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Model-Informed Drug Development: Steps Toward Harmonized Guidance.
Marshall S, Ahamadi M, Chien J, Iwata D, Farkas P, Filipe A, Frey N, Greene E, Kawai N, Li J, Lippert J, Musuamba Tshinanu F, Manolis E, Peterson MC, Sarem S, Shebley M, Tegenge M, Tsai CH, Tu CL, Otsubo Y, Wei J, Zhang L, Zhu H, Karlsson KE. Marshall S, et al. Among authors: lippert j. Clin Pharmacol Ther. 2023 Nov;114(5):954-959. doi: 10.1002/cpt.3006. Epub 2023 Aug 3. Clin Pharmacol Ther. 2023. PMID: 37534711 No abstract available.
Good Practices in Model-Informed Drug Discovery and Development: Practice, Application, and Documentation.
EFPIA MID3 Workgroup; Marshall SF, Burghaus R, Cosson V, Cheung SY, Chenel M, DellaPasqua O, Frey N, Hamrén B, Harnisch L, Ivanow F, Kerbusch T, Lippert J, Milligan PA, Rohou S, Staab A, Steimer JL, Tornøe C, Visser SA. EFPIA MID3 Workgroup, et al. Among authors: lippert j. CPT Pharmacometrics Syst Pharmacol. 2016 Mar;5(3):93-122. doi: 10.1002/psp4.12049. Epub 2016 Mar 14. CPT Pharmacometrics Syst Pharmacol. 2016. PMID: 27069774 Free PMC article.
NT-proBNP Qualifies as a Surrogate for Clinical End Points in Heart Failure.
Schmitt W, Rühs H, Burghaus R, Diedrich C, Duwal S, Eissing T, Garmann D, Meyer M, Ploeger B, Lippert J. Schmitt W, et al. Among authors: lippert j. Clin Pharmacol Ther. 2021 Aug;110(2):498-507. doi: 10.1002/cpt.2222. Epub 2021 Mar 27. Clin Pharmacol Ther. 2021. PMID: 33630302 Free PMC article.
Quantitative Systems Pharmacology Approaches for Immuno-Oncology: Adding Virtual Patients to the Development Paradigm.
Chelliah V, Lazarou G, Bhatnagar S, Gibbs JP, Nijsen M, Ray A, Stoll B, Thompson RA, Gulati A, Soukharev S, Yamada A, Weddell J, Sayama H, Oishi M, Wittemer-Rump S, Patel C, Niederalt C, Burghaus R, Scheerans C, Lippert J, Kabilan S, Kareva I, Belousova N, Rolfe A, Zutshi A, Chenel M, Venezia F, Fouliard S, Oberwittler H, Scholer-Dahirel A, Lelievre H, Bottino D, Collins SC, Nguyen HQ, Wang H, Yoneyama T, Zhu AZX, van der Graaf PH, Kierzek AM. Chelliah V, et al. Among authors: lippert j. Clin Pharmacol Ther. 2021 Mar;109(3):605-618. doi: 10.1002/cpt.1987. Epub 2020 Aug 14. Clin Pharmacol Ther. 2021. PMID: 32686076 Free PMC article. Review.
Predictive Performance of Physiology-Based Pharmacokinetic Dose Estimates for Pediatric Trials: Evaluation With 10 Bayer Small-Molecule Compounds in Children.
Ince I, Dallmann A, Frechen S, Coboeken K, Niederalt C, Wendl T, Block M, Meyer M, Eissing T, Burghaus R, Lippert J, Willmann S, Schlender JF. Ince I, et al. Among authors: lippert j. J Clin Pharmacol. 2021 Jun;61 Suppl 1(Suppl 1):S70-S82. doi: 10.1002/jcph.1869. J Clin Pharmacol. 2021. PMID: 34185905 Free PMC article.
Predictive Pediatric Modeling and Simulation Using Ontogeny Information.
Ince I, Solodenko J, Frechen S, Dallmann A, Niederalt C, Schlender J, Burghaus R, Lippert J, Willmann S. Ince I, et al. Among authors: lippert j. J Clin Pharmacol. 2019 Sep;59 Suppl 1:S95-S103. doi: 10.1002/jcph.1497. J Clin Pharmacol. 2019. PMID: 31502689 Review.
Application of Physiologically-Based and Population Pharmacokinetic Modeling for Dose Finding and Confirmation During the Pediatric Development of Moxifloxacin.
Willmann S, Frei M, Sutter G, Coboeken K, Wendl T, Eissing T, Lippert J, Stass H. Willmann S, et al. Among authors: lippert j. CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):654-663. doi: 10.1002/psp4.12446. Epub 2019 Aug 7. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31310051 Free PMC article.
A generic framework for the physiologically-based pharmacokinetic platform qualification of PK-Sim and its application to predicting cytochrome P450 3A4-mediated drug-drug interactions.
Frechen S, Solodenko J, Wendl T, Dallmann A, Ince I, Lehr T, Lippert J, Burghaus R. Frechen S, et al. Among authors: lippert j. CPT Pharmacometrics Syst Pharmacol. 2021 Jun;10(6):633-644. doi: 10.1002/psp4.12636. Epub 2021 May 24. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 33946131 Free PMC article.
195 results