Last month, the ICH launched a draft on Drug Interaction Studies regulatory. The guideline includes the regulations of the European, American and Japanese medical agencies and covers both in vitro and clinical studies.
It is well known that food intake changes luminal conditions (e.g. pH, motility, microbiota,…) in the stomach and the small intestine, modifying drugs bioavailability. Food-drug interactions are one of the major challenges for oral-administered drugs, even more so if considering the growing use of food supplements and functional foods.
The endothelial cells that conform the BBB limit the passage of blood circulating endogenous substrates and larger molecules to the brain. This intrinsic protective role is also a major hurdle for reasearchers developing drugs for Central Nervous System (CNS) disorders.
Specialized manufacturer of in vitro kits indicated to evaluate pharmacological relevant efflux and uptake receptors for TDI assays.
Transmembrane efflux receptors, Pgp, MRP1 and BCRP has shown a relevant effect in the chemoterapy resistance.