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Accelerating drug development in pediatric cancer: a novel Phase I study design of venetoclax in relapsed/refractory malignancies.

Place AE, Goldsmith K, Bourquin JP, Loh ML, Gore L, Morgenstern DA, Sanzgiri Y, Hoffman D, Zhou Y, Ross JA, Prine B, Shebley M, McNamee M, Farazi T, Kim SY, Verdugo M, Lash-Fleming L, Zwaan CM, Vormoor J. Place AE, et al. Among authors: shebley m. Future Oncol. 2018 Sep;14(21):2115-2129. doi: 10.2217/fon-2018-0121. Epub 2018 Mar 29. Future Oncol. 2018. PMID: 29595064 Free article. Clinical Trial.

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Clinical Pharmacology of Elagolix: An Oral Gonadotropin-Releasing Hormone Receptor Antagonist for Endometriosis.

Shebley M, Polepally AR, Nader A, Ng JW, Winzenborg I, Klein CE, Noertersheuser P, Gibbs MA, Mostafa NM. Shebley M, et al. Clin Pharmacokinet. 2020 Mar;59(3):297-309. doi: 10.1007/s40262-019-00840-7. Clin Pharmacokinet. 2020. PMID: 31749075 Free PMC article. Review.

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Industry Perspective on Standardizing Food-Effect Studies for New Drug Development.

Marroum PJ, Nuthalapati S, Parikh A, Shebley M, Hoffman D, Zha J, Khatri A, Awni WM. Marroum PJ, et al. Among authors: shebley m. Clin Pharmacokinet. 2018 Aug;57(8):901-909. doi: 10.1007/s40262-018-0630-0. Clin Pharmacokinet. 2018. PMID: 29460023 Review.

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Practical Assessment of Clinical Drug-Drug Interactions in Drug Development Using Physiologically Based Pharmacokinetics Modeling.

Shebley M, Einolf HJ. Shebley M, et al. Clin Pharmacol Ther. 2019 Jun;105(6):1326-1328. doi: 10.1002/cpt.1394. Epub 2019 Mar 20. Clin Pharmacol Ther. 2019. PMID: 30893473 Review. No abstract available.

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Assessment of Clinical Drug-Drug Interactions of Elagolix, a Gonadotropin-Releasing Hormone Receptor Antagonist.

Polepally AR, Ng JW, Salem AH, Dufek MB, Parikh A, Carter DC, Kamradt K, Mostafa NM, Shebley M. Polepally AR, et al. Among authors: shebley m. J Clin Pharmacol. 2020 Dec;60(12):1606-1616. doi: 10.1002/jcph.1689. Epub 2020 Jul 7. J Clin Pharmacol. 2020. PMID: 33045114 Free PMC article.

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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: shebley m. Clin Pharmacol Ther. 2021 Aug;110(2):297-310. doi: 10.1002/cpt.2125. Epub 2020 Dec 30. Clin Pharmacol Ther. 2021. PMID: 33270249

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A Personalized Medicine Approach Using Clinical Utility Index and Exposure-Response Modeling Informed by Patient Preferences Data.

Winzenborg I, Soliman AM, Shebley M. Winzenborg I, et al. Among authors: shebley m. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):40-47. doi: 10.1002/psp4.12570. Epub 2020 Dec 18. CPT Pharmacometrics Syst Pharmacol. 2021. PMID: 33200566 Free PMC article.

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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. 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.

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Quantitative Assessment of Elagolix Enzyme-Transporter Interplay and Drug-Drug Interactions Using Physiologically Based Pharmacokinetic Modeling.

Chiney MS, Ng J, Gibbs JP, Shebley M. Chiney MS, et al. Among authors: shebley m. Clin Pharmacokinet. 2020 May;59(5):617-627. doi: 10.1007/s40262-019-00833-6. Clin Pharmacokinet. 2020. PMID: 31713224 Free PMC article.

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Accelerating Drug Development in Pediatric Oncology With the Clinical Pharmacology Storehouse.

Shebley M, Menon RM, Gibbs JP, Dave N, Kim SY, Marroum PJ. Shebley M, et al. J Clin Pharmacol. 2019 May;59(5):625-637. doi: 10.1002/jcph.1359. Epub 2018 Dec 18. J Clin Pharmacol. 2019. PMID: 30562405 Free PMC article. Review.

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