If the maximum safe concentration for a human is 40mg/mL, what is the equivalent I have select to perform the studies on mice? In my study I have to prove that the dose given to mice is equivalent to human dose.
I think body surface area should be considered while determining the dose of any drug in humans as well as animals. You can find attached a very good article relating your question which will definitely help you in this matter.
Regards
Please follow
1)FDA Guidance for Industry
Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers.
2)EMEA guidance
GUIDELINE ON REQUIREMENTS FOR FIRST-IN-MAN CLINICAL TRIALS FOR POTENTIAL HIGH-RISK MEDICINAL PRODUCTS
I think body surface area should be considered while determining the dose of any drug in humans as well as animals. You can find attached a very good article relating your question which will definitely help you in this matter.
Regards
As per your query - Maximum safe concentration for human is 40mg/mL , what is the equivalent I have select to perform the studies in mice...for selection of dose to perform studies in mice, one should go with LD50 value of that drug in mice than the dose is selected below it...You may find LD50 of that drug for mice in drug profile if it is available on FDA website
If I understand your question you ask how to calculate the dose to administer to animals. Generally a good starting dose can be the same dose in mg/kg that you use in men. So you have to calculate the dose in mg/kg that corresponds to 40mg/ml in men and then calculate the dose to administer based on the weight of your animal. e. g. the weight of a mouse is usually about 20 g. However since the effects of a drug in different species can be very different you should try a series of dosages and modulate the dose by increasing or decreasing it on the basis of the effect obtained with the first one
Watch out! the metabolic behaviour of some compounds are different acording to the species.
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