We have a recombinant protein which we used as a carrier for drug delivery. We wanted to do toxicology studies of the protein. As it is just a carrier but not the drug, on what basis, we can set the maximum dose?
For example, if I have an X drug which has ED50 of 10mg/kg, then I can go upto more than 100mg/kg and look for any toxicity. But I have a protein which is a carrier but not done the ED50 of the drug which is tagged to that protein. I want to use the protein itself and assess toxicity.
So my doubt is. Do I need to do know the ED50 of the drug prior to toxicity study of the formulated protein?
Should I perform the ED50 of the drug and then should I know how much dose is required to carry that ED50 of the drug and then set the maximum dose limit of the protein?
I am not looking for toxicity of the drug.
Thank you
Harsha
Dear Harsha,
Assessing toxicity is always done for a reason. "The toxicity" of a compound or ingredient cannot be described before one knows the goal of that assessment. In general, proteins are quite non-toxic. So simply testing it a t a limit dose (like 2000 mg/kg in rodents) and using internationally harmonized guidelines for choosing end points to assess is usually sufficient for that.
Some recombinant proteins have specific bioactivity. Those can be more toxic. To assess that you would first do a single dose range experiment. At a dose which seems tolerable you will do multiple dose studies. End points to monitor depend on the bioactivity of your protein otherwise you can use standard parameters as used for toxicity testing.
Al the best,
Hiskias Keizer
Thank you Dr. Keizer, Dr. Zuluaga and Ilika for your valuable information.
Your attached files are going to help me for further planning of experiment.
Regards,
Harsha
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