Kweder SL - Search Results

1

A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014-2016: Concordance, Discordance, and Why.

Kashoki M, Hanaizi Z, Yordanova S, Veselý R, Bouygues C, Llinares J, Kweder SL. Kashoki M, et al. Among authors: kweder sl. Clin Pharmacol Ther. 2020 Jan;107(1):195-202. doi: 10.1002/cpt.1565. Epub 2019 Aug 14. Clin Pharmacol Ther. 2020. PMID: 31306483 Free PMC article.

2

Females in clinical studies: where are we going?

Uhl K, Parekh A, Kweder S. Uhl K, et al. Clin Pharmacol Ther. 2007 Apr;81(4):600-2. doi: 10.1038/sj.clpt.6100112. Epub 2007 Feb 21. Clin Pharmacol Ther. 2007. PMID: 17314925

3

Drug shortages: the cycle of quantity and quality.

Kweder SL, Dill S. Kweder SL, et al. Clin Pharmacol Ther. 2013 Mar;93(3):245-51. doi: 10.1038/clpt.2012.235. Epub 2012 Dec 6. Clin Pharmacol Ther. 2013. PMID: 23340474

4

Regional Approaches to Expedited Drug Development and Review: Can Regulatory Harmonization Improve Outcomes?

Richardson E, Daniel G, Joy DR, Kweder SL, Maloney DM, Raggio MJ, Jarow JP. Richardson E, et al. Among authors: kweder sl. Ther Innov Regul Sci. 2018 Nov;52(6):793-798. doi: 10.1177/2168479018764664. Epub 2018 Apr 8. Ther Innov Regul Sci. 2018. PMID: 29714587

5

Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?

Teixeira T, Kweder SL, Saint-Raymond A. Teixeira T, et al. Among authors: kweder sl. Clin Pharmacol Ther. 2020 Mar;107(3):507-513. doi: 10.1002/cpt.1617. Epub 2019 Oct 24. Clin Pharmacol Ther. 2020. PMID: 31449664 Free PMC article. Review.

6

Remdesivir emergency approvals: a comparison of the U.S., Japanese, and EU systems.

Saint-Raymond A, Sato J, Kishioka Y, Teixeira T, Hasslboeck C, Kweder SL. Saint-Raymond A, et al. Among authors: kweder sl. Expert Rev Clin Pharmacol. 2020 Oct;13(10):1095-1101. doi: 10.1080/17512433.2020.1821650. Epub 2020 Sep 29. Expert Rev Clin Pharmacol. 2020. PMID: 32909843 Review.

7

Assuring Access to Safe Medicines in Pregnancy and Breastfeeding.

Nooney J, Thor S, de Vries C, Clements J, Sahin L, Hua W, Everett D, Zaccaria C, Ball R, Saint-Raymond A, Yao L, Raine J, Kweder S. Nooney J, et al. Clin Pharmacol Ther. 2021 Oct;110(4):941-945. doi: 10.1002/cpt.2212. Epub 2021 May 1. Clin Pharmacol Ther. 2021. PMID: 33615448 Free PMC article. Review.

8

A Comparison of FDA and EMA Pregnancy and Lactation Labeling.

Kappel D, Sahin L, Yao L, Thor S, Kweder S. Kappel D, et al. Clin Pharmacol Ther. 2023 Jun;113(6):1251-1257. doi: 10.1002/cpt.2843. Epub 2023 Feb 5. Clin Pharmacol Ther. 2023. PMID: 36645246

9

Risk management strategies in the Physicians' Desk Reference product labels for pregnancy category X drugs.

Uhl K, Kennedy DL, Kweder SL. Uhl K, et al. Among authors: kweder sl. Drug Saf. 2002;25(12):885-92. doi: 10.2165/00002018-200225120-00006. Drug Saf. 2002. PMID: 12241129

10

Accurate information on drug effects on pregnancy is crucial.

Uhl K, Kennedy DL, Kweder SL. Uhl K, et al. Among authors: kweder sl. Am Fam Physician. 2003 Feb 15;67(4):700-1; author reply 702. Am Fam Physician. 2003. PMID: 12613724 Free article. No abstract available.

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