Abstract

COMPARING GENERIC AND INNOVATOR DRUGS: A REVIEW OF COMPARISON OF BIOEQUIVALENCE DATA OF HYDROCORTISONE CONVENTIONAL TABLET AND HYDROCORTISONE MODIFIED RELEASE TABLET

Manish Mudaliar* Dr Dilip Maheshwari

ABSTRACT

In patients taking Plenadren (Hydrocortisone Modified Release) the cortisol levels achieved were considered to be satisfactory for patients with adrenal insufficiency. The overall amount of cortisol absorbed into the blood was around 20% lower in patients taking Plenadren compared with patients taking conventional hydrocortisone treatment. Moreover generic drug of Plenadren is cost effective treatment and serve as a gold standard therapy. Most nations require generic drug manufacturers to prove that their formulation exhibits bioequivalence to the innovator product. A generic product is considered to be bioequivalent to the pioneer product if the 90% confidence interval (CI) of the mean AUC and the relative mean Cmax is 80% to 125%. This criterion is the same standard used for testing the bioequivalence of branded products with reformulation or manufacturing changes.

Keywords: Generic drug, q.d or o.d (once in day), t.i.d (thrice in day), Plenadren (Modified Release Dosage form)