What are the scientific justifications for using the proposed endpoint?
Scientific justification for a proposed endpoint is related to the goals of the project. Firstly, the work must have scientific merit. Secondly, the endpoint must fulfill the scientific requirements. For example, in a neurotoxicological study, it could be important to identify damage to the nerve cells, in which case the endpoint could be set at a point that indicated that damage had occurred, determined by pilot studies. The experiment would have fulfilled its scientific objectives once this point had been reached and would not require progression to an extreme indication of neuronal damage, such as loss of righting reflex. Scientific justification should not rest wholly on comparison with published data, as this does not permit refinement of endpoints. A pilot study could be suggested to compare a new scientifically justifiable endpoint with data from a previous study using the older, later endpoint. What is the expected time course for the animals, from the initial treatment to firs
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