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Considerations for Developing Targeted Therapies in Low-Frequency Molecular Subsets of a Disease.
Schuck RN, Woodcock J, Zineh I, Stein P, Jarow J, Temple R, Permutt T, LaVange L, Beaver JA, Charlab R, Blumenthal GM, Dorff SE, Leptak C, Lemery S, Rogers H, Chowdhury B, Litwack ED, Pacanowski M. Schuck RN, et al. Among authors: leptak c. Clin Pharmacol Ther. 2018 Aug;104(2):282-289. doi: 10.1002/cpt.1041. Epub 2018 Feb 23. Clin Pharmacol Ther. 2018. PMID: 29473145 Free PMC article. Review.
What evidence do we need for biomarker qualification?
Leptak C, Menetski JP, Wagner JA, Aubrecht J, Brady L, Brumfield M, Chin WW, Hoffmann S, Kelloff G, Lavezzari G, Ranganathan R, Sauer JM, Sistare FD, Zabka T, Wholley D. Leptak C, et al. Sci Transl Med. 2017 Nov 22;9(417):eaal4599. doi: 10.1126/scitranslmed.aal4599. Sci Transl Med. 2017. PMID: 29167393 Review.
Gaining Efficiency in Clinical Trials With Cardiac Biomarkers: JACC Review Topic of the Week.
Januzzi JL Jr, Canty JM, Das S, DeFilippi CR, Gintant GA, Gutstein DE, Jaffe A, Kaushik EP, Leptak C, Mehta C, Pina I, Povsic TJ, Rambaran C, Rhyne RF, Salas M, Shi VC, Udell JA, Unger EF, Zabka TS, Seltzer JH. Januzzi JL Jr, et al. Among authors: leptak c. J Am Coll Cardiol. 2021 Apr 20;77(15):1922-1933. doi: 10.1016/j.jacc.2021.02.040. J Am Coll Cardiol. 2021. PMID: 33858628 Free article. Review.
The FNIH Biomarkers Consortium embraces the BEST.
Menetski JP, Austin CP, Brady LS, Eakin G, Leptak C, Meltzer A, Wagner JA. Menetski JP, et al. Among authors: leptak c. Nat Rev Drug Discov. 2019 Jul;18(8):567-568. doi: 10.1038/d41573-019-00015-w. Nat Rev Drug Discov. 2019. PMID: 31367046 No abstract available.
16 results