**3.1 Australia**

The Therapeutics Goods Administration (TGA) considers two formulations to be bioequivalent if the ratios between the two formulations of Cmax and AUC should lie in the range of 0.80–1.25 and Tmax should also be similar between the two formulations [25]. There are closer limits for drugs with a narrow therapeutic index and saturable metabolism. Thus, no generic drug formulations exist in for digoxin or phenytoin for instance in the Australian market.
