Hello. Hope you're having a good day.
According to ISO-10993 guidelines, systemic toxicity testing should be done with extracts of the medical device. We are trying to develop a novel hemostatic dressing/ scaffold. I cannot find any information regarding the dose of the extracts that need to be administered to the animals during the toxicity study. Any and all suggestions are welcome. Thanks in advance!
Dear Sayantan,
In general, you can refer to the OECD guidelines for testing of chemicals. For single dose toxicity testing there ids an upper limit of 2000 mg/kg, for repeated dose testing 1000 mg/kg/day.
Best regards
Thomas
Thanks Thomas Hofmann !
I have referred to the OECD Guidelines too. All the guidelines state an upper limit on the dosage, but no guidelines mention any method to decide the minimum/initial dosage. Should the LD50 data from cytotoxicity studies be used to estimate minimum dose? If so, then how to calculate from LD50?
Dear Sayantan,
You can perform a pre-study with a low number of animals, e.g. 2. Usually, since it is an extract, systemic toxicity is low, thus you can start with 2000 mg/kg.
The correlation of cytotoxicity data with the oral LD50 is not good.
Best regards
Thomas
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