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2019 North American ISSX Symposium
Potential Benefits of a Physiologically-Revelant Whole Cell Model
to Assess CYP Inhibition with Complex Mixtures

Amy Roe, PhD, DABT, Principal Toxicologist, Product Safety & Regulatory Affairs, The Procter and Gamble Company presented the results from a published study (Roe et. al., 2019 AIVT), at the 2019 North American ISSX show, to evaluate potential inhibition of CYP3A4/5 and CYP2C9 enzymatic activity by Boswellia serrata extract (BSE) using pooled human liver microsomes (PHLM) and a more physiologically-relevant sandwich-cultured human hepatocytes (SCHH) model.

In the scientific literature, BSE has been shown to reduce the activity (55% to 65%) across major CYP450 enzymes, including CYP3A4/5 and CYP2C9, using baculovirus-infected insect cells. These reported results, contrasted with a seemingly history of safe use of BSE, led us to question the relevance of the PHLM model. We will show that potent CYP3A4/5 and CYP2C9 inhibition observed for BSE in microsomal systems was not observed in SCHH. SCHH are particularly useful for studying complex mixtures such as botanicals and are an effective model to evaluate BDI and DDI.

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Amy Roe

Amy Roe, PhD, DABT
Principal Toxicologist, Product Safety & Regulatory Affairs
The Procter and Gamble Company

Dr. Roe has over 20 years of experience as a practicing toxicologist in government, pharmaceutical, and consumer product industries, through positions at both the U.S. FDA (NCTR) and The Procter & Gamble Company. Her expertise includes drug/ xenobiotic metabolism and pharmacokinetics and she has led toxicology programs in support of drugs, medical devices, herbal &dietary supplements, foods and water filtration devices.

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