· Genotoxic and non-genotoxic activity. Direct and indirect mechanisms
· DNA and non-DNA targets.
· Criteria for the definition of positive, statistical significance fold increases, relationships to historical databases of control and treated values
· Assay reproducibility. False positives and negatives.
· Dose response relationships, exponential and threshold models, factors which may include a threshold, nucleoside analogues, aneugens, topoisomerase inhibitors, detoxification, repair etc.
· Influence of toxicity, acute and chronic toxicity, high and low toxicities.
· The development of optimal designs. Quality control, the activity of IWGT and the criteria for test system validation.
· Operation of regulatory bodies
· Strategies for testing as illustrated by national and international requirements.
· Examples of data, with interpretation problems. Clear, equivocal and inconclusive data sets, single and multiple assays
· Test batteries and the problems of conflicting data, weight of evidence considerations.
· Potency measurements using in vitro and in vivo tests, potential for human risk estimation.
· Artefacts in the in vitro and in vivo assays. False positive and negative.
· Biological relevance of responses in vitro and in vivo, influence of species specific metabolism, S9 modifications
· Interactive workshops evaluating test data.