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EMA-approved biosimilars
Published in Sarfaraz K. Niazi, Biosimilars and Interchangeable Biologics, 2016
Standard heparin is known to cause adverse reactions called immunogenic responses, such as heparin-induced thrombocytopenia (HIT). LMWH is made from standard heparin but is associated with a lower rate of HIT than standard heparin. The FDA expects sponsors of generic enoxaparin products to demonstrate that their manufactured versions do not have any higher risk of these or other dangerous reactions than Lovenox. Although conducting immunogenicity testing for this product can be an extensive and time-consuming process for a manufacturer, all manufacturers of generic enoxaparin are expected to do this as part of the application process. These studies evaluated impurities using physiochemical and biological assays.
Device profile of the Impella 5.0 and 5.5 system for mechanical circulatory support for patients with cardiogenic shock: overview of its safety and efficacy
Published in Expert Review of Medical Devices, 2022
Mohit Pahuja, Jaime Hernandez-Montfort, Evan H. Whitehead, Masashi Kawabori, Navin K. Kapur
Impella device involves blood to flow continuously into the catheter, hence, a purge solution flows runs retrograde to the blood flow that creates a pressure barrier and prevents blood entry into the motor. It also requires heparin which helps to maintain adequate purge pressure by preventing thrombotic complications. Currently the manufacturer recommends titrating heparin to maintain the goal activated clotting time (ACT) of 160–180. Many patients require non-purge systemic heparin to maintain this target but, in some patients, purge heparin solution may be sufficient to maintain the therapeutic targets. If the patients is running higher targets with only the purge solution, it is recommended to reducing the heparin to half concentration. In patients with heparin-induced thrombocytopenia, a direct thrombin inhibitor such as bivalirudin or argatroban can by given separately outside the purge solution [45].
Classifying unevenly spaced clinical time series data using forecast error approximation based bottom-up (FeAB) segmented time delay neural network
Published in Computer Methods in Biomechanics and Biomedical Engineering: Imaging & Visualization, 2021
Y. Nancy Jane, H. Khanna Nehemiah, Arputharaj Kannan
Batal et al. (2009) have proposed a segmented time series feature (STF) mine algorithm that extracts the discriminative temporal abstraction patterns from frequent temporal patterns obtained using qualitative temporal abstraction mechanism and Allen’s temporal relations (Allen, 1983). The multivariate features obtained were used to learn a classification model. The algorithm had improved the classification accuracy and was experimented with a real heparin-induced thrombocytopenia dataset. Temporal abstraction is considered as a method of representing point-based time series data as interval-based summarised descriptions. Batal et al. (2013) have investigated the effectiveness of temporal abstraction in discovering knowledge from time series.
Diagnosis, treatment & management of prosthetic valve thrombosis: the key considerations
Published in Expert Review of Medical Devices, 2020
Sabahattin Gündüz, Macit Kalçık, Mustafa Ozan Gürsoy, Ahmet Güner, Mehmet Özkan
PHVT remains a life-threatening complication after valve replacement surgery. Subtherapeutic anticoagulation remains the key driving force for the development of PHVT. However, cardiologists should be cognizant of other frequent or rare conventional and esoteric causes. These include, but not limited to, heparin-induced thrombocytopenia, elevated lipoprotein (a) levels, presence of ATA, elevated heparanase levels, increased neutrophil to lymphocyte ratio, hypereosinophilia, inherited causes, AB0 blood types, elevated serum fibrinogen levels. Moreover, measurement of baseline ATA and heparanase levels before TT is initiated can provide implications regarding the lytic success and reoccurrence of thrombosis.