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Yet another embodiment of the present invention includes a method of delivering a therapeutic agent into and across a microvascular blood-central nervous system (CNS) barrier in a subject, comprising: identifying a subject in need for treatment of a cancer in the brain; and administering to a subject with at least one of a CNS disease or disorder or a peripheral disease or disorder with CNS involvement, a composition comprising: a TCR mimic and active agent that together form a therapeutic agent; and a pharmaceutically acceptable carrier, wherein the therapeutic agent is encapsulated in a nanocontainer to which is linked the targeting molecule, wherein an effective barrier-entering and barrier crossing amount of the therapeutic agent enters and crosses the microvascular blood CNS barrier.
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FDA and the EMA, have initiated programs to directly monitor for safety issues rather than wait for patients, providers or manufacturers to report safety problems with products or medical devices.
The term “variant” when used in connection with antibodies refers to polypeptide sequence of an antibody that contains at least one amino acid substitution, deletion, or insertion in the variable region or the portion equivalent to the variable region, provided that the variant retains the desired binding affinity or biological activity.
In addition, an increase in parameters defined as “presence”, “degree”, “thickness”, and “re-epithelialization” of the epidermal layer was found, but the changes were less pronounced than those related to wound size.
The low number of registry PRCA cases hinders evaluation of potential associations with patient or treatment characteristics.
Biologicals are increasingly used to treat diseases such as multiple sclerosis, rheumatoid arthritis, cancer and anemia.
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ESA-induced PRCA, treatment includes cessation of ESA therapy and initiation of immunosuppressive therapy.
The book explains basic principles, then compares and contrasts approaches to both biopharmaceuticals (proteins) and small molecule drugs, presenting an overview of the business and management issues of these approaches.
Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.
The invention is also directed toward methods of using an excipient selected from the group consisting of creatinine, creatine or carnitine, or mixtures thereof, to stabilize or reduce viscosity of a pharmaceutical formulation of a therapeutic protein.
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Indeed, the estimates of cost savings are most sensitive to assumptions about the size of FoPP price discounts.
Now he has fallen, admitting that he blood doped, used steroids and erythropoietin (EPO), and exhibited disdain to those around him, both friend and foe.
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Luca De Nicola, Francesco Locatelli, Giuseppe Conte, Roberto Minutolo.
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Many production issues involving the fermentation process and possible contamination issues were successfully addressed by scientists and regulators working together in Lilly production facilities.
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Treating anaemia in a CKD cat is worthwhile.
Company, Limited (Kirin) for the development and commercialization of certain products based on advanced biotechnology.
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Otrovni proizvodi razmjene materija patogenih bakterija ili drugih oblika zivotinjskog ili biljnog zivota.
Protein solutions also have the potential for particulate formulation and aggregation, which may impact activity, effectiveness and possibly immunogenicity of the therapeutic protein.
Evaluation of arterial structure and function in pediatric patients with end-stage renal disease on dialysis and after renal transplantation.
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The table below and the following discussion of products in development may not be exhaustive.
The Company has accounted for operations in Venezuela as highly inflationary as the prior three-year cumulative inflation rate surpassed 100%.
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Examples of large-volume LMW products made by modern industrial microbial biosynthetic processes are (MSG), (riboflavin), and (ascorbic acid).
Knowledge and perception of off-label drug use amongst prescribing physicians in a tertiary care hospital.
Epoetin alfa and darbepoetin must be prescribed and dispensed in accordance with a risk evaluation and mitigation strategy (REMS) drafted by the manufacturer and approved by FDA.
It is also important to note that not all treatments work well for all women with endometriosis.
Auf Kuba wurde unter Federführung des staatlichen Centro de Ingeniería Genética y Biotecnología eine generische α-Variante in CHO-Zellen entwickelt, die vom Pharmaunternehmen Heber Biotec mit Sitz in Havanna unter dem Handelsnamen Heberitro für den heimischen Markt vertrieben wird.
Their portfolios comprise both custom manufacturing and API-for-generics.
Continued regulatory actions affecting the use of erythropoiesis-stimulating agents.
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Biosimilar epoetins and other biosimilar products have been recently approved in Europe and are discussed in detail below.
Growth hormone deficiency, GHD, is a pituitary disorder resulting in short stature and other physical ailments.
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Recombinant human erythropoietins (rhEPO) reliably increase hemoglobin levels in cancer patients experiencing chemotherapy-associated anemia.
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Quality of Life in CKD Patients Treated With Erythropoiesis-Stimulating Agents.
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As used herein, “HLA” is the human form of “MHC”.
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New data from a comparative study show that people experience significantly less pain and discomfort when given subcutaneous injections of the anaemia treatment NeoRecormon (epoetin beta) compared to Aranesp (darbepoetin alfa).
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Weighted treatment effects included typical risk ratio (RR), typical risk difference (RD), number needed to treat to benefit (NNTB), number needed to treat to harm (NNTH) and mean difference (MD), all with 95% confidence intervals (CI).
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The PRIMAVERA study protocol design: Evaluating the effect of continuous erythropoiesis receptor activator (C.
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These large data sets were then used to construct empirical phase diagrams (EPDs), radar charts, and comparative signature diagrams (CSDs) for data visualization and structural comparisons between the different proteins.
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While modeling FoPP heterogeneity directly is beyond the scope of this analysis, we can probe the effects of the likely outcome of such heterogeneity.
Fatigue in Patients Receiving Maintenance Dialysis: A Review of Definitions, Measures, and Contributing Factors.
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Biosimilars: Impact of Biologic Product Life Cycle and European Experience on the Regulatory Trajectory in the United States.
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As used herein, the terms “MHC light chain” and “MHC heavy chain” refer to portions of the MHC molecule.
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ELBW neonates are more likely to need transfusions even if their erythropoiesis is stimulated ().
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Measured values of non acid-treated controls (free sialic acids) were subtracted.
The intention-to-treat population therefore included 603 patients (301 patients in group 1 and 302 patients in group 2); of these, 476 (79%) completed the study.
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Anemia is a predictor of graft loss but not cardiovascular events and all-cause mortality in renal transplant recipients: follow-up data from the ALERT study.
FDA changed the term CRF to CKD in the ESA labels.
Use ferrous sulfate for iron replacement; if not well tolerated, try other iron salts (e.
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Exemplary therapeutic polypeptides suitable for use in the formulations and methods of the invention include human erythropoietin (SEQ ID NO: 1) or biologically active variants, derivatives, or analogs thereof, including chemically modified derivatives.
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Filed as exhibits to Form 10-K for the year ended December 31, 2000 on March 7, 2001 and incorporated herein by reference.
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In custom manufacturing, a specialty-chemicals company outsources the process development, pilot plant, and, finally, industrial-scale production of an active ingredient, or a predecessor thereof, to one, or a few, fine chemical companies.
Woodson B is a helpful article about blood transfusions.
In contrast, glycosylated biologics and biosimilars, which are considered comparable but distinct from a previously approved product with the same amino acid sequence, receive the root INN of the reference product plus a Greek letter suffix to indicate different glycosylation patterns.
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In addition, the hormones used during IVF do not cure the endometriosis lesions, which means that pain may recur after pregnancy and that not all women with endometriosis are able to become pregnant with IVF.
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