Novel erythropoiesis stimulating protein (NESP) for the treatment of anaemia of chronic disease associated with cancer

Anaemia is a common haematologic disorder in patients with cancer and has a multifactorial aetiology, including the effects of the malignancy itself and residual effects from previous therapy. Novel erythropoiesis stimulating protein (NESP, darbepoetin alfa), a protein with additional sialic acid compared with erythropoietin (EPO), stimulates erythropoiesis by the same mechanism as recombinant human erythropoietin (rHuEPO) but it is biochemically distinct. NESP, with its approximately 3-fold greater serum half-life, can maintain haemoglobin levels as effectively as rHuEPO in anaemic patients with chronic renal failure and do so with less frequent dosing. We investigated the ability of NESP to safely increase haemoglobin levels of anaemic patients with non-myeloid malignancies not receiving chemotherapy. NESP was administered under the supervision of a physician at doses of 0.5, 1.0, 2.25 or 4.5 mcg kg−1wk−1for a maximum of 12 weeks. This report includes 89 patients completing the study by November 2000. NESP was well tolerated, with no reported dose-limiting toxicities or treatment-related severe adverse events. Increasing doses of NESP corresponded with increased efficacy. The percentage (95% confidence interval) of patients responding ranged from 61% (42%, 77%) in the 1.0 mcg kg−1wk−1group to 83% (65%, 94%) in the 4.5 mcg kg−1wk−1group. © 2001 Cance Cancer Research Campaig

Scene analysis and organization of behavior in driver assistance systems

To reduce the number of traffic accidents and to increase the drivers comfort, the thought of designing driver assistance systems arose in the past years. Fully or partly autonomously guided vehicles, particularly for road traffic, pose high demands on the development of reliable algorithms. Principal problems are caused by having a moving observer in predominantly natural environments. At the Institut fur Neuroinformatik methods for analyzing driving relevant scenes by computer vision are developed in cooperation with several partners from the automobile industry. We present a solution for a driver assistance system. We concentrate on the aspects of video-based scene analysis and organization of behavior

Analysis of complex drugs by comprehensive two-dimensional gas chromatography and high-resolution mass spectrometry: Detailed chemical description of the active pharmaceutical ingredient sodium bituminosulfonate and its process intermediates.

The European pharmacopeia provides analytical methods for the chemical characterization of active pharmaceutical ingredients (APIs). However, the complexity of some APIs exceeds the limitations of the currently prevailing physicochemical methods. Sodium bituminosulfonate (SBS) is described by the collection of key parameters of generalizing criteria such as dry matter, sulfur and sodium content, and neutrality, but techniques to unravel the complexity on a molecular level are lacking. We present a study based on online derivatization with tetramethylammonium hydroxide in combination with comprehensive two-dimensional gas chromatography coupled to an electron ionization high-resolution time-of-flight mass spectrometer (GC × GC-HR-ToF–MS) for the chemical description of SBS as well as its process intermediates. The application of GC × GC allowed the comprehensive description of the chemical components in the API and the process intermediates for the first time. Furthermore, it was possible to classify peaks regarding their elemental and structural composition based on accurate mass information, elution behavior, and mass fragmentation pattern. This work demonstrates not only the general applicability, advantages but also limitations of GC × GC for the characterization of APIs for complex drugs. Graphical Abstract: [Figure not available: see fulltext.