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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: sharma p. 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.
Advancing Predictions of Tissue and Intracellular Drug Concentrations Using In Vitro, Imaging and Physiologically Based Pharmacokinetic Modeling Approaches.
Guo Y, Chu X, Parrott NJ, Brouwer KLR, Hsu V, Nagar S, Matsson P, Sharma P, Snoeys J, Sugiyama Y, Tatosian D, Unadkat JD, Huang SM, Galetin A; International Transporter Consortium. Guo Y, et al. Among authors: sharma p. Clin Pharmacol Ther. 2018 Nov;104(5):865-889. doi: 10.1002/cpt.1183. Epub 2018 Sep 12. Clin Pharmacol Ther. 2018. PMID: 30059145 Free PMC article.
Recommendations for the Design of Clinical Drug-Drug Interaction Studies With Itraconazole Using a Mechanistic Physiologically-Based Pharmacokinetic Model.
Chen Y, Cabalu TD, Callegari E, Einolf H, Liu L, Parrott N, Peters SA, Schuck E, Sharma P, Tracey H, Upreti VV, Zheng M, Zhu AZX, Hall SD. Chen Y, et al. Among authors: sharma p. CPT Pharmacometrics Syst Pharmacol. 2019 Sep;8(9):685-695. doi: 10.1002/psp4.12449. Epub 2019 Aug 7. CPT Pharmacometrics Syst Pharmacol. 2019. PMID: 31215774 Free PMC article.
Physiologically-Based Pharmacokinetic Modeling in Renal and Hepatic Impairment Populations: A Pharmaceutical Industry Perspective.
Heimbach T, Chen Y, Chen J, Dixit V, Parrott N, Peters SA, Poggesi I, Sharma P, Snoeys J, Shebley M, Tai G, Tse S, Upreti VV, Wang YH, Tsai A, Xia B, Zheng M, Zhu AZX, Hall S. Heimbach T, et al. Among authors: sharma p. Clin Pharmacol Ther. 2021 Aug;110(2):297-310. doi: 10.1002/cpt.2125. Epub 2020 Dec 30. Clin Pharmacol Ther. 2021. PMID: 33270249 Free PMC article.
Streamlining Food Effect Assessment - Are Repeated Food Effect Studies Needed? An IQ Analysis.
Kesisoglou F, Basu S, Belubbi T, Bransford P, Chung J, Dodd S, Dolton M, Heimbach T, Kulkarni P, Lin W, Moir A, Parrott N, Pepin X, Ren X, Sharma P, Stamatopoulos K, Tistaert C, Vaidhyanathan S, Wagner C, Riedmaier AE. Kesisoglou F, et al. Among authors: sharma p. AAPS J. 2023 Jun 15;25(4):60. doi: 10.1208/s12248-023-00822-5. AAPS J. 2023. PMID: 37322223
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