Research by Germany-based biotech company PharmaInformatic compared study results on drug-uptake (oral bioavailability) in animals and humans for a wide range of approved and established drugs has claimed that sole reliance on drug-uptake in animal trials can be misleading.
Results demonstrated that oral bioavailability in animals is not in line with the values reported for humans. For instance, Aripiprazole and Esomeprazole, which are the most sold drugs in 2013, possess low oral bioavailability in animals, while it is high in humans.
Most successful commercial drugs such as blockbuster treatments also showed large difference in the values, which are said to have annual sales of around $1bn.
During the drug development process, most of the compounds are usually tested on rats, dogs, monkeys and mice to test for the effectiveness and possession of sufficient oral bioavailability. Further drug development is put on hold if the bioavailability is too low.
According to PharmaInformatic, animal trials on drug-uptakes are mostly replaced by an alternative system such as IMPACT-F, which is used to evaluate human oral bioavailability in different therapeutic areas such as diabetes, inflammation, antivirals, autoimmune diseases and cancer. The system is said to evaluate oral bioavailability more efficiently in humans, compared to animal trials.
It is expected to increase the prospects of human clinical trials, as the optimum oral dose for first-in-human clinical trials can be determined much more accurately.