Pacanowski M - Search Results

1

Personalized Cardiovascular Medicine Today: A Food and Drug Administration/Center for Drug Evaluation and Research Perspective.

Blaus A, Madabushi R, Pacanowski M, Rose M, Schuck RN, Stockbridge N, Temple R, Unger EF. Blaus A, et al. Among authors: pacanowski m. Circulation. 2015 Oct 13;132(15):1425-32. doi: 10.1161/CIRCULATIONAHA.114.009761. Circulation. 2015. PMID: 26459078

2

Pharmacogenomics in the assessment of therapeutic risks versus benefits: inside the United States Food and Drug Administration.

Zineh I, Pacanowski MA. Zineh I, et al. Pharmacotherapy. 2011 Aug;31(8):729-35. doi: 10.1592/phco.31.8.729. Pharmacotherapy. 2011. PMID: 21923598

3

Biomarkers to improve the benefit/risk balance for approved therapeutics: a US FDA perspective on personalized medicine.

Sapsford KE, Tezak Z, Kondratovich M, Pacanowski MA, Zineh I, Mansfield E. Sapsford KE, et al. Among authors: pacanowski ma. Ther Deliv. 2010 Nov;1(5):631-41. doi: 10.4155/tde.10.62. Ther Deliv. 2010. PMID: 22833953

4

Next-generation medicines: past regulatory experience and considerations for the future.

Pacanowski MA, Leptak C, Zineh I. Pacanowski MA, et al. Clin Pharmacol Ther. 2014 Mar;95(3):247-9. doi: 10.1038/clpt.2013.222. Clin Pharmacol Ther. 2014. PMID: 24548989 Review.

5

Effectiveness of clopidogrel dose escalation to normalize active metabolite exposure and antiplatelet effects in CYP2C19 poor metabolizers.

Horenstein RB, Madabushi R, Zineh I, Yerges-Armstrong LM, Peer CJ, Schuck RN, Figg WD, Shuldiner AR, Pacanowski MA. Horenstein RB, et al. Among authors: pacanowski ma. J Clin Pharmacol. 2014 Aug;54(8):865-73. doi: 10.1002/jcph.293. Epub 2014 Apr 7. J Clin Pharmacol. 2014. PMID: 24710841 Free PMC article. Clinical Trial.

6

Trial geography, pharmacogenetics, and global drug development.

Schuck RN, Florian J, Charlab R, Pacanowski M. Schuck RN, et al. Among authors: pacanowski m. Clin Pharmacol Ther. 2015 Mar;97(3):218-20. doi: 10.1002/cpt.27. Epub 2014 Dec 15. Clin Pharmacol Ther. 2015. PMID: 25669642

7

Precision Medicine.

Pacanowski M, Huang SM. Pacanowski M, et al. Clin Pharmacol Ther. 2016 Feb;99(2):124-9. doi: 10.1002/cpt.296. Clin Pharmacol Ther. 2016. PMID: 26800326 No abstract available.

8

Clinical and regulatory considerations in pharmacogenetic testing.

Schuck RN, Marek E, Rogers H, Pacanowski M. Schuck RN, et al. Among authors: pacanowski m. Am J Health Syst Pharm. 2016 Dec 1;73(23):1999-2006. doi: 10.2146/ajhp160476. Am J Health Syst Pharm. 2016. PMID: 27864207 Free PMC article. Review.

9

Enrichment Strategies in Pediatric Drug Development: An Analysis of Trials Submitted to the US Food and Drug Administration.

Green DJ, Liu XI, Hua T, Burnham JM, Schuck R, Pacanowski M, Yao L, McCune SK, Burckart GJ, Zineh I. Green DJ, et al. Among authors: pacanowski m. Clin Pharmacol Ther. 2018 Nov;104(5):983-988. doi: 10.1002/cpt.971. Epub 2018 Feb 13. Clin Pharmacol Ther. 2018. PMID: 29218740 Free PMC article.

10

Regulatory policy for the development of targeted therapies for low-frequency molecular subtypes of disease.

Schuck RN, Pacanowski M, Woodcock J, Zineh I. Schuck RN, et al. Among authors: pacanowski m. Nat Rev Drug Discov. 2018 Feb;17(2):79-80. doi: 10.1038/nrd.2017.231. Epub 2017 Dec 22. Nat Rev Drug Discov. 2018. PMID: 29269943 No abstract available.

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