Bücher von M. Jhansi Lakshmi

Bioavailability is defined as the amount of drug concentration is present in the blood or systemic circulation. Bioequivalence is defined as the comparison between two formulations that are test and reference. Basically bioequivalence studies are conducted to know the pharmacokinetic parameters of the drug. BE studies are conducted on already proven medications which are altered or modified. Such type of drugs need not to undergo clinical trials, BE studies are sufficient to know their safety and efficacy. BE studies are done on healthy subjects only in exception of cytotoxic drugs. I did my study on Esomeprazole magnesium delayed release capsules USP 40 mg in 12 healthy humans under fed conditions for two periods. All subjects completed the study without any adverse events. Both test and reference formulations were tolerated by dosed subjects. This molecule is used to treat gastric problems. We estimate the pharmacokinetic information regarding both test and reference formulations.