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Efficient model-based bioequivalence testing.
Möllenhoff K, Loingeville F, Bertrand J, Nguyen TT, Sharan S, Zhao L, Fang L, Sun G, Grosser S, Mentré F, Dette H. Möllenhoff K, et al. Among authors: sharan s. Biostatistics. 2022 Jan 13;23(1):314-327. doi: 10.1093/biostatistics/kxaa026. Biostatistics. 2022. PMID: 32696053
Impact of model misspecification on model-based tests in PK studies with parallel design: real case and simulation studies.
Guhl M, Mercier F, Hofmann C, Sharan S, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Comets E, Bertrand J. Guhl M, et al. Among authors: sharan s. J Pharmacokinet Pharmacodyn. 2022 Oct;49(5):557-577. doi: 10.1007/s10928-022-09821-z. Epub 2022 Sep 16. J Pharmacokinet Pharmacodyn. 2022. PMID: 36112338 Free PMC article.
Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions.
Donnelly M, Tsakalozou E, Sharan S, Straubinger T, Bies R, Zhao L. Donnelly M, et al. Among authors: sharan s. J Clin Pharmacol. 2020 Dec;60 Suppl 2:S26-S33. doi: 10.1002/jcph.1760. J Clin Pharmacol. 2020. PMID: 33274513 Review. No abstract available.
Applications of Physiologically Based Biopharmaceutics Modeling (PBBM) to Support Drug Product Quality: A Workshop Summary Report.
Mitra A, Suarez-Sharp S, Pepin XJH, Flanagan T, Zhao Y, Kotzagiorgis E, Parrott N, Sharan S, Tistaert C, Heimbach T, Zolnik B, Sjögren E, Wu F, Anand O, Kakar S, Li M, Veerasingham S, Kijima S, Lima Santos GM, Ning B, Raines K, Rullo G, Mandula H, Delvadia P, Dressman J, Dickinson PA, Babiskin A. Mitra A, et al. Among authors: sharan s. J Pharm Sci. 2021 Feb;110(2):594-609. doi: 10.1016/j.xphs.2020.10.059. Epub 2020 Nov 3. J Pharm Sci. 2021. PMID: 33152375
232 results