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  1. Article

    Open Access

    Quality Assurance of PBPK Modeling Platforms and Guidance on Building, Evaluating, Verifying and Applying PBPK Models Prudently under the Umbrella of Qualification: Why, When, What, How and By Whom?

    Modeling and simulation emerges as a fundamental asset of drug development. Mechanistic modeling builds upon its strength to integrate various data to represent a detailed structural knowledge of a physiologic...

    Sebastian Frechen, Amin Rostami-Hodjegan in Pharmaceutical Research (2022)

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  2. No Access

    Article

    A Physiologically Based Pharmacokinetic Model of Voriconazole Integrating Time-Dependent Inhibition of CYP3A4, Genetic Polymorphisms of CYP2C19 and Predictions of Drug–Drug Interactions

    Voriconazole, a first-line antifungal drug, exhibits nonlinear pharmacokinetics (PK), together with large interindividual variability but a narrow therapeutic range, and markedly inhibits cytochrome P450 (CYP)...

    **a Li, Sebastian Frechen, Daniel Moj, Thorsten Lehr… in Clinical Pharmacokinetics (2020)

  3. Article

    Open Access

    Physiologically Based Pharmacokinetic Models for Prediction of Complex CYP2C8 and OATP1B1 (SLCO1B1) Drug–Drug–Gene Interactions: A Modeling Network of Gemfibrozil, Repaglinide, Pioglitazone, Rifampicin, Clarithromycin and Itraconazole

    Drug–drug interactions (DDIs) and drug–gene interactions (DGIs) pose a serious health risk that can be avoided by dose adaptation. These interactions are investigated in strictly controlled setups, quantifying...

    Denise Türk, Nina Hanke, Sarah Wolf, Sebastian Frechen… in Clinical Pharmacokinetics (2019)

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  4. No Access

    Article

    Clarithromycin, Midazolam, and Digoxin: Application of PBPK Modeling to Gain New Insights into Drug–Drug Interactions and Co-medication Regimens

    Clarithromycin is a substrate and mechanism-based inhibitor of cytochrome P450 (CYP) 3A4 as well as a substrate and competitive inhibitor of P-glycoprotein (P-gp) and organic anion-transporting polypeptides (O...

    Daniel Moj, Nina Hanke, Hannah Britz, Sebastian Frechen… in The AAPS Journal (2017)

  5. Article

    A Modeling and Simulation Framework for Adverse Events in Erlotinib-Treated Non-Small-Cell Lung Cancer Patients

    Treatment with erlotinib, an epidermal growth factor receptor tyrosine kinase inhibitor used for treating non-small-cell lung cancer (NSCLC) and other cancers, is frequently associated with adverse events (AE)...

    Ahmed Abbas Suleiman, Sebastian Frechen, Matthias Scheffler… in The AAPS Journal (2015)

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  6. No Access

    Article

    Author’s Reply to Kotlinska-Lemieszek: “Should Midazolam Drug–Drug Interactions Be of Concern to Palliative Care Physicians?”

    Sebastian Frechen, Jan Gaertner in Drug Safety (2013)

  7. No Access

    Article

    A Semiphysiological Population Pharmacokinetic Model for Dynamic Inhibition of Liver and Gut Wall Cytochrome P450 3A by Voriconazole

    Accurate predictions of cytochrome P450 (CYP) 3A-mediated drug-drug interactions (DDIs) account for dynamic changes of CYP3A activity at both major expression sites (liver and gut wall) by considering the full...

    Sebastian Frechen, Lisa Junge, Teijo I. Saari… in Clinical Pharmacokinetics (2013)

  8. No Access

    Article

    Recommending early integration of palliative care — does it work?

    In 2006, our comprehensive cancer center decided to implement early integration (EI) of palliative care (PC) by (a) literally adopting the WHO definition of PC into cancer care guidelines and (b) providing a PC c...

    Jan Gaertner, Juergen Wolf, Sebastian Frechen, Ursula Klein… in Supportive Care in Cancer (2012)