How can you build the best case for a new drug application to the regulatory agencies? Preclinical studies are a crucial part in determining the pharmacokinetics of a drug – and more specifically how it is going to interact with drug transporters. So reaching out to the leading provider and consultant in this area (with strong academic roots) is the logical step at this stage of development.
Measurement of the potential of new drugs to be substrates or inhibitors of drug transporters is important in evaluating the safety of a drug in the preclinical development process, as well as to predict potential pharmacokinetic based interactions with other medicines.
Transporters have become increasingly important in drug development due to the major role they play in absorption, distribution and excretion of endogenous and exogenous compounds. The FDA & EMA emphasise the importance of evaluating new drug candidates for transporter-mediated drug-drug interactions (DDI) with a determination of substrate and inhibition potential.
Experienced Contract Research Organizations (CRO) are positioned to help ease the process for developers,