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We don't need more animal data".
Once early research shows that the technique can be safe, and more animal data are available on possible effects in later generations, regulators could consider loosening that restriction.
These first findings are promising; however more animal data with more time points to evaluate scaffold degradation and bone formation is needed including the comparison with existing bone substitutes.
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While data from carcasses are useful for determining relative tissue distributions and estimating amounts of toxin necessary to cause mortality, samples from live animals provide more accurate animal data (i.e., toxin levels, blood parameters, age class, sex, etc). in conjunction with environmental (i.e., HAB species, fish collections) and spatiotemporal data.
Finally, there are also clear parallels with a far more extensive animal data set, and so, altogether, this diverse data set indicates a consistent association of particular characteristic features defining the ictal core and the ictal penumbral territories.
Neither company has yet filed for licensure and both are continuing to collect more human and animal data to support their applications for approval.
Hence, designing animal experiments with the aid of computer modeling may reduce the number of animal experiments and allow a more reliable extrapolation of animal data to humans.
Therefore, the design of animal experiments in consideration of calculated data based on species-specific kinetic values may lead to a more reliable extrapolation of animal data to humans and may reduce the number of necessary animal experiments.
This will provide more scientific merit that animal data can be used as sentinels for predicting human risk, and hopefully promote the need for public health informatics surveillance systems to automatically integrate the animal and human data.
Before we go on to provide a detailed response, we are listing below a summary of all of the major inclusions in the revised manuscript: 1) Data acquired from two more animals (our overall data set now stands at 4 males and 4 females) 2) Performed additional analysis to determine optimal response windows for modulation of auditory cortex neurons by ultrasonic vocalizations.
Biological plausibility needs to be demonstrated with supportive animal data from more than one species and using more than one model of disease that needs to be both representative of the human condition and with appropriate timing of the intervention.
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