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NC3Rs: National Centre for the Replacement Refinement & Reduction of Animals in Research
Guidance

Exposure and dose selection

Introduction

Better consideration of exposure within toxicological testing is necessary to ensure that the data generated are relevant to answer the scientific questions being asked. For example, measurement of internal test compound concentrations (toxicokinetics) can aid in dose setting for toxicology studies to ensure that doses causing overt toxicity are not used in test animals. Also, a greater understanding of exposure within new approach methodology test systems will support the translation of effects to in vivo situations - making these data more useful for decision-making purposes, and ultimately reducing the current reliance on data from animal tests.

Applying exposure science to increase the utility of non-animal data in efficacy and safety testing

Bringing together experts in the fields of exposure science, efficacy and toxicology to increase the uptake of non-animal approaches.

Publication: The current status of exposure-driven approaches for chemical safety assessment: A cross-sector perspective

2017 workshop report: Applying exposure science to increase the utility of non-animal data in efficacy and safety testing.

You can read more about this project on our project page: Applying exposure science to increase the utility of non-animal data in efficacy and safety testing.

Refining MTD studies

An industry collaboration to provide evidence to define the upper limit of body weight loss in rat, dog and non-human primate maximum tolerated dose (MTD) studies.

You can read more about this project on our project page: Refining MTD studies

Pharmacokinetics in candidate selection

Reducing the number of animals use in the prediction of human pharmacokinetics (PK).

Publication: Human clearance prediction: shifting the paradigm

Publication: Towards an integrated human clearance prediction strategy that minimizes animal use

You can read more about this project on our project page: Pharmacokinetics in candidate selection.

Toxicokinetics in the chemicals industry

Increasing the use of toxicokinetics in the evaluation of non-pharmaceutical chemicals.

Publication: Application of toxicokinetics to improve chemical risk assessment: Implications for the use of animals

Publication: Use of toxicokinetics to support chemical evaluation: Informing high dose selection and study interpretation

You can read more about this project on our project page: Toxicokinetics in the chemicals industry.

Keep up to date with the latest news from the NC3Rs Toxicology and Regulatory Sciences programme.