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  • rd389 replied to the topic Failure's of Pre-Clinical / Clinical Research in the forum Pre-clinical Device Development 7 years, 7 months ago

    1. Why was a need to overdose animals?
    2. What measures were taken to avoid future overdosing to animals?
    3. How were the dead animals disposed?
    4. Any care was taken during disposing, considering bio hazards?

    Sorry to reply to you guys (@ppp23 @scott) so late. So, I deal with the samples that are taken from these monkeys or other animals, plasma/blood and check the dosage of drug and how much amount worked the max at what time using different extraction method. As far as what I have heard through my superiors, this is one of the common problem because sometimes monkeys/rats/beagles cannot take that much amount of dosage and they die. These animals are usually tested and screened, but at the end of they day there are no guarantees given. I am truly not sure of disposal of animal but I am sure they have to follow the rules and regulations according to FDA. These are big pharmaceutical companies so they can not just dispose the dead animals in a garbage.