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Title: How similar is similar enough? A sufficient similarity case study with Ginkgo

Author
item RIDER, CYNTHIA - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item CATLIN, NATASHA - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item COLLINS, BRADLEY - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item AUERBACH, SCOTT - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item FERGUSON, STEPHEN - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item WAIDYANATHA,, SURAMYA - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item SMITH-ROE, STEPHANIE - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item WITTA, KRISTINE - National Institute Of Environmental Health Sciences (NIEHS, NIH)
item Harnly, James - Jim
item GENNINGS, CHRIS - Mount Sinai Hospital
item RICE, GLENN - Us Environmental Protection Agency (EPA)

Submitted to: Food and Chemical Toxicology
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 7/11/2018
Publication Date: 7/11/2018
Citation: Rider, C.V., Catlin, N.R., Collins, B.J., Auerbach, S.S., Ferguson, S.S., Waidyanatha,, S., Smith-Roe, S.L., Witta, .L., Harnly, J.M., Gennings, C., Rice, G. 2018. How similar is similar enough? A sufficient similarity case study with Ginkgo. Food and Chemical Toxicology. 118:328-339.

Interpretive Summary: A general framework for determining sufficient similarity is described using Ginkgo biloba extracts (GBE) as a case study. Botanical dietary supplements, such as GBE, are ideally suited for exploring the issues surrounding sufficient similarity of complex mixtures because they involve both widespread, relatively high human exposure and pressing public health questions about quality and safety. The components of the case study will be described first, followed by examples of the application of sufficient similarity methods using data generated at the National Toxicology Program. Detailed methods and results for each of the data streams used in the examples are beyond the scope of this summary and will be published separately. Instead, this paper addresses the process of evaluating sufficient similarity, which could potentially be applied to other complex mixtures using any number of chemical and biological-response data streams. The goals of this work are to develop and evaluate methods for determining chemical and biological-response similarity.

Technical Abstract: A general framework for determining sufficient similarity is described using Ginkgo biloba extracts (GBE) as a case study. Botanical dietary supplements, such as GBE, are ideally suited for exploring the issues surrounding sufficient similarity of complex mixtures because they involve both widespread, relatively high human exposure and pressing public health questions about quality and safety. The components of the case study will be described first, followed by examples of the application of sufficient similarity methods using data generated at the National Toxicology Program. Detailed methods and results for each of the data streams used in the examples are beyond the scope of this summary and will be published separately. Instead, this paper addresses the process of evaluating sufficient similarity, which could potentially be applied to other complex mixtures using any number of chemical and biological-response data streams. The goals of this work are to develop and evaluate methods for determining chemical and biological-response similarity.