Phase I comparability of recombinant human albumin and human serum albumin.

Recombinant human albumin (rHA) is a highly purified animal-, virus-, and prion-free product developed as an alternative to human serum albumin (HSA), to which it is structurally equivalent. The present investigation compared the safety, tolerability, and pharmacokinetics/pharmacodynamics of rHA with HSA. Two double-blind, randomized trials were performed in healthy volunteers using intramuscular (IM) and intravenous (IV) administration.

Continuous intravenous infusion of a plasma-derived factor IX concentrate (Mononine) in haemophilia B.

This prospective, multicentre, open-label study evaluated the efficacy and safety of a plasma-derived factor IX concentrate [Mononine, Coagulation Factor IX (Human) Monoclonal Antibody Purified] administered by continuous intravenous (CIV) infusion to patients with haemophilia B. Admission criteria included documented diagnosis of haemophilia B (mild, moderate, or severe). Twenty-eight patients (25 surgery, two trauma, one severe spontaneous haemorrhage) were enrolled to receive a therapeutic bolus dose followed by CIV infusion of factor IX (FIX) to maintain FIX:C plasma levels of 0.

Caring for the critically ill patient. High-dose antithrombin III in severe sepsis: a randomized controlled trial.

Context: Activation of the coagulation system and depletion of endogenous anticoagulants are frequently found in patients with severe sepsis and septic shock. Diffuse microthrombus formation may induce organ dysfunction and lead to excess mortality in septic shock. Antithrombin III may provide protection from multiorgan failure and improve survival in severely ill patients.

Consideration of endogenous backgrounds in pharmacokinetic analyses: a simulation study.

Objective: The pharmacokinetic analysis of biologic compounds is frequently disturbed by the presence of endogenous levels, which cannot be discerned from exogenous levels. The frequently used method of subtracting baseline levels from subsequent measurements was compared to a fully adjusted regression model in a simulation study.

Methods: Simulations (5,000 each) were carried out for a standard one-compartment model with rich (n = 10) and poor (n = 6) postdose sampling, using unweighted as well as two-weighted types of non-linear regression.