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162 results

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Application of the model-informed drug development paradigm to datopotamab deruxtecan dose selection for late-stage development.
Lu Y, Liang S, Hong Y, Tajima N, Patel K, Li H, Wada DR, Greenberg J, Petrich A, Zebger-Gong H, Shuster D, Vaddady P. Lu Y, et al. Among authors: shuster d. CPT Pharmacometrics Syst Pharmacol. 2024 Jan;13(1):23-28. doi: 10.1002/psp4.13058. Epub 2023 Nov 1. CPT Pharmacometrics Syst Pharmacol. 2024. PMID: 37915242 Free PMC article. Clinical Trial.
Dosing Recommendation Based on the Effects of Different Meal Types on Pexidartinib Pharmacokinetics in Healthy Subjects: Implementation of Model-informed Drug Development Strategy.
Zahir H, Yin O, Hsu C, Wagner AJ, Jiang J, Wang X, Greenberg J, Shuster DE, Kakkar T, LaCreta F. Zahir H, et al. Among authors: shuster de. Clin Pharmacol Drug Dev. 2023 May;12(5):475-483. doi: 10.1002/cpdd.1240. Epub 2023 Mar 21. Clin Pharmacol Drug Dev. 2023. PMID: 36942508
Exposure-response analysis of efficacy and safety for pexidartinib in patients with tenosynovial giant cell tumor.
Yin O, Zahir H, French J, Polhamus D, Wang X, van de Sande M, Tap WD, Gelderblom H, Wagner AJ, Healey JH, Greenberg J, Shuster D, Stacchiotti S. Yin O, et al. Among authors: shuster d. CPT Pharmacometrics Syst Pharmacol. 2021 Nov;10(11):1422-1432. doi: 10.1002/psp4.12712. Epub 2021 Oct 14. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 34585528 Free PMC article.
Population Pharmacokinetic Analysis of Pexidartinib in Healthy Subjects and Patients With Tenosynovial Giant Cell Tumor or Other Solid Tumors.
Yin O, Wagner AJ, Kang J, Knebel W, Zahir H, van de Sande M, Tap WD, Gelderblom H, Healey JH, Shuster D, Stacchiotti S. Yin O, et al. Among authors: shuster d. J Clin Pharmacol. 2021 Apr;61(4):480-492. doi: 10.1002/jcph.1753. Epub 2020 Oct 11. J Clin Pharmacol. 2021. PMID: 33043474 Free PMC article. Clinical Trial.
Long-term outcomes of pexidartinib in tenosynovial giant cell tumors.
Gelderblom H, Wagner AJ, Tap WD, Palmerini E, Wainberg ZA, Desai J, Healey JH, van de Sande MAJ, Bernthal NM, Staals EL, Peterfy CG, Frezza AM, Hsu HH, Wang Q, Shuster DE, Stacchiotti S. Gelderblom H, et al. Among authors: shuster de. Cancer. 2021 Mar 15;127(6):884-893. doi: 10.1002/cncr.33312. Epub 2020 Nov 16. Cancer. 2021. PMID: 33197285 Free PMC article.
Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomised, placebo-controlled study.
Rimassa L, Assenat E, Peck-Radosavljevic M, Pracht M, Zagonel V, Mathurin P, Rota Caremoli E, Porta C, Daniele B, Bolondi L, Mazzaferro V, Harris W, Damjanov N, Pastorelli D, Reig M, Knox J, Negri F, Trojan J, López López C, Personeni N, Decaens T, Dupuy M, Sieghart W, Abbadessa G, Schwartz B, Lamar M, Goldberg T, Shuster D, Santoro A, Bruix J. Rimassa L, et al. Among authors: shuster d. Lancet Oncol. 2018 May;19(5):682-693. doi: 10.1016/S1470-2045(18)30146-3. Epub 2018 Apr 3. Lancet Oncol. 2018. PMID: 29625879 Clinical Trial.
Pexidartinib improves physical functioning and stiffness in patients with tenosynovial giant cell tumor: results from the ENLIVEN randomized clinical trial.
Van De Sande M, Tap WD, Gelhorn HL, Ye X, Speck RM, Palmerini E, Stacchiotti S, Desai J, Wagner AJ, Alcindor T, Ganjoo K, Martín-Broto J, Wang Q, Shuster D, Gelderblom H, Healey JH. Van De Sande M, et al. Among authors: shuster d. Acta Orthop. 2021 Aug;92(4):493-499. doi: 10.1080/17453674.2021.1922161. Epub 2021 May 12. Acta Orthop. 2021. PMID: 33977825 Free PMC article. Clinical Trial.
162 results