^{2nd Middle East Pharmacy and Pharmaceutical Conference}

The therapeutic effectiveness of a drug depends upon the ability of the dosage form to deliver the medicament to its site of action at a rate and amount sufficient to elicit the desired pharmacological response. This attribute of the dosage form is referred to as physiological/ biological availability or simply as Bioavailability (BA). The expected in-vivo biological equivalence of two proprietary preparations of a drug is coined as Bioequivalence (BE). Several in-vivo and in-vitro methods are available to measure the quality of the product. The basic in-vivo bioavailability study is designed in such a manner that the formulation effect should be distinguished from other effects. Typically, a two-period, two-sequence crossover design or a parallel design is usually employed. Prior to the onset of a BA/ BE study, the study parameters such as volunteers recruitment, study dose, fixation of sampling points, moieties to be measured in the collected biological samples, pharmacokinetic parameters, Good Clinical Practice (GCP) requirements etc., needed by the pharmaceutical industry to carry out the study with the approval of the institutional ethical review board, henceforth to file the new drug application (NDA) or an abbreviated new drug application (ANDA) were assessed. A major change in the policies and procedures have occurred due to the recent harmonization in the regulatory requirements for BA/ BE studies. Selection of ideal sample preparation technique for processing the bioanalytical samples is a crucial step, as the complex matrices may seriously interfere with the quantification of the target analytes. A well-characterized and fully validated analytical methodology needs to be employed for the quantification of drugs and their metabolites in biological samples. The final report of a BA/ BE study gives the complete documentation of the above measured parameters complying with the declaration of Helsinki and GCP rules.