Kerwash E - Search Results

1

The European Medicines Agency Review of Kymriah (Tisagenlecleucel) for the Treatment of Acute Lymphoblastic Leukemia and Diffuse Large B-Cell Lymphoma.

Ali S, Kjeken R, Niederlaender C, Markey G, Saunders TS, Opsata M, Moltu K, Bremnes B, Grønevik E, Muusse M, Håkonsen GD, Skibeli V, Kalland ME, Wang I, Buajordet I, Urbaniak A, Johnston J, Rantell K, Kerwash E, Schuessler-Lenz M, Salmonson T, Bergh J, Gisselbrecht C, Tzogani K, Papadouli I, Pignatti F. Ali S, et al. Among authors: kerwash e. Oncologist. 2020 Feb;25(2):e321-e327. doi: 10.1634/theoncologist.2019-0233. Epub 2019 Oct 16. Oncologist. 2020. PMID: 32043764 Free PMC article. Review.

2

A summary of the current drug interaction guidance from the European Medicines Agency and considerations of future updates.

Cole S, Kerwash E, Andersson A. Cole S, et al. Among authors: kerwash e. Drug Metab Pharmacokinet. 2020 Feb;35(1):2-11. doi: 10.1016/j.dmpk.2019.11.005. Epub 2020 Jan 8. Drug Metab Pharmacokinet. 2020. PMID: 31996310 Review.

3

A review of clinical pharmacology deficiencies of European centralised drug marketing authorisation applications.

Hay JL, O'Sullivan J, Kerwash E, Ilie AR, Cole SM. Hay JL, et al. Among authors: kerwash e. Regul Toxicol Pharmacol. 2020 Dec;118:104804. doi: 10.1016/j.yrtph.2020.104804. Epub 2020 Oct 10. Regul Toxicol Pharmacol. 2020. PMID: 33049309 Review.

4

Pharmacokinetic Characterization to Enable Medicine Use in Pregnancy, the Potential Role of Physiologically-Based Pharmacokinetic Modeling: A Regulatory Perspective.

Cole S, Coppola P, Kerwash E, Nooney J, Lam SP. Cole S, et al. Among authors: kerwash e. CPT Pharmacometrics Syst Pharmacol. 2020 Oct;9(10):547-549. doi: 10.1002/psp4.12551. Epub 2020 Aug 27. CPT Pharmacometrics Syst Pharmacol. 2020. PMID: 32741152 Free PMC article. No abstract available.

5

Commentary on the MID3 Good Practices Paper.

Manolis E, Brogren J, Cole S, Hay JL, Nordmark A, Karlsson KE, Lentz F, Benda N, Wangorsch G, Pons G, Zhao W, Gigante V, Serone F, Standing JF, Dokoumetzidis A, Vakkilainen J, van den Heuvel M, Mangas Sanjuan V, Taminiau J, Kerwash E, Khan D, Musuamba FT, Skottheim Rusten I; EMA Modelling and Simulation Working Group. Manolis E, et al. Among authors: kerwash e. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):416-417. doi: 10.1002/psp4.12223. Epub 2017 Jul 22. CPT Pharmacometrics Syst Pharmacol. 2017. PMID: 28653481 Free PMC article.

6

The Use of Pregnancy Physiologically Based Pharmacokinetic Modeling for Renally Cleared Drugs.

Coppola P, Kerwash E, Cole S. Coppola P, et al. Among authors: kerwash e. J Clin Pharmacol. 2022 Sep;62 Suppl 1:S129-S139. doi: 10.1002/jcph.2110. J Clin Pharmacol. 2022. PMID: 36106785

7

Pharmacokinetic data in pregnancy: A review of available literature data and important considerations in collecting clinical data.

Coppola P, Kerwash E, Nooney J, Omran A, Cole S. Coppola P, et al. Among authors: kerwash e. Front Med (Lausanne). 2022 Oct 4;9:940644. doi: 10.3389/fmed.2022.940644. eCollection 2022. Front Med (Lausanne). 2022. PMID: 36267613 Free PMC article. Review.

8

Physiologically Based Pharmacokinetics Model in Pregnancy: A Regulatory Perspective on Model Evaluation.

Coppola P, Kerwash E, Cole S. Coppola P, et al. Among authors: kerwash e. Front Pediatr. 2021 Jun 23;9:687978. doi: 10.3389/fped.2021.687978. eCollection 2021. Front Pediatr. 2021. PMID: 34249817 Free PMC article.

9

Use of Physiologically Based Pharmacokinetic Modeling for Hepatically Cleared Drugs in Pregnancy: Regulatory Perspective.

Coppola P, Kerwash E, Cole S. Coppola P, et al. Among authors: kerwash e. J Clin Pharmacol. 2023 Jun;63 Suppl 1:S62-S80. doi: 10.1002/jcph.2266. J Clin Pharmacol. 2023. PMID: 37317504

10

Total and Free Blood and Plasma Concentration Changes in Pregnancy for Medicines Highly Bound to Plasma Proteins: Application of Physiologically Based Pharmacokinetic Modelling to Understand the Impact on Efficacy.

Coppola P, Butler A, Cole S, Kerwash E. Coppola P, et al. Among authors: kerwash e. Pharmaceutics. 2023 Oct 13;15(10):2455. doi: 10.3390/pharmaceutics15102455. Pharmaceutics. 2023. PMID: 37896215 Free PMC article.

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