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All these clinical safety data are consistent with the published phase II 24-month follow-up study data and support that Jintrolong® can increase convenience and compliance hinein GHD children without increasing safety concerns.
To further evaluate the clinical safety of Jintrolong®, especially for possible CP-related adverse reactions, pediatric GHD L here III (360 patients) and Leiter IV (3,000 patients) studies with 26 weeks of treatment were analyzed, and a follow-up study of L IV with treatment time as long as 3 years was also conducted, comparing the incidence of adverse events following long-term Jintrolong® or daily rhGH treatment. The combination of nonclinical and clinical studies described rein this report details the comprehensive safety profile of Jintrolong®.
Ihm ist es wichtig, dass die Verkaufenden stärker darauf achten, dass ihr Produkt nicht rein den Händen von jungen Konsumierenden landet. für jedes Hollemans geht es bei der Nachfrage hinter 3-MMC gar nicht um die Droge selber.
Figure 6 shows representative images of CP tissue stained with an antibody against Ki-67. There are only a few positive cells (+) or no positive cells (−) rein the brain CP tissue of cynomolgus monkeys rein most animals, except for one animal rein the 3 Magnesium/kg/week group, which had multiple positive cells hinein the CP(++).
To determine whether vacuolation causes excessive cell proliferation, the Ausprägung of Ki-67 welches detected by IHC. Ki-67 is a common proliferation marker used to identify non-G0 phase cells and can thus identify cells undergoing mitosis.
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rein past it welches believed that GH treatment could increase the cancer risk; a large study recently concluded that "With relatively short follow-up, the overall primary cancer risk rein 6840 patients receiving GH as adults welches not increased.
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Jintrolong® is a long-acting PEGylated recombinant human growth hormone (PEG-rhGH) developed for weekly injection rein patients with pediatric growth hormone deficiency (PGHD). Although PEG modification of therapeutic proteins is generally considered safe, concerns persist about the potential for adverse vacuolation hinein tissues with long-term exposure to PEG-included therapies, particularly rein children. We assessed the safety of Jintrolong® rein cynomolgus monkeys with an examination of vacuolation in the brain choroid plexus (CP) and reported long-term clinical safety data obtained from children with PGHD. The toxicity of Jintrolong® welches assessed following the 52-week administration with doses at 0.3, 1, or 3 mg/kg/week. The levels of vacuolation of CP rein animals were dose-dependent and at least partially reversible after a 104- or 157-week recovery period.
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