Publications by authors named "K Shakeri-Nejad"

Article Synopsis
  • Omalizumab, an anti-IgE monoclonal antibody, is used to treat conditions like asthma and chronic urticaria and is available in new injection formats for better patient convenience.
  • A study aimed to determine if new injection configurations (PFS-AI and PFS-NSD) were pharmacokinetically bioequivalent to the current configuration, using measurements like concentration (C) and area under the curve (AUC).
  • Results showed that both new configurations met the bioequivalence criteria with confidence intervals within the acceptable range, and safety profiles were consistent with existing data on omalizumab.
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Triclabendazole is an effective and well-tolerated treatment for human fascioliasis. A placebo- and positive-controlled, four-sequence by four-period crossover study was conducted in 45 healthy participants to assess the effect of therapeutic (10 mg/kg twice daily [b.i.

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Article Synopsis
  • - Maladjusted immune responses in COVID-19 can lead to severe issues like cytokine release syndrome and respiratory distress, signaling the need for effective treatments.
  • - Sphingosine-1-phosphate (S1P) and its receptors play a vital role in keeping blood vessel integrity and regulating immune cell movements, potentially improving outcomes in severe COVID-19 cases.
  • - The use of S1PR modulators like fingolimod and siponimod shows promise in reducing inflammation and could be beneficial for critically ill COVID-19 patients experiencing hyperinflammation.
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Abuse and misuse of prescription drugs remains an ongoing concern in the USA and worldwide; thus, all centrally active new drugs must be assessed for abuse and dependence potential. Sphingosine-1-phosphate (S1P) receptor modulators are used primarily in the treatment of multiple sclerosis. Among the new S1P receptor modulators, siponimod, ozanimod, and ponesimod have recently been approved in the USA, European Union (EU), and other countries.

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Purpose: The goal of this study was to assess the safety, tolerability, pharmacodynamics (PD) and pharmacokinetics (PK) of intravenous (IV) siponimod in healthy subjects.

Methods: This randomized, open-label study was conducted in 2 parts. In Part 1, a total of 16 eligible subjects received either a single oral dose of siponimod (0.

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