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Michelle A. Rudek, Pharm.D., Ph.D.

Michelle A. Rudek, Pharm.D., Ph.D.

Headshot of Michelle A. Rudek
  • Professor of Oncology

Research Interests

Clinical pharmacology of anticancer agents; early phase drug development; drug tolerability in cancer patients with HIV/AIDS; drug tolerability in cancer patients with organ dysfunction; blood-brain barrier penetration of drugs. more


Michelle Rudek, Pharm.D., Ph.D., is an associate professor of oncology at the Johns Hopkins University School of Medicine and director of the Analytical Pharmacology Core for the Johns Hopkins Kimmel Cancer Center. 

Dr. Rudek studyies the pharmacokinetic-pharmacodynamic properties of anticancer agents, and her research is focused on oncology (preclinical studies and Phase I clinical trials/early phase drug development) and special populations within oncology (AIDS malignancy, and organ dysfunction). 

She received her Pharm.D. and Ph.D. from the Medical College of Virginia and joined the faculty at Johns Hopkins in 2001. more


  • Professor of Oncology
  • Professor of Medicine

Departments / Divisions

Centers & Institutes



  • B.S.; University of Pittsburgh (Pennsylvania) (1995)
  • Ph.D.; Virginia Commonwealth University (Virginia) (2001)
  • Pharm.D.; Virginia Commonwealth University (Virginia) (2001)

Research & Publications

Research Summary

Dr. Rudek is investigating the pharmacokinetic and pharmacodynamic behavior of anticncer gents and identify determinants that impact on the PK/PD variability of these agents with the hopes of individualizing therapy.

Clinical Trials

Learn more about clinical trials at the Johns Hopkins Kimmel Cancer Center.

Selected Publications

View all on PubMed

Rudek MA, Figg WD, Dyer V, Dahut W, Turner ML, Steinberg SM, Liewehr DJ, Kohler DR, Pluda JM, Reed E.  A phase I clinical trial of oral COL-3, a matrix metalloproteinase inhibitor, in patients with refractory metastatic cancer. J Clin Oncol. 2001;19(2):584-592.

Rudek MA, Zhao M, He P, Hartke C, Gilbert J, Gore SD, Carducci MA, Baker SD.  Pharmacokinetics of 5- azacytidine given with phenylbutyrate in patients with refractory solid tumors or hematologic malignancies.  J Clin Oncol.  2005;23(17):3906-3911.

Rudek MA, Flexner C, Ambinder RF.  Use of antineoplastic agents in cancer patients with HIV/AIDS.  Lancet Oncol. 2011;12(9):905-12.

Anders NA, Liu J, Wanjiku T, Giovinazzo H, Zhou J, Vaghasia A, Nelson WG, Yegnasubramanian S*, Rudek MA*. Simultaneous quantitative determination of 5-aza-2′-deoxycytidine genomic incorporation and DNA demethylation by liquid chromatography tandem mass spectrometry as exposure-response measures of nucleoside analog DNA methyltransferase inhibitors. J Chromatogr B Analyt Technol Biomed Life Sci. 2016;1022:38-45.

Mansfield AS*, Rudek MA*, Vulih D, Smith GL, Harris PJ, Ivy SP. The effect of hepatic impairment on outcomes in phase 1 clinical trials in cancer subjects. Clin Cancer Res. 2016 May 17. doi:10.1158/1078-0432.CCR-16-0449.

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