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Physiologically Based Pharmacokinetic Model Qualification and Reporting Procedures for Regulatory Submissions: A Consortium Perspective.
Shebley M, Sandhu P, Emami Riedmaier A, Jamei M, Narayanan R, Patel A, Peters SA, Reddy VP, Zheng M, de Zwart L, Beneton M, Bouzom F, Chen J, Chen Y, Cleary Y, Collins C, Dickinson GL, Djebli N, Einolf HJ, Gardner I, Huth F, Kazmi F, Khalil F, Lin J, Odinecs A, Patel C, Rong H, Schuck E, Sharma P, Wu SP, Xu Y, Yamazaki S, Yoshida K, Rowland M. Shebley M, et al. Among authors: djebli n. Clin Pharmacol Ther. 2018 Jul;104(1):88-110. doi: 10.1002/cpt.1013. Epub 2018 Feb 2. Clin Pharmacol Ther. 2018. PMID: 29315504 Free PMC article. Review.
Population Pharmacokinetic/Pharmacodynamic Analysis of Alirocumab in Healthy Volunteers or Hypercholesterolemic Subjects Using an Indirect Response Model to Predict Low-Density Lipoprotein Cholesterol Lowering: Support for a Biologics License Application Submission: Part II.
Nicolas X, Djebli N, Rauch C, Brunet A, Hurbin F, Martinez JM, Fabre D. Nicolas X, et al. Among authors: djebli n. Clin Pharmacokinet. 2019 Jan;58(1):115-130. doi: 10.1007/s40262-018-0670-5. Clin Pharmacokinet. 2019. PMID: 29725997 Free PMC article. Clinical Trial.
Characterization of the pharmacokinetics of entrectinib and its active M5 metabolite in healthy volunteers and patients with solid tumors.
Meneses-Lorente G, Bentley D, Guerini E, Kowalski K, Chow-Maneval E, Yu L, Brink A, Djebli N, Mercier F, Buchheit V, Phipps A. Meneses-Lorente G, et al. Among authors: djebli n. Invest New Drugs. 2021 Jun;39(3):803-811. doi: 10.1007/s10637-020-01047-5. Epub 2021 Jan 18. Invest New Drugs. 2021. PMID: 33462752 Free PMC article. Clinical Trial.
In vitro and clinical investigations to determine the drug-drug interaction potential of entrectinib, a small molecule inhibitor of neurotrophic tyrosine receptor kinase (NTRK).
Meneses-Lorente G, Fowler S, Guerini E, Kowalski K, Chow-Maneval E, Yu L, Mercier F, Ullah M, Umehara K, Brink A, Buchheit V, Zwanziger E, Phipps A, Djebli N. Meneses-Lorente G, et al. Among authors: djebli n. Invest New Drugs. 2022 Feb;40(1):68-80. doi: 10.1007/s10637-021-01156-9. Epub 2021 Aug 21. Invest New Drugs. 2022. PMID: 34417912 Free PMC article.
Population pharmacokinetic analysis of entrectinib in pediatric and adult patients with advanced/metastatic solid tumors: support of new drug application submission.
González-Sales M, Djebli N, Meneses-Lorente G, Buchheit V, Bonnefois G, Tremblay PO, Frey N, Mercier F. González-Sales M, et al. Among authors: djebli n. Cancer Chemother Pharmacol. 2021 Dec;88(6):997-1007. doi: 10.1007/s00280-021-04353-8. Epub 2021 Sep 18. Cancer Chemother Pharmacol. 2021. PMID: 34536094 Clinical Trial.
35 results