Benchmark dose for a veterinary product

Client

An animal-health product-development consultancy.

Background

The client was interested in mitigating the problem of a genotoxic metabolite identified in a farm animal following the topical application of a new drug.

Project goals

To calculate a benchmark dose (BMD) for the metabolite, for use by the client in the calculation of a margin of exposure as part of the risk assessment process.

Approach

Bibra was provided with a published report describing a feeding study in rats in which a dose-dependent incidence of malignant tumours had been identified. The data were entered into the US Environmental Protection Agency’s BMDS calculator, selecting a suitable benchmark response and the relevant dichotomous mathematical models. For each model, a BMD and its corresponding lower confidence interval (the BMDL10) was calculated. The outcomes of the various models were considered, taking into account the goodness-of-fit, and the viable alternatives were compared.

Project outcome

The lowest BMDL10 was presented in the report, this being the most health-precautionary value.

Bibra project team

Anne Edwards
James Hopkins

 

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