Peer Reviewed Journals

  1. Ooi QX, Kristofferson A, Korell J, Flack M, Plan E, Weber B. Bounded integer model-based meta-analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357. CPT Pharmacometrics Syst Pharmacol. 2023. 
  2. Schmid U, Weber B, Sarr C, Freiwald M. Exposure-safety analyses of nintedanib in patients with chronic fibrosing interstitial lung disease. BMC Pulmonary Medicine. 2021: 21. 
  3. Galluppi GR, Brar S, Caro L, Chen Y, Frey N, Grimm HP, Rudd DJ, Li CC, Magee M, Mukherjee A, Nagat L, Purohit VS, Roy A, Salem AH, Sinha V, Suleiman AA, Taskar KS, Upreti VV, Weber B, Cook J. Industrial Perspective on the Benefits Realized from the FDA's Model-Informed Drug Development Paired Meeting Pilot Program. Clin Pharmacol Ther. 110; 1172-5.
  4. Schmid U, Weber B, Magnusson MO, Freiwald M. Exposure-efficacy analyses of Nintedanib in patients with chronic fibrosis interstitial lung disease. Respiratory Medicine. 2020; 180.
  5. Tang F, Weber B, Stowasser S, Korell J. Parametric Time-to-Event Model for Acute Exacerbations in Idiopathic Pulmonary Fibrosis. CPT Pharmacometrics Syst Pharmacol. 2020; 9:87-95.
  6. Geng J, Lu S, Kurup S, Weber B, Ting N. Pharmacokinetics-Guided Dose Allocation in Comparison with Binary Dose Spacing. Stat Biosci. 2019; 11: 677-93.
  7. Sharma A, Weber B, Meibohm B. Long Pulmonary Residence Time and Plasma Half-Life of Tiotropium: Implications for Pharmacokinetic Bioequivalence Studies. Clin Drug Investig. 2017; 37: 705. 

  8. Sharma A, Kerstjens HA, Aalbers R, Moroni-Zentgraf P, Weber B, Dahl R. Pharmacokinetics of tiotropium administered by Respimat(R) in asthma patients: Analysis of pooled data from phase II and III clinical trials. Pulm Pharmacol Ther. 2016;42: 25-32

  9. Nguyen TH, Mouksassi MS, Holford N, Al-Huniti N, Freedman I, Hooker AC, John J, Karlsson MO, Mould DR, Perez Ruixo JJ, Plan EL, Savic R, van Hasselt JG, Weber B, Zhou C, Comets E, Mentre F. Model evaluation of continuous data pharmacometric models: Metrics and graphics. CPT Pharmacometrics Syst Pharmacol. 2016;6: 87-109

  10. Weber B, Borghardt JM, Parra-Guillen ZP, Sharma A, Retlich S, Staab A, Troconiz IF. Tiotropium Pharmacokinetics and Pharmacodynamics - What are Drivers for Systemic Levels and Local Pulmonary Responses? Respiratory Drug Delivery 2016. 2016;1:45-54.

  11. Borghardt JM, Weber B, Staab A, Kunz C, Kloft C. Model-based evaluation of pulmonary pharmacokinetics in asthmatic and COPD patients after oral olodaterol inhalation. Br J Clin Pharmacol. 2016;82:739-53.

  12. Borghardt JM, Weber B, Staab A, Kunz C, Formella S, Kloft C. Investigating pulmonary and systemic pharmacokinetics of inhaled olodaterol in healthy volunteers using a population pharmacokinetic approach. Br J Clin Pharmacol. 2016;81:538-52.

  13. Sharma A, Weber B, Wein M, Hallmann C, Meibohm B. Essential criteria for pharmacokinetic studies supporting bioequivalence of inhaled tiotropium bromide products. Clin Pharmacol Drug Dev. 2016;5:52-6.

  14. Weber B, Hochhaus G. A Systematic Analysis of the Sensitivity of Plasma Pharmacokinetics to Detect Differences in the Pulmonary Performance of Inhaled Fluticasone Propionate Products Using a Model-Based Simulation Approach. AAPS J. 2015;17:999-1010.

  15. Weber B, Lee SL, Delvadia R, Lionberger R, Li BV, Tsong Y, Hochhaus G. Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing. AAPS J. 2015;17:370-9.

  16. Borghardt JM, Weber B, Staab A, Kloft C. Pharmacometric Models for Characterizing the Pharmacokinetics of Orally Inhaled Drugs. AAPS J. 2015;17:853-70.

  17. Borghardt JM, Weber B, Staab A, Kloft C. Impact of Pulmonary Dissolution and Pulmonary Absorption Processes on the Pulmonary and Systemic Pharmacokinetics of Inhaled Drugs: An In Silico Analysis. RDD Europe 2015. 2015;2:299-304.

  18. Weber B, Troconiz IF, Borghardt JM, Staab A, Sharma A. Model-Based Evaluation of Single and Multiple Dose Pharmacokinetics of Inhaled Tiotropium in Healthy Volunteers and Implications for Systemic Exposure Studies. RDD Europe 2015. 2015;2:249-54.

  19. Leiner S, Weber B. Is the EMA Guideline on Therapeutic Equivalence of Inhalation Products Up to Date? RDD Europe 2015. 2015;2:245-8.

  20. Hurtado FK, Weber B, Derendorf H, Hochhaus G, Dalla Costa T. Population pharmacokinetic modeling of the unbound levofloxacin concentrations in rat plasma and prostate tissue measured by microdialysis. Antimicrob Agents Chemother. 2014;58:678-86.

  21. Borghardt JM, Weber B, Staab A, Kunz C, Schiewe J, Kloft C. Expanding the Mechanistic Knowledge About Pulmonary Absorption Processes Using a Population Pharmacokinetic Model for Inhaled Olodaterol. Respiratory Drug Delivery 2014. 2014;2:417-22.

  22. Weber B, Lee SL, Lionberger R, Li BV, Tsong Y, Hochhaus G. A sensitivity analysis of the modified chi-square ratio statistic for equivalence testing of aerodynamic particle size distribution. AAPS J. 2013;15:465-76.

  23. Weber B, Hochhaus G, Adams W, Lionberger R, Li B, Tsong Y, Lee SL. A Stability Analysis of a Modified Version of the Chi-Square Ratio Statistic: Implications for Equivalence Testing of Aerodynamic Particle Size Distribution. AAPS J. 2013;15:1-9.

  24. Weber B, Hochhaus G. A pharmacokinetic simulation tool for inhaled corticosteroids. AAPS J. 2013;15:159-71.

  25. Scherliess R, Buske S, Young K, Weber B, Rades T, Hook S. In vivo evaluation of chitosan as an adjuvant in subcutaneous vaccine formulations. Vaccine. 2013;31:4812-9.

  26. Weber B, Adams W, Lionberger R, Li B, Tsong Y, Hochhaus G, Lee SL. Evaluation of Statistical Methods for Determining Equivalence of Aerodynamic Particle Size Distribution. Respiratory Drug Delivery 2012. 2012;3:803-8.

  27. Haug KG, Weber B, Hochhaus G, Butterweck V. Nonlinear pharmacokinetics of visnagin in rats after intravenous bolus administration. Eur J Pharm Sci. 2012;45:79-89.

  28. Haug KG, Weber B, Hochhaus G, Butterweck V. Pharmacokinetic evaluation of visnagin and Ammi visnaga aqueous extract after oral administration in rats. Planta Med. 2012;78:1831-6.

  29. Wu K, Blomgren AL, Ekholm K, Weber B, Edsbaecker S, Hochhaus G. Budesonide and ciclesonide: effect of tissue binding on pulmonary receptor binding. Drug Metab Dispos. 2009;37:1421-6.

     

Conference Contributions

  1. Ooi QX, Kristoffersson A, Korell J, Flack M, Plan EL, Weber B. Bounded integer model-based analysis of psoriasis area and severity index in patients with moderate-to-severe plaque psoriasis receiving BI 730357 treatment. PAGE 2022. Ljubljana, Slovenia. 
  2. Minichmayr IK, Plan EL, Weber B, Ueckert S. Beyond disease progression - Item response theory modeling to gain structural insights into disease facts underlying clinical score assessments. PAGE 2021.
  3. Minichmayr IK, Plan EL, Weber B, Ueckert S. Unveiling determinants of nonalcoholic fatty liver disease (NAFLD) activity and nonalcoholic steatohepatitis (NASH) using item response modeling. 2020 ACoP11. 
  4. Vaidya T, Weber B, Stowasser S, Korell J. Model-based population analysis of disease progression in idiopathic pulmonary fibrosis. 2020 ASCPT Annual Meeting; Houston, TX. 
  5. Kluwe F, Maas M, Hennige A, Weber B, Kloft C. How predictive is short-term body weight loss in the longer term for decision-making during clinical drug development? 2019 ACoP10; Orlando, FL. 
  6. Tang F, Weber B, Stowasser S, Korell J. Time-to-event model for acute exacerbations in idiopathic pulmonary fibrosis (IPF). 2019 ASCPT Annual Meeting; Washington, DC.
  7. Friedrich C, Weber B, Pryor M, Witt C, Borghardt J, Disse B, Dallinger C, Gupta A, Jung B, Fowler A, Singh D. Development of the Respiratory PhysioPD (R) Platform, a QSP Model to Investigate Biological Mechanisms Underlying Bronchoconstriction. 2018 ACoP9; San Diego, CA.
  8. Schmid U, Weber B, Dallinger C, Richeldi L, Hallmann C, Raghu G, Freiwald M. Relationship between nintedanib exposure, clinical efficacy and adverse events in patients with idiopathic pulmonary fibrosis (IPF).  2016 ACoP7; Bellevue, WA. 
  9. Schmid U, Weber B, Dallinger C, Richeldi L, Hallmann C, Raghu G, Freiwald M. Relationship between nintedanib exposure, patient characteristics and clinical efficacy in patients with idiopathic pulmonary fibrosis.  2016 ATS Congress; San Francisco, CA. 
  10. Schmid U, Weber B, Dallinger C, Luca Richeldi, Hallmann C, Raghu G, Freiwald M. Relationship between nintedanib exposure and adverse events in patients with idiopathic pulmonary fibrosis.  ERS Internation Congress 2016; London, United Kingdom. 
  11. Bateman E, Mackie A, Benediktus E, Schepers C, Kim JM, Tadayasu Y, Lee G, Wood C, Weber B. Safety, pharmacokinetics and pharmacodynamics of BI 1060469, a novel oral CRTH2 antagonist.  ERS International Congress 2016; London, UK. 
  12. Weber B, Borghardt JM. New Insights in the Pulmonary Fate of Inhaled Drugs.  2015 PAGE Meeting; Hersonissos, Greece. 
  13. Sharma A, Weber B, Stopfer P, Borghardt JM, Rapp B, Schmid M, Hallmann C, Moroni-Zentgraf P. Tiotropium Pharmacokinetics in Patients with Asthma - A Pooled Analysis.  2015 ACCP Meeting; San Francisco, CA. 
  14. Schilling U, Miesler T, Weber B, Hochhaus G. A Semi-Mechanistic Model for Predicting the Nasal and Plasma Pharmacokinetics of Intranasal Corticosteroids.  2015 ACCP Meeting; San Francisco, CA. 
  15. Miesler T, Schilling U, Weber B, Hochhaus G. An open-source, user-friendly simulation tool to predict the pharmacokinetics of inhaled corticosteroids.  2015 ACCP Meeting; San Francisco, CA. 
  16. Borghardt JM, Weber B, Staab A, Kunz C, Schiewe J, Kloft C. The physiological interpretation of population pharmacokinetic modelling results for inhaled olodaterol.  2015 PAGE Meeting; Hersonissos, Greece. 
  17. Borghardt JM, Weber B, Staab A, Kloft C. A New Parameterisation to Describe Parallel Absorption Processes After Drug Inhalation.  2015 PAGE Meeting; Hersonissos, Greece. 
  18. Parra-Guillen Z, Weber B, Sharma A, Freijer J, Retlich S, Borghardt J, Troconiz I. Population Pharmacokinetic Analysis of Tiotropium in Healthy Volunteers after Intravenous Administration and Inhalation.  2014 ACoP Las Vegas, NV. 
  19. Borghardt J, Weber B, Staab A, Kunz C, Schiewe J, Kloft C. The physiological interpretation of population pharmacokinetic modelling results for inhaled olodaterol.  PAGE 2014; Alicante, Spain. 
  20. Zhao L, Weber B, Hochhaus G. A Simulation Tool for Evaluating EMAs Regulatory PK Limits for Bioequivalence Testing of Inhaled Corticosteroids.  2013 ACCP Meeting; Bethesda, MD. 
  21. Kandala B, Weber B, Winner L, Hochhaus G. Evaluation of the Feasibility of Pharmacodynamic Bioequivalence Studies of Inhaled Corticosteroids through Monte Carlo Simulations.  ISAM 2013; Chapel Hill, NC. 
  22. Kandala B, Weber B, Winner L, Hochhaus G. Power Calculations for Pharmacodynamic Crossover Studies Conducted to establish Bioequivalence of Inhaled Corticosteroids Through Monte Carlo Simulations.  2013 ACoP; Ft. Lauderdale, FL. 
  23. Kandala B, Weber B, Joseph R, Maas B, Hochhaus G. A New Simulation Model to Assess the Power of Pharmacodynamic Crossover Studies Conducted to Establish Bioequivalence of Orally Inhaled Drug Products.  2013 ACCP Meeting; Bethesda, MD. 
  24. Hurtado F, Zimmermann E, Weber B, Derendorf H, Dalla Costa T. Free Levooxacin Concentrations in Prostate and Lung Modeled by a Population Pharmacokinetic Approach.  7th International Symposium on Microdialysis; Poitiers, France. 
  25. Weber B, Hochhaus G. A Clinical Trial Simulation Tool for the Suppression of the Endogenous Cortisol Release after Administration of Inhaled Corticosteroids.  2012 GPEN Meeting Melbourne, Australia. 
  26. Hurtado F, Weber B, Derendorf H, Dalla Costa T. Population Pharmacokinetic Modeling of the Unbound Levooxacin Concentrations in Plasma and Prostate Tissue Measured by Microdialysis in Rats.  4th Meeting of the Pharmaceutical Sciences Graduate Program; Porto Alegre, Brazil. 
  27. Haug KG, Weber B, Derendorf H, Butterweck V. Characterization of the pharmacokinetic properties of visnagin and Ammi visnaga water extract following oral administration in rats.  DPhG Jahrestagung 2012; Greifswald, Germany. 
  28. Weber B, Adams W, Lionberger R, Li B, Tsong Y, Hochhaus G, Lee S. Evaluation of Statistical Methods for Determining Equivalence of Aerodynamic Particle Size Distribution.  2011 AAPS Annual Meeting; Washington, DC. 
  29. Weber B, Goyal N, Kandala B, Hochhaus G. Simulation-based evaluation of tmax as a pharmacokinetic parameter to assess bioequivalence of inhaled corticosteroids.  2010 ACCP Meeting; Baltimore, MD. 
  30. Weber B, Goyal N, Hochhaus G. Simulation-based evaluation of tmax as a pharmacokinetic parameter to assess bioequivalence of inhaled corticosteroids.  23rd Annual Research Showcase and Awards Recognition Day at University of Florida; Gainesville, FL. 
  31. Kandala B, Weber B, Hochhaus G. Clinical Trial Simulations Using an Improved Inhalation Model to Evaluate the Potential of Pharmacokinetic Studies in Establishing Bioequivalence of Inhaled Corticosteroids.  2010 APPS Annual Meeting; New Orleans, LA. 
  32. Weber B, Wu K, Blomgren A, Ekholm K, Edsbaecker S, Hochhaus G. Effect of protein binding on pulmonary corticosteroid receptor occupancy.  7th Retrometabolism Based Drug Design and Targeting Conference; Orlando, FL. 
  33. Goyal N, Weber B, Hochhaus G. Bioequivalence of Inhaled Corticosteroids - A Pharmacokinetic Approach.  7th Retrometabolism Based Drug Design and Targeting Conference; Orlando, FL.

Contact 

E-Mail: benjamin.weber.pmx@gmail.com