Uji Bioavailabilitas dan Bioekivalensi Obat : Urgensi dan Pedoman Pelaksanaannya

Abstract

Number of "me too drugs" circulating in Indonesia may provide a different effictiveness because of differences in bioavailability due to differences in formulation and production process of the pharmaceutical industry. Bioavailability and bioequivalency test needs to be done to ensure the quality and effictivity of drugs. Testing is done by comparing the levels of "me too drugs" and innovator drugs" in the blood / urine test subjects. Pharmacokinetic parameters of blood data that useful in determining the bioavailability are time to peak concentration (tmax), peak concentration (Cmax) and area under the curve (AUC) For determination using urine data, some parameters are the number of cumulative drug excreted in urine (Du), the rate of drug excretion in the urine (dDu/dt) and time of maximum excretion of drugs. Two medicinal products are bioequivalent if they are pharmaceutically equivalent and f their bioavailabilities after administration in the same molar dose are similar to such a degree that their fficts, with respect to both fficacy and safety, will be essentially the same