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A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of a Respiratory Syncytial Virus Neutralizing Monoclonal Antibody MK-1654 in Healthy Adults.
Aliprantis AO, Wolford D, Caro L, Maas BM, Ma H, Montgomery DL, Sterling LM, Hunt A, Cox KS, Vora KA, Roadcap BA, Railkar RA, Lee AW, Stoch SA, Lai E. Aliprantis AO, et al. Among authors: railkar ra. Clin Pharmacol Drug Dev. 2021 May;10(5):556-566. doi: 10.1002/cpdd.883. Epub 2020 Oct 30. Clin Pharmacol Drug Dev. 2021. PMID: 33125189 Clinical Trial.
A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.
Aliprantis AO, Shaw CA, Griffin P, Farinola N, Railkar RA, Cao X, Liu W, Sachs JR, Swenson CJ, Lee H, Cox KS, Spellman DS, Winstead CJ, Smolenov I, Lai E, Zaks T, Espeseth AS, Panther L. Aliprantis AO, et al. Among authors: railkar ra. Hum Vaccin Immunother. 2021 May 4;17(5):1248-1261. doi: 10.1080/21645515.2020.1829899. Epub 2020 Oct 29. Hum Vaccin Immunother. 2021. PMID: 33121346 Free PMC article. Clinical Trial.
Forward and reverse translational approaches to predict efficacy of neutralizing respiratory syncytial virus (RSV) antibody prophylaxis.
Maas BM, Lommerse J, Plock N, Railkar RA, Cheung SYA, Caro L, Chen J, Liu W, Zhang Y, Huang Q, Gao W, Qin L, Meng J, Witjes H, Schindler E, Guiastrennec B, Bellanti F, Spellman DS, Roadcap B, Kalinova M, Fok-Seang J, Catchpole AP, Espeseth AS, Stoch SA, Lai E, Vora KA, Aliprantis AO, Sachs JR. Maas BM, et al. Among authors: railkar ra. EBioMedicine. 2021 Nov;73:103651. doi: 10.1016/j.ebiom.2021.103651. Epub 2021 Nov 11. EBioMedicine. 2021. PMID: 34775220 Free PMC article.
Fine-Needle Aspiration for the Evaluation of Hepatic Pharmacokinetics of Vaniprevir: A Randomized Trial in Patients With Hepatitis C Virus Infection.
Gao W, Webber AL, Maxwell J, Anderson M, Caro L, Chung C, Miltenburg AMM, Popa S, Van Dyck K, Wenning L, Mangin E, Fandozzi C, Railkar R, Shire NJ, Fraser I, Howell B, Talal AH, Stoch SA. Gao W, et al. Clin Pharmacol Ther. 2020 Jun;107(6):1325-1333. doi: 10.1002/cpt.1737. Epub 2020 Feb 8. Clin Pharmacol Ther. 2020. PMID: 31868916 Clinical Trial.
"In-House" Data on the Outside-A Mobile Health Approach.
Huang Q, Crumley T, Walters C, Cluckers L, Heirman I, Railkar R, Bhatia G, Cantor M, Benko C, Izmailova ES, Rottey S, Stoch SA. Huang Q, et al. Clin Pharmacol Ther. 2020 Apr;107(4):948-956. doi: 10.1002/cpt.1790. Epub 2020 Mar 7. Clin Pharmacol Ther. 2020. PMID: 31955410 Clinical Trial.
Validation of a microdose probe drug cocktail for clinical drug interaction assessments for drug transporters and CYP3A.
Prueksaritanont T, Tatosian DA, Chu X, Railkar R, Evers R, Chavez-Eng C, Lutz R, Zeng W, Yabut J, Chan GH, Cai X, Latham AH, Hehman J, Stypinski D, Brejda J, Zhou C, Thornton B, Bateman KP, Fraser I, Stoch SA. Prueksaritanont T, et al. Clin Pharmacol Ther. 2017 Apr;101(4):519-530. doi: 10.1002/cpt.525. Epub 2016 Dec 10. Clin Pharmacol Ther. 2017. PMID: 27943276 Clinical Trial.
An accessible pharmacodynamic transcriptional biomarker for notch target engagement.
Tanis KQ, Podtelezhnikov AA, Blackman SC, Hing J, Railkar RA, Lunceford J, Klappenbach JA, Wei B, Harman A, Camargo LM, Shah S, Finney EM, Hardwick JS, Loboda A, Watters J, Bergstrom DA, Demuth T, Herman GA, Strack PR, Iannone R. Tanis KQ, et al. Among authors: railkar ra. Clin Pharmacol Ther. 2016 Apr;99(4):370-80. doi: 10.1002/cpt.335. Epub 2016 Feb 17. Clin Pharmacol Ther. 2016. PMID: 26765077 Clinical Trial.
Leveraging a Clinical Phase Ib Proof-of-Concept Study for the GPR40 Agonist MK-8666 in Patients With Type 2 Diabetes for Model-Informed Phase II Dose Selection.
Krug AW, Vaddady P, Railkar RA, Musser BJ, Cote J, Ederveen A, Krefetz DG, DeNoia E, Free AL, Morrow L, Chakravarthy MV, Kauh E, Tatosian DA, Kothare PA. Krug AW, et al. Among authors: railkar ra. Clin Transl Sci. 2017 Sep;10(5):404-411. doi: 10.1111/cts.12479. Epub 2017 Jul 20. Clin Transl Sci. 2017. PMID: 28727908 Free PMC article. Clinical Trial.
Immune response and reactogenicity of intradermal administration versus subcutaneous administration of varicella-zoster virus vaccine: an exploratory, randomised, partly blinded trial.
Beals CR, Railkar RA, Schaeffer AK, Levin Y, Kochba E, Meyer BK, Evans RK, Sheldon EA, Lasseter K, Lang N, Weinberg A, Canniff J, Levin MJ. Beals CR, et al. Among authors: railkar ra. Lancet Infect Dis. 2016 Aug;16(8):915-22. doi: 10.1016/S1473-3099(16)00133-X. Epub 2016 Apr 6. Lancet Infect Dis. 2016. PMID: 27061887 Clinical Trial.
38 results