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Evaluation of model-based bioequivalence approach for single sample pharmacokinetic studies.
Tardivon C, Loingeville F, Donnelly M, Feng K, Sun W, Sun G, Grosser S, Zhao L, Fang L, Mentré F, Bertrand J. Tardivon C, et al. Among authors: donnelly m. CPT Pharmacometrics Syst Pharmacol. 2023 Jul;12(7):904-915. doi: 10.1002/psp4.12960. Epub 2023 Apr 27. CPT Pharmacometrics Syst Pharmacol. 2023. PMID: 37114321 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. 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.
Considerations for the Forced Expiratory Volume in 1 Second-Based Comparative Clinical Endpoint Bioequivalence Studies for Orally Inhaled Drug Products.
Lee J, Feng K, Conti DS, Walenga R, Wientjes M, Wang H, Newman B, Han L, Dhapare S, Bielski E, Babiskin A, Wu F, Donnelly M, Kim MJ, Jiang W, Luke MC, Fang L, Zhao L. Lee J, et al. Among authors: donnelly m. Clin Pharmacol Ther. 2022 Nov;112(5):982-989. doi: 10.1002/cpt.2553. Epub 2022 Mar 7. Clin Pharmacol Ther. 2022. PMID: 35133652 Review.
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: donnelly m. 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.
Narrow Therapeutic Index Drugs: FDA Experience, Views, and Operations.
Donnelly M, Fang L, Madabushi R, Zhu H, Luke M, Canterbury C, Lerman B, Kaur P, Patel D, Sun W, Schuirmann D, Dinsmore S, Mehta M, Zhao L. Donnelly M, et al. Clin Pharmacol Ther. 2025 Jan;117(1):116-129. doi: 10.1002/cpt.3460. Epub 2024 Nov 11. Clin Pharmacol Ther. 2025. PMID: 39529254 Review.
A systematic review of interventions targeting Anopheles stephensi.
Doumbe Belisse P, Reynolds AM, Weetman D, Wilson AL, Donnelly MJ. Doumbe Belisse P, et al. Among authors: donnelly mj. Wellcome Open Res. 2024 Dec 16;9:724. doi: 10.12688/wellcomeopenres.23480.1. eCollection 2024. Wellcome Open Res. 2024. PMID: 39844918 Free PMC article.
1,284 results