Dedicated PK Trials in Patients

That kind of PK trials in patients is usually conducted to investigate whether the PK in patients is comparable to that in healthy subjects. Any differences in the pharmacokinetics of the investigational compound between patients and healthy subjects may either be caused by the pathophysiology of the disease, for example, in case of inflammation, or the metabolism or excretion of the study drug may be influenced by hepatic or renal impairment which is not the situation in healthy subjects. Inamed’s clinical personnel is experienced in the conduct of such PK trials, and our clinical pharmacology experts will stand at your disposal, if you need scientific advice as to the need of such a trial or regarding the design elements of a planned study. Whether a planned PK trial in patients can be conducted at Inamed’s own clinical facilities under highly standardized conditions or in cooperation with hospitals and clinical specialists depends on the patient population to be recruited.