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  1. No Access

    Article

    Systemic Bioequivalence Is Unlikely to Equal Target Site Bioequivalence for Nanotechnology Oncologic Products

    Approval of generic drugs by the US Food and Drug Administration (FDA) requires the product to be pharmaceutically equivalent to the reference listed drug (RLD) and demonstrate bioequivalence (BE) in effective...

    Jessie L.-S. Au, Ze Lu, Roberto A. Abbiati, M. Guillaume Wientjes in The AAPS Journal (2019)

  2. No Access

    Article

    Is It Time to Use Modeling of Cellular Transporter Homeostasis to Inform Drug-Drug Interaction Studies: Theoretical Considerations

    Mathematical modeling has been an important tool in pharmaceutical research for 50 + years and there is increased emphasis over the last decade on using modeling to improve the efficiency and effectiveness of ...

    Roberto A. Abbiati, M. Guillaume Wientjes, Jessie L.-S. Au in The AAPS Journal (2021)

  3. Article

    Open Access

    Quantitative Systems Pharmacology Modeling of Avadomide-Induced Neutropenia Enables Virtual Clinical Dose and Schedule Finding Studies

    Avadomide is a cereblon E3 ligase modulator and a potent antitumor and immunomodulatory agent. Avadomide trials are challenged by neutropenia as a major adverse event and a dose-limiting toxicity. Intermittent...

    Roberto A. Abbiati, Michael Pourdehnad, Soraya Carrancio… in The AAPS Journal (2021)

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  4. Article

    Correction to: Quantitative Systems Pharmacology Modeling of Avadomide-Induced Neutropenia Enables Virtual Clinical Dose and Schedule Finding Studies

    Roberto A. Abbiati, Michael Pourdehnad, Soraya Carrancio… in The AAPS Journal (2022)

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