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Clinical pharmacology as a cornerstone of orphan drug development.
Bashaw ED, Huang SM, Coté TR, Pariser AR, Garnett CE, Burckart G, Zhang L, Men AY, Le CD, Charlab R, Gobburu JV, Lesko LJ. Bashaw ED, et al. Among authors: charlab r. Nat Rev Drug Discov. 2011 Oct 31;10(11):795-6. doi: 10.1038/nrd3595. Nat Rev Drug Discov. 2011. PMID: 22037026
Leveraging Genomic Factors to Improve Benefit-Risk.
Schuck RN, Charlab R, Blumenthal GM. Schuck RN, et al. Among authors: charlab r. Clin Transl Sci. 2017 Mar;10(2):78-83. doi: 10.1111/cts.12439. Epub 2017 Feb 3. Clin Transl Sci. 2017. PMID: 28160443 Free PMC article. Review. No abstract available.
FDA Approval Summary: Selpercatinib for the Treatment of Lung and Thyroid Cancers with RET Gene Mutations or Fusions.
Bradford D, Larkins E, Mushti SL, Rodriguez L, Skinner AM, Helms WS, Price LSL, Zirkelbach JF, Li Y, Liu J, Charlab R, Turcu FR, Liang D, Ghosh S, Roscoe D, Philip R, Zack-Taylor A, Tang S, Kluetz PG, Beaver JA, Pazdur R, Theoret MR, Singh H. Bradford D, et al. Among authors: charlab r. Clin Cancer Res. 2021 Apr 15;27(8):2130-2135. doi: 10.1158/1078-0432.CCR-20-3558. Epub 2020 Nov 25. Clin Cancer Res. 2021. PMID: 33239432
FDA Approval Summary: Pralsetinib for the Treatment of Lung and Thyroid Cancers With RET Gene Mutations or Fusions.
Kim J, Bradford D, Larkins E, Pai-Scherf LH, Chatterjee S, Mishra-Kalyani PS, Wearne E, Helms WS, Ayyoub A, Bi Y, Sun J, Charlab R, Liu J, Zhao H, Liang D, Ghosh S, Philip R, Pazdur R, Theoret MR, Beaver JA, Singh H. Kim J, et al. Among authors: charlab r. Clin Cancer Res. 2021 Oct 15;27(20):5452-5456. doi: 10.1158/1078-0432.CCR-21-0967. Epub 2021 May 27. Clin Cancer Res. 2021. PMID: 34045295
64 results