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A pharmacokinetics and pharmacodynamics equivalence trial of the proposed pegfilgrastim biosimilar, MYL-1401H, versus reference pegfilgrastim.
Waller CF, Tiessen RG, Lawrence TE, Shaw A, Liu MS, Sharma R, Baczkowski M, Kothekar MA, Micales CE, Barve A, Ranganna GM, Pennella EJ. Waller CF, et al. Among authors: liu ms. J Cancer Res Clin Oncol. 2018 Jun;144(6):1087-1095. doi: 10.1007/s00432-018-2643-3. Epub 2018 Apr 18. J Cancer Res Clin Oncol. 2018. PMID: 29671069 Clinical Trial.
A pharmacokinetics phase 1 bioequivalence study of the trastuzumab biosimilar MYL-1401O vs. EU-trastuzumab and US-trastuzumab.
Waller CF, Vutikullird A, Lawrence TE, Shaw A, Liu MS, Baczkowski M, Sharma R, Barve A, Goyal P, Donnelly C, Sengupta N, Pennella EJ. Waller CF, et al. Among authors: liu ms. Br J Clin Pharmacol. 2018 Oct;84(10):2336-2343. doi: 10.1111/bcp.13689. Epub 2018 Jul 31. Br J Clin Pharmacol. 2018. PMID: 29926514 Free PMC article. Clinical Trial.
Pharmacokinetic and pharmacodynamic bioequivalence of biosimilar MYL-1601D with US and European insulin aspart in healthy volunteers: A randomized, double-blind, crossover, euglycaemic glucose clamp study.
Hövelmann U, Raiter Y, Chullikana A, Liu M, Donnelly C, Lawrence T, Sengupta N, Cl G, Ranganna G, Barve A. Hövelmann U, et al. Diabetes Obes Metab. 2021 Dec;23(12):2670-2678. doi: 10.1111/dom.14519. Epub 2021 Aug 25. Diabetes Obes Metab. 2021. PMID: 34378861 Free PMC article. Clinical Trial.
Bioequivalence Studies of Sildenafil Citrate Orodispersible Film Administered with and without Water vs ViagraⓇ Film-Coated Tablets in Healthy Male Volunteers.
Shaw A, Lawrence TE, Yan T, Liu M, Summers N, Daggumati V, Austria ST, Rondon JC, Hackley S, Vignesh SO, Hassan TA. Shaw A, et al. Curr Ther Res Clin Exp. 2023 Jun 9;99:100708. doi: 10.1016/j.curtheres.2023.100708. eCollection 2023. Curr Ther Res Clin Exp. 2023. PMID: 37435189 Free PMC article.
Population Pharmacokinetics of MYL-1402O, a Proposed Biosimilar to Bevacizumab and Reference Product (Avastin®) in Patients with Non-squamous Non-small Cell Lung Cancer.
Owen JS, Rackley RJ, Hummel MA, Roepcke S, Huang H, Liu M, Idris TA, Murugesan SMN, Marwah A, Loganathan S, Ranganna G, Barve A, Waller CF, Socinski MA. Owen JS, et al. Eur J Drug Metab Pharmacokinet. 2023 Nov;48(6):675-689. doi: 10.1007/s13318-023-00855-3. Epub 2023 Oct 4. Eur J Drug Metab Pharmacokinet. 2023. PMID: 37792130 Clinical Trial.
The Comparative Bioavailability of Fluticasone and Azelastine Delivered as a Single Fixed Dose Combination (MP-AzeFlu) in Comparison to Two Different Formulations of Azelastine and Fluticasone Propionate Following Intranasal Administration in Healthy Chinese Volunteers.
Qi W, Liu Y, Xue W, Li K, Gorski JC, Liu M, Yan T, Nguyen DT, Ramalingam RK. Qi W, et al. J Asthma Allergy. 2023 Jun 30;16:667-677. doi: 10.2147/JAA.S416095. eCollection 2023. J Asthma Allergy. 2023. PMID: 37409000 Free PMC article.
380 results