Disproportionality analysis of buprenorphine transdermal system and cardiac arrhythmia using FDA and WHO postmarketing reporting system data.

Objective: Positive-controlled clinical studies have shown a dose dependent effect of buprenorphine transdermal system on QTc interval prolongation. This study provides assessment of the buprenorphine transdermal system and cardiac arrhythmia using US FDA and WHO postmarketing reporting databases.

Methods: Disproportionality analysis of spontaneously reported adverse events to assess whether the reporting rate of cardiac arrhythmia events was disproportionately elevated relative to expected rates of reporting in both FDA and WHO databases.

Enfuvirtide plasma levels and injection site reactions using a needle-free gas-powered injection system (Biojector).

Objectives: To assess the use of the Biojector B2000 needle-free gas-powered injection system for subcutaneous administration of enfuvirtide in HIV-infected patients and to compare this system with standard needles and syringes with respect to ease of use, severity of injection site reactions (ISR), and enfuvirtide plasma levels.

Design: An observational study among 32 treatment-experienced HIV clinic patients receiving enfuvirtide.

Methods: Adult patients were assessed before and after switching from standard needles to the Biojector for enfuvirtide administration.

Studies on the use of needle-free injection device on proteins.

In the following communication we report the evaluation of 18 proteins that were processed by a specific needle free injection device. The processed protein samples were analyzed by two HPLC techniques, reversed-phase liquid chromatography (RPLC) and size-exclusion chromatography (SEC). These techniques are two of the most widely used analytical techniques in the biopharmaceutical industry for the characterization, integrity assessment and stability study of peptide and protein products.