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Current Industry Best Practice on in-use Stability and Compatibility Studies for Biological Products.
Blümel M, Liu J, de Jong I, Weiser S, Fast J, Litowski J, Shuman M, Mehta SB, Amery L, Tan DCT, Jia F, Shekhawat D, Dagallier C, Emamzadeh M, Medina A, Santos C, Gasser F, Urban C. Blümel M, et al. Among authors: mehta sb. J Pharm Sci. 2023 Sep;112(9):2332-2346. doi: 10.1016/j.xphs.2023.05.002. Epub 2023 May 7. J Pharm Sci. 2023. PMID: 37160227 Review.
Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.
Zamiri C, Leiske DL, Hughes PF, Kirwan JP, Der E, Cox E, Warburton R, Goss M, Weiser S, Perez-Brown J, Gopalrathnam G, Liu J, Mehta SB, Shereefa S, Specht S, Aedo SJ, Goldbach P, Jia F, Kuehnle B, Page S, Voeten L, Yi L, Zhu C. Zamiri C, et al. Among authors: mehta sb. PDA J Pharm Sci Technol. 2023 Oct 17:pdajpst.2022.012806. doi: 10.5731/pdajpst.2022.012806. Online ahead of print. PDA J Pharm Sci Technol. 2023. PMID: 37848203
Three-dimensional spatio-angular fluorescence microscopy with a polarized dual-view inverted selective-plane illumination microscope (pol-diSPIM).
Chandler T, Guo M, Su Y, Chen J, Wu Y, Liu J, Agashe A, Fischer RS, Mehta SB, Kumar A, Baskin TI, Jamouille V, Liu H, Swaminathan V, Nain A, Oldenbourg R, La Riviere P, Shroff H. Chandler T, et al. Among authors: mehta sb. bioRxiv [Preprint]. 2024 Mar 12:2024.03.09.584243. doi: 10.1101/2024.03.09.584243. bioRxiv. 2024. PMID: 38712306 Free PMC article. Preprint.
117 results