Clinical pharmacology studies, such as ADME, drug-drug interaction (DDI) and renal/hepatic impairment pharmacokinetic (PK) studies can provide important data to support new drug applications (NDAs). While ADME and DDI studies typically enroll healthy volunteer participants, renal/hepatic impairment PK studies require patients, which often adds a degree of complexity to the study design and conduct.

Celerion understands the unique nature of renal and hepatic insufficiency patient populations and manages these specialized PK studies to efficiently and effectively complete your studies on time and with excellent quality data through our extensive US-EU site network. Please see below a wealth of resources that highlight our experience and expertise managing renal/hepatic impairment PK studies.