How to do bioequivalence studies in animals from human formulation (tablets)?

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M S Muthu

You can not extrapolate the animal data to human data for bioequivalence. However, you can do in vitro studies (e.g., dissolution etc) that can predict the bioequivalence performance for human, particularly for tablets. Bioequivalence means making the formulations equal at clinical level for human use.

Additionally, research has no limit. Academic research I found people breaking the tablet and giving to rabbit and check for cmax, tmax, AUC by calculating plasma drug conc. Will it useful for further study or match with human data?

If you want to develop the product for veterinary (animal) use, sumalatha answer is very correct. You mean for human use then please refer for procedure in standard guideline or >3 impact factor having journal. They wont recommend it.

http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004304.pdf

Attached a European guideline for Bio equivalence study of veterinary products.

Srinivas Pottella

thanking you very much sir @ M S Muthu

Dear sir/madam how to prepare the standard calibration curve for plasma samples to know the drug concentration in plasma by using UV Visible spectroscopy methods.please guide me dear all

HPLC will be only option. If you dont have HPLC then extract the drug from plasma by using organic solvent and evaporate it. Store it. Send the dry matter to a place where you get HPLC for payment basis.