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Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (I) A Randomized Trial with PCSK9 Inhibitors.
Sheikhy M, Schrieber SJ, Sun Q, Gershuny V, Matta MK, Bai JPF, Du X, Vegesna G, Shah A, Prentice K, Nalepinski C, Zineh I, Wang YM, Strauss DG, Florian J. Sheikhy M, et al. Among authors: shah a. Clin Pharmacol Ther. 2023 Jan;113(1):71-79. doi: 10.1002/cpt.2769. Epub 2022 Nov 15. Clin Pharmacol Ther. 2023. PMID: 36282186 Clinical Trial.
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (II) A Randomized Trial with IL-5 Antagonists.
Gershuny V, Sun Q, Schrieber SJ, Matta MK, Weaver JL, Ji P, Sheikhy M, Hsiao CH, Vegesna G, Shah A, Prentice K, Deering J, Wang YM, Strauss DG, Florian J. Gershuny V, et al. Among authors: shah a. Clin Pharmacol Ther. 2023 Jan;113(1):80-89. doi: 10.1002/cpt.2760. Epub 2022 Oct 21. Clin Pharmacol Ther. 2023. PMID: 36184697 Clinical Trial.
Effect of Paroxetine or Quetiapine Combined With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia: A Randomized Clinical Trial.
Florian J, van der Schrier R, Gershuny V, Davis MC, Wang C, Han X, Burkhart K, Prentice K, Shah A, Racz R, Patel V, Matta M, Ismaiel OA, Weaver J, Boughner R, Ford K, Rouse R, Stone M, Sanabria C, Dahan A, Strauss DG. Florian J, et al. Among authors: shah a. JAMA. 2022 Oct 11;328(14):1405-1414. doi: 10.1001/jama.2022.17735. JAMA. 2022. PMID: 36219407 Free PMC article. Clinical Trial.
Considerations for Use of Pharmacodynamic Biomarkers to Support Biosimilar Development - (III) A Randomized Trial with Interferon Beta-1a Products.
Florian J, Gershuny V, Sun Q, Schrieber SJ, Matta MK, Hazel A, Sheikhy M, Weaver JL, Hyland PL, Hsiao CH, Vegesna G, DePalma R, Shah A, Prentice K, Sanabria C, Wang YM, Strauss DG. Florian J, et al. Among authors: shah a. Clin Pharmacol Ther. 2023 Feb;113(2):339-348. doi: 10.1002/cpt.2784. Epub 2022 Dec 2. Clin Pharmacol Ther. 2023. PMID: 36324229 Clinical Trial.
New science, drug regulation, and emergent public health issues: The work of FDA's division of applied regulatory science.
Chiu K, Racz R, Burkhart K, Florian J, Ford K, Iveth Garcia M, Geiger RM, Howard KE, Hyland PL, Ismaiel OA, Kruhlak NL, Li Z, Matta MK, Prentice KW, Shah A, Stavitskaya L, Volpe DA, Weaver JL, Wu WW, Rouse R, Strauss DG. Chiu K, et al. Among authors: shah a. Front Med (Lausanne). 2023 Jan 19;9:1109541. doi: 10.3389/fmed.2022.1109541. eCollection 2022. Front Med (Lausanne). 2023. PMID: 36743666 Free PMC article. Review.
Intranasal Naloxone Repeat Dosing Strategies and Fentanyl Overdose: A Simulation-Based Randomized Clinical Trial.
Strauss DG, Li Z, Chaturbedi A, Chakravartula S, Samieegohar M, Mann J, Nallani SC, Prentice K, Shah A, Burkhart K, Boston J, Fu YA, Dahan A, Zineh I, Florian JA. Strauss DG, et al. Among authors: shah a. JAMA Netw Open. 2024 Jan 2;7(1):e2351839. doi: 10.1001/jamanetworkopen.2023.51839. JAMA Netw Open. 2024. PMID: 38261323 Free PMC article. Clinical Trial.
Early evaluation of risk stratification and clinical outcomes for patients with advanced breast cancer through combined monitoring of baseline circulating tumor cells and DNA.
Zhang Q, Cai Z, Gerratana L, Davis AA, D'Amico P, Chawla A, Jacob S, Zhang Y, Jiao J, Qin W, Reduzzi C, Flaum L, Shah A, Gradishar W. Zhang Q, et al. Among authors: shah a. Clin Cancer Res. 2024 Jun 3. doi: 10.1158/1078-0432.CCR-24-0535. Online ahead of print. Clin Cancer Res. 2024. PMID: 38829582
Erratum: Scaling up the task-sharing of psychological therapies: A formative study of the PEERS smartphone application for supervision and quality assurance in rural India - CORRIGENDUM.
Singla DR, Fernandes L, Savel K, Shah A, Agrawal R, Bhan A, Nadkarni A, Sharma A, Khan A, Lahiri A, Tugnawat D, Lesh N, Patel V, Naslund J. Singla DR, et al. Among authors: shah a. Glob Ment Health (Camb). 2024 May 30;11:e65. doi: 10.1017/gmh.2024.61. eCollection 2024. Glob Ment Health (Camb). 2024. PMID: 38827332 Free PMC article.
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