Indústria Farmacêutica
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Segurança do Paciente
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Fitoterapia
Idioma:
En
Ano de publicação:
2018
Tipo de documento:
Article