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  1. Article

    Open Access

    Accelerated first-in-human clinical trial of EIDD-2801/MK-4482 (molnupiravir), a ribonucleoside analog with potent antiviral activity against SARS-CoV-2

    A recently published article described the safety, tolerability, and pharmacokinetic profile of molnupiravir (Painter et al. 2021), a novel antiviral agent with potent activity against severe acute respiratory...

    Wendy Holman, Wayne Holman, Stacy McIntosh, Wendy Painter, George Painter in Trials (2021)

  2. Article

    Open Access

    A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects

    FKB327 is a biosimilar of the adalimumab reference product (RP). The primary objective was to assess the relative bioavailability of FKB327 after a single subcutaneous (SC) dose via prefilled syringe (PFS), au...

    Jim Bush, Kazuki Kawakami, Rafael Muniz in BMC Pharmacology and Toxicology (2019)

  3. Article

    Open Access

    Characterization of the Pharmacokinetics of Vilaprisan: Bioavailability, Excretion, Biotransformation, and Drug–Drug Interaction Potential

    In-vitro data suggest that clearance of vilaprisan is mediated by cytochrome P450 3A4 (oxidation) and aldoketoreductases (reduction). To fully understand the elimination and biotransformation pathways of vilap...

    Marcus-Hillert Schultze-Mosgau, Joachim Höchel, Olaf Prien in Clinical Pharmacokinetics (2018)