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Patients with growth hormone deficiency associated with intracranial lesions should undergo regular examinations for progression or relapse of the disease.
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Cynomolgus monkeys received subcutaneous injections of 1 Magnesium/kg/week Jintrolong® or excipient control once weekly for 26 consecutive weeks, followed by a 26-week recovery period to investigate the possible vacuolation of the CP and the potential for reversibility following recovery rein non-human primates treated with Jintrolong®.
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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 Leiter cells and can thus identify cells undergoing mitosis.
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Animals in the 0.3 mg/kg/week Jintrolong® group developed vacuoles to a similar extent compared to animals hinein the excipient control group. Thus, under the conditions of this study, the NOEL was determined to be 0.3 mg/kg/week. The NOAEL welches determined to Beryllium 3 mg/kg/week as the vacuolation hinein CP cells did not elicit structural changes and is not expected to have resulted rein functional impairment hinein cynomolgus monkeys.
A functional observational battery (FOB) of neurobehavioral assessments welches conducted to detect any neurobehavioral deficits resulting from potential CP dysfunction, including home cage observations, out-of-cage observations, and open field activity assessments rein animals of both control and animals treated with 0.
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Notizblock randomization method was performed using SAS version 9.4 (SAS Institute, Cary, NC, USA). All subjects eligible for the study were given a random number in the order of enrollment, and a central randomization Struktur welches used to determine whether the subject was allocated to the treatment or control group. The random unique identifier generated for each subject welches used throughout the study.
kilometer is the Michaelis constant, and Vmax is the maximum Tarif of elimination of the nonlinear pathway. Vc is the volume of distribution of the central compartment. F stands for bioavailability.
Notably, the vacuolation of epithelial cells of brain CP welches found to be reversible or partially reversible hinein a dose-dependent manner rein our nonclinical study. This result is consistent with the review by Ivens et al. and further supports that the formation of cellular vacuoles is reversible given sufficient recovery time after the vacuolation-inducing agent welches removed (15, 43). The main contributor that determines the rate of PEG accumulation hinein cells and subsequently induces vacuolation is the slow metabolism of PEG and the turnover Satz of the cells. The ether linkages between ethylene glycol subunits in PEG molecular are biologically stable because of the lack of mammalian etherases (44). Jintrolong® contains methoxy-capped PEG, which renders the oxidation of Am ende gelegen hydroxyl to carboxyl groups of PEGs caused by alcohol dehydrogenase negligible (45). PEG chain degradation has been observed to Beryllium slow (46, 47), and degraded PEG is eliminated slowly through the kidney or excreted through the bile to avoid high molecular weight PEG accumulation when PEG is administered hinein small amounts (48). There are also publications proposing the hypothesis of “reputation,” which claims that rod-shaped and stiff molecules can pass through renal glomeruli even at higher molecular sizes (45).
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