Solution
In general, fasting condition is considered to be the most sensitive condition to detect a potential difference between two formulations, however again this is not the thumb rule. There are several factors which also needs to be considered before deciding if fasting or fed study condition is more appropriate or if both studies are recommended by agency. These factors include product solubility, physio-chemical characteristics, effect on food on solubility, site of absorption, type of formulation, product variability, metabolism and pharmacokinetic properties including gastric emptying, gastrointestinal pH, luminal metabolism etc. We had practically seen that agency has accepted single study if strong supportive evidences based on pilot data or literature are provided. At Pharmadesk such conditions comes multiple time and taking decisions based on above factors helps essentially to save thousand of dollar.
