Pharmacokinetic (PK) Trials

The clinical facilities and infrastructure of Inamed’s clinical unit are appropriately staffed and equipped to conduct all kind of pharmacokinetic (PK) trials. Dedicated laboratory facilities, temperature-controlled working rooms, refrigerators and deep freezers connected with alarm systems and an emergency power generator are also available. Some special PK trials such as absolute or relative bioavailability (BA) trials and bioequivalence (BE) trials require not only the adherence to accurate operational procedures, but also special knowledge of current guidance documents and regulatory requirements regarding the work environment and some special procedures (e.g., handling of retention samples). The assessment of bioequivalence of inhaled drugs is a very special topic. The qualified staff at Inamed has extensive expertise in this area and is looking back on more than 15 years of experience in conducting those trials.